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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02531633
Registration number
NCT02531633
Ethics application status
Date submitted
6/07/2015
Date registered
24/08/2015
Date last updated
31/07/2019
Titles & IDs
Public title
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients With Giant Cell Arteritis
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Secondary ID [1]
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201677
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Giant Cell Arteritis
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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Other neurological disorders
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Inflammatory and Immune System
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sirukumab
Treatment: Drugs - Placebo to match sirukumab
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo to match prednisone
Experimental: Part A: Sirukumab, Dose 1+prednisone (6-month taper) - Subjects will receive blinded sirukumab 100 mg subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.
Experimental: Part A: Sirukumab, Dose 1+prednisone (3-month taper) - Subjects will receive blinded sirukumab 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month oral prednisone taper regimen.
Experimental: Part A: Sirukumab, Dose 2+prednisone (6-month taper) - Subjects will receive blinded sirukumab 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.
Placebo Comparator: Part A:Placebo to match sirutkumab+prednisone (6-month taper) - Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 6-month oral prednisone taper regimen.
Placebo Comparator: Part A:Placebo to match sirukumab+prednisone (12-month taper) - Subjects will receive blinded placebo to match sirutkumab q2w for 52 weeks plus a pre-specified maximum of 12-month oral prednisone taper regimen.
Experimental: Part B:Open-label sirukumab 100 mg SC (if applicable) - Subjects completing Part A will receive open label 100 mg SC q2w for a maximum of 52 weeks based on remission status and disease activity at the primary 52-week endpoint or prednisone tapering status of subject during Part A. Methotrexate will be provided to subjects, alone or in addition to sirukumab treatment during Part B, based on the discretion of the investigator.
Treatment: Drugs: Sirukumab
Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukuma, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.
Treatment: Drugs: Placebo to match sirukumab
Placebo to match sirukumab will be provided as 1.0 mL PFS fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.
Treatment: Drugs: Prednisone
Prednisone will be provided as tablets with dosage level up to-60 mg/day. The prednisone dose for all subjects will be determined by the Investigator and starting doses will be within 20-60 mg prednisone at Baseline (Randomization).
Treatment: Drugs: Placebo to match prednisone
Placebo to match prednisone will be provided as tablets.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Number of Participants in Sustained Remission at Week 52
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Assessment method [1]
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Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) [<30 millimeters per hour] and C-reactive Protein (CRP) [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24
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Assessment method [1]
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Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30 millimeters per hour] and CRP [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Part A: Cumulative Prednisone Dose Over Time
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Assessment method [2]
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Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg.
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Timepoint [2]
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Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [3]
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Part B: Number of Participants in Sustained Remission Over Time
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Assessment method [3]
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Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis.
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Timepoint [3]
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Weeks 4, 8 and 12
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Secondary outcome [4]
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Part A: Time to First Disease Flare After Clinical Remission
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Assessment method [4]
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Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented.
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Timepoint [4]
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Week 52
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Secondary outcome [5]
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Part B: Time to First Disease Flare for Participants in Sustained Remission
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Assessment method [5]
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Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented.
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Timepoint [5]
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Week 52
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Secondary outcome [6]
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Part A: Number of Disease Flares Over Time
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Assessment method [6]
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This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented.
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Timepoint [6]
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Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [7]
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Part A: Number of Participants With at Least One Hospitalization for Disease Flare
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Assessment method [7]
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Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented.
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Timepoint [7]
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Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [8]
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Part A: Number of Hospitalizations for Disease Flare Over Time
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Assessment method [8]
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Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented.
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Timepoint [8]
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Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [9]
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Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
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Assessment method [9]
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SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented.
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Timepoint [9]
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Baseline (Week 0), Weeks 12, 24, 36, 52
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Secondary outcome [10]
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Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
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Assessment method [10]
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EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score).
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Timepoint [10]
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Baseline (Week 0) and Weeks 12, 24, 36, 52
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Secondary outcome [11]
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Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
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Assessment method [11]
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EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'.
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Timepoint [11]
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Baseline (Week 0) and Weeks 12, 24, 36, 52
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Secondary outcome [12]
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Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
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Assessment method [12]
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The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items.
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Timepoint [12]
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Baseline (Week 0), Weeks 12, 24, 36, 52
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Secondary outcome [13]
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Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
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Assessment method [13]
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The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Data for NRS scores over time for part A is reported.
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Timepoint [13]
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Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [14]
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Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
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Assessment method [14]
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Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability.
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Timepoint [14]
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Baseline (Week 0) and Weeks 12, 24, 36 and 52
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Secondary outcome [15]
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Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
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Assessment method [15]
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Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
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Timepoint [15]
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Weeks 12, 24 and 52
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Secondary outcome [16]
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Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
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Assessment method [16]
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The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor").
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Timepoint [16]
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [17]
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Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
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Assessment method [17]
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The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 ("none") to 10 ("extremely active").
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Timepoint [17]
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [18]
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Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
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Assessment method [18]
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Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP.
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Timepoint [18]
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [19]
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Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
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Assessment method [19]
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Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported.
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Timepoint [19]
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [20]
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Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs
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Assessment method [20]
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An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs have been reported.
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Timepoint [20]
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Up to 52 weeks
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Secondary outcome [21]
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Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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Assessment method [21]
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SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [21]
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Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [22]
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Part A: Change From Baseline in Pulse Rate
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Assessment method [22]
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Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [22]
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Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [23]
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Part A: Change From Baseline in Temperature
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Assessment method [23]
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Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [23]
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Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [24]
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Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
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Assessment method [24]
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Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [24]
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Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [25]
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Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
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Assessment method [25]
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Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [25]
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Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [26]
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Part A: Change From Baseline in Hematology Parameter-Hematocrit
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Assessment method [26]
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Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [26]
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Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [27]
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Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
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Assessment method [27]
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Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [27]
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Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [28]
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Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
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Assessment method [28]
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Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [28]
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Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [29]
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Part A:Change From Baseline in Hematology Parameter- Erythrocytes
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Assessment method [29]
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Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [29]
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0
Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [30]
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Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
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Assessment method [30]
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Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [30]
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Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [31]
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Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
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Assessment method [31]
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Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [31]
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0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [32]
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Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
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Assessment method [32]
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Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [32]
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Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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Secondary outcome [33]
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Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
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Assessment method [33]
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Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
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Timepoint [33]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Query!
Secondary outcome [34]
0
0
Part A: Mean Serum Concentrations of Sirukumab
Query!
Assessment method [34]
0
0
Blood samples for Pharmacokinetic analysis of sirukumab serum concentrations were planned to be collected at specified time points.
Query!
Timepoint [34]
0
0
Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52
Query!
Secondary outcome [35]
0
0
Part A: Mean Serum Anti-sirukumab Antibodies
Query!
Assessment method [35]
0
0
Blood samples for Pharmacokinetic analysis of Serum anti-sirukumab antibodies were planned to be collected at specified time points.
Query!
Timepoint [35]
0
0
Baseline (Week 0) and up to 52 weeks
Query!
Secondary outcome [36]
0
0
Part A: Change From Baseline in Free and Total Interleukin-6 (IL-6) Over Time
Query!
Assessment method [36]
0
0
Blood samples for Pharmacodynamic analysis were planned but not collected due to early termination of study.
Query!
Timepoint [36]
0
0
Baseline (Week 0) and up to 52 weeks
Query!
Secondary outcome [37]
0
0
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [37]
0
0
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
Query!
Timepoint [37]
0
0
Up to 120 weeks
Query!
Secondary outcome [38]
0
0
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B
Query!
Assessment method [38]
0
0
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
Query!
Timepoint [38]
0
0
Up to 120 weeks
Query!
Secondary outcome [39]
0
0
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [39]
0
0
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [39]
0
0
Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Query!
Secondary outcome [40]
0
0
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [40]
0
0
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [40]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Query!
Secondary outcome [41]
0
0
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [41]
0
0
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [41]
0
0
Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Query!
Secondary outcome [42]
0
0
Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [42]
0
0
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented.
Query!
Timepoint [42]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Query!
Secondary outcome [43]
0
0
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [43]
0
0
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [43]
0
0
Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)
Query!
Secondary outcome [44]
0
0
Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [44]
0
0
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [44]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)
Query!
Secondary outcome [45]
0
0
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [45]
0
0
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [45]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [46]
0
0
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [46]
0
0
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [46]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [47]
0
0
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [47]
0
0
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [47]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [48]
0
0
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [48]
0
0
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [48]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [49]
0
0
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [49]
0
0
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [49]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [50]
0
0
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [50]
0
0
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [50]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [51]
0
0
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [51]
0
0
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [51]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [52]
0
0
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [52]
0
0
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [52]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [53]
0
0
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [53]
0
0
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Query!
Timepoint [53]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [54]
0
0
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [54]
0
0
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [54]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [55]
0
0
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [55]
0
0
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Query!
Timepoint [55]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [56]
0
0
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [56]
0
0
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [56]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [57]
0
0
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [57]
0
0
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Query!
Timepoint [57]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [58]
0
0
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [58]
0
0
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [58]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [59]
0
0
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [59]
0
0
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [59]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [60]
0
0
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [60]
0
0
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [60]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [61]
0
0
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [61]
0
0
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [61]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [62]
0
0
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [62]
0
0
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented
Query!
Timepoint [62]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [63]
0
0
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [63]
0
0
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Query!
Timepoint [63]
0
0
Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [64]
0
0
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [64]
0
0
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [64]
0
0
Baseline (Week 0) and Weeks 4,8,12,16,24 and 36
Query!
Secondary outcome [65]
0
0
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Query!
Assessment method [65]
0
0
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented.
Query!
Timepoint [65]
0
0
Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
Query!
Secondary outcome [66]
0
0
Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Query!
Assessment method [66]
0
0
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented.
Query!
Timepoint [66]
0
0
Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38
Query!
Secondary outcome [67]
0
0
Part B: Number of Disease Flares Over Time
Query!
Assessment method [67]
0
0
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented.
Query!
Timepoint [67]
0
0
Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [68]
0
0
Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare
Query!
Assessment method [68]
0
0
Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: "Severe Flare including Hospitalizations". Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
Query!
Timepoint [68]
0
0
Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [69]
0
0
Part B: Number of Hospitalizations for Disease Flare Over Time
Query!
Assessment method [69]
0
0
Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: "Severe Flare including Hospitalizations". Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
Query!
Timepoint [69]
0
0
Up to Week 104
Query!
Secondary outcome [70]
0
0
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [70]
0
0
SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [70]
0
0
Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24
Query!
Secondary outcome [71]
0
0
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Query!
Assessment method [71]
0
0
SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [71]
0
0
Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12
Query!
Secondary outcome [72]
0
0
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [72]
0
0
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [72]
0
0
Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24
Query!
Secondary outcome [73]
0
0
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Query!
Assessment method [73]
0
0
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [73]
0
0
Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12
Query!
Secondary outcome [74]
0
0
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [74]
0
0
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [74]
0
0
Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24
Query!
Secondary outcome [75]
0
0
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Query!
Assessment method [75]
0
0
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Query!
Timepoint [75]
0
0
Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
Query!
Secondary outcome [76]
0
0
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [76]
0
0
The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [76]
0
0
Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
Query!
Secondary outcome [77]
0
0
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Query!
Assessment method [77]
0
0
The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Query!
Timepoint [77]
0
0
Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24
Query!
Secondary outcome [78]
0
0
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [78]
0
0
Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability
Query!
Timepoint [78]
0
0
Day 87, 339, 344, Week 12, 24
Query!
Secondary outcome [79]
0
0
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Query!
Assessment method [79]
0
0
Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability
Query!
Timepoint [79]
0
0
Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12
Query!
Secondary outcome [80]
0
0
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [80]
0
0
The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [80]
0
0
Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344
Query!
Secondary outcome [81]
0
0
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Query!
Assessment method [81]
0
0
The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Query!
Timepoint [81]
0
0
Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373
Query!
Secondary outcome [82]
0
0
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [82]
0
0
In PhGA was based on "What is physician's assessment of the participant's current disease activity". PhGA used a 10 cm VAS ranging from 0 ("none") to 10 ("extremely active"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [82]
0
0
Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40
Query!
Secondary outcome [83]
0
0
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Query!
Assessment method [83]
0
0
In PhGA was based on "What is physician's assessment of the participant's current disease activity". PhGA used a 10 cm VAS ranging from 0 ("none") to 10 ("extremely active"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Query!
Timepoint [83]
0
0
Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373
Query!
Secondary outcome [84]
0
0
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [84]
0
0
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Query!
Timepoint [84]
0
0
Baseline (Day 1), Days 103 and 271
Query!
Secondary outcome [85]
0
0
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Query!
Assessment method [85]
0
0
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Query!
Timepoint [85]
0
0
Baseline (Day 1)
Query!
Secondary outcome [86]
0
0
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [86]
0
0
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [86]
0
0
Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [87]
0
0
Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Query!
Assessment method [87]
0
0
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [87]
0
0
Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Query!
Secondary outcome [88]
0
0
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [88]
0
0
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [88]
0
0
Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40
Query!
Secondary outcome [89]
0
0
Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Query!
Assessment method [89]
0
0
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [89]
0
0
Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36
Query!
Secondary outcome [90]
0
0
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Query!
Assessment method [90]
0
0
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [90]
0
0
Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24
Query!
Secondary outcome [91]
0
0
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Query!
Assessment method [91]
0
0
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Query!
Timepoint [91]
0
0
Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12
Query!
Eligibility
Key inclusion criteria
- Diagnosis of GCA defined by the following Revised GCA Diagnosis Criteria:
Age >=50 years. History of ESR >=50 millimeter/hour (mm/hour) or CRP >=2.45
milligram/deciliter(mg/dL).
Presence of at least one of the following: Unequivocal cranial symptoms of GCA; Unequivocal
symptoms of polymyalgia rheumatic (PMR).
Presence of at least one of the following: Temporal artery biopsy revealing features of
GCA; Evidence of large-vessel vasculitis by angiography or cross-sectional imaging.
- Active GCA within 6 weeks of Randomization (Baseline) where active disease is defined
by an ESR >=30 mm/hr or CRP >=1 mg/dL AND the presence of at least one of the
following:
Unequivocal cranial symptoms of GCA; Unequivocal symptoms of PMR; Other features judged by
the clinician investigator to be consistent with GCA or PMR flares.
- At screening, receiving or able to receive prednisone 20-60 mg/day for the treatment
of active GCA.
- Clinically stable GCA disease at baseline such that the subject is able to safely
participate in the blinded prednisone taper regimen in the opinion of the
investigator.
- Practicing acceptable methods of birth control if a female of child-bearing potential.
- No evidence of active or latent infection with Mycobacterium tuberculosis (TB).
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Are pregnant or breastfeeding.
- Recent (within the past 12 weeks) or planned major surgery that would impact on study
procedures or assessments.
- Organ transplantation recipients (except corneas within 3 months prior to baseline
visit).
- Had prior treatment with any of the following:
Systemic immunosuppressives) within 4 weeks of baseline; Biologic agents targeted at
reducing tumor necrosis factor-alpha (TNF-alpha) within 2-8 weeks of baseline, depending on
the agent; Any prior use of tocilizumab or other anti-IL-6 agents; B-cell depleting agents
(eg, rituximab) within 12 months prior to baseline or longer if B cell counts have not
returned to normal range or baseline levels; Cytotoxic drugs such as cyclophosphamide,
chlorambucil, nitrogen mustard, or other alkylating agents within 4 weeks of baseline;
Abatacept within 8 weeks of baseline; Tofacitinib within 4 weeks of baseline; Methotrexate
use within 2 weeks of baseline.
Methylprednisolone > 100 mg/day intravenous (IV) (or equivalent) within 8 weeks of
baseline.
- History of severe allergic reactions to monoclonal antibodies, human proteins, or
excipients.
- Evidence of serious concomitant disease, which in the opinion of the investigator
makes them unsuitable for participation in the study.
- Major ischemic event, unrelated to GCA, within 12 weeks of screening.
- Marked baseline prolongation of corrected QT (QTc) interval >= 450 milliseconds (msec)
(QTc by Bazett's formula [QTcB ]or QTc by Fridericia's formula [QTcF] ), history of
Torsade de Pointes, family history of long QT syndrome, history of second or third
degree heart block.
- Current liver disease that could interfere with the trial
- History of or current active diverticulitis, inflammatory bowel disease, or other
symptomatic gastrointestinal tract condition that might predispose to bowel
perforation.
- History of known demyelinating diseases such as multiple sclerosis or optic neuritis.
- Active infections, or history of recurrent infections or have required management of
acute or chronic infections, as follows:
Currently on any suppressive therapy for a chronic infection, history or suspicion of
chronic infection, hospitalization for treatment of infection within 60 days of the
baseline visit, or use of parenteral (IV) or intra-muscular [IM]) antimicrobials within 60
days of baseline or oral antimicrobials within 30 days of baseline
- Primary or secondary immunodeficiency or any other autoimmune disease.
- Human immunodeficiency virus (HIV) infection, hepatitis C or hepatitis B infection
- Live virus or bacterial vaccination within 3 months before the first administration of
study drug
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/10/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
21/03/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
161
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Camperdown
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Kogarah
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Woodville
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Heidelberg
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Malvern East
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Victoria Park
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [4]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [5]
0
0
3145 - Malvern East
Query!
Recruitment postcode(s) [6]
0
0
6100 - Victoria Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Colorado
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Iowa
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Minnesota
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Tennessee
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Texas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Washington
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Leuven
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Liège
Query!
Country [13]
0
0
Bulgaria
Query!
State/province [13]
0
0
Plovdiv
Query!
Country [14]
0
0
Bulgaria
Query!
State/province [14]
0
0
Sofia
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Bobigny
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Orleans
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Paris
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Baden-Wuerttemberg
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Niedersachsen
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Nordrhein-Westfalen
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Sachsen
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Thueringen
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Bad Abbach
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Berlin
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Hamburg
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Kirchheim unter Teck
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
München
Query!
Country [28]
0
0
Hungary
Query!
State/province [28]
0
0
Budapest
Query!
Country [29]
0
0
Hungary
Query!
State/province [29]
0
0
Debrecen
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Emilia-Romagna
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Lombardia
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Rozzano
Query!
Country [33]
0
0
Netherlands
Query!
State/province [33]
0
0
Almelo
Query!
Country [34]
0
0
Netherlands
Query!
State/province [34]
0
0
Groningen
Query!
Country [35]
0
0
Netherlands
Query!
State/province [35]
0
0
Nijmegen
Query!
Country [36]
0
0
New Zealand
Query!
State/province [36]
0
0
Hamilton
Query!
Country [37]
0
0
New Zealand
Query!
State/province [37]
0
0
Timaru
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Krakow
Query!
Country [39]
0
0
Spain
Query!
State/province [39]
0
0
Barcelona
Query!
Country [40]
0
0
Spain
Query!
State/province [40]
0
0
Bilbao
Query!
Country [41]
0
0
Spain
Query!
State/province [41]
0
0
La Coruña
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Spain
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La Laguna
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United Kingdom
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Essex
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United Kingdom
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Merseyside
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United Kingdom
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Suffolk
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United Kingdom
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Yorkshire
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United Kingdom
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Edinburgh
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United Kingdom
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Leeds
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United Kingdom
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Oxford
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United Kingdom
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Reading
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Funding & Sponsors
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Commercial sector/Industry
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Name
GlaxoSmithKline
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Summary
Brief summary
Sirukumab is a fully human anti-interleukin-6 (IL-6) immunoglobulin G1-kappa with a high
affinity and specificity for binding to the human IL-6 molecule that may have therapeutic
benefit in the treatment of giant cell arteritis (GCA) by interruption of multiple pathogenic
pathways. Sirukumab inhibits IL-6-mediated signal transducer and activator of transcription 3
(STAT3) phosphorylation, resulting in the inhibition of the biological effect of IL-6. This
study will evaluate the efficacy and safety of sirukumab to characterize the benefit-to-risk
profile of sirukumab in the treatment of active GCA. The study will be conducted in 2
distinct parts (Part A and Part B) and consists of the following phases: Screening phase,
Part A: 52-week double-blind treatment phase, Part B: 104-week extension phase with the
option to receive open-label sirukumab based on disease status and a 16-week follow-up phase
if applicable.
Approximately 204 subjects with a diagnosis of GCA and active disease within 6 weeks of
baseline will be randomized into Part A, the 52-week double-blind treatment phase, to receive
one of two doses of sirukumab or placebo, each in addition to a pre-specified prednisone
taper. The efficacy and safety of sirukumab in sustaining remission will be assessed at Week
52. Subjects completing Part A of the study will be eligible to enter Part B, the 104-week
extension phase, designed to investigate the long-term maintenance of remission and safety
following cessation of sirukumab treatment and to assess long-term corticosteroid use.
Subjects with active GCA at the end of Part A or those with new onset of GCA flare during the
first 52 weeks of Part B will be eligible to receive open-label sirukumab. Subjects will need
to have follow-up safety evaluations for at least 16 weeks after receiving the last dose of
study drug, applicable only for those who are withdrawn prematurely from the study or whose
open-label sirukumab treatment in Part B completes after Week 88.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02531633
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02531633
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