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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/NCT01202773
Registration number
NCT01202773
Ethics application status
Date submitted
14/09/2010
Date registered
16/09/2010
Date last updated
14/05/2018
Titles & IDs
Public title
A Study in Participants With Rheumatoid Arthritis
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Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-a Inhibitors (FLEX V)
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Secondary ID [1]
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H9B-MC-BCDV
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Secondary ID [2]
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13732
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Universal Trial Number (UTN)
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Trial acronym
FLEX V
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LY2127399
Treatment: Drugs - Placebo Q4W
Treatment: Drugs - Placebo Q2W
Experimental: 120 milligrams (mg) LY2127399 - Given every 4 weeks (Q4W) for 24 weeks. Participants receive a 240-mg loading dose when initiating treatment.
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W).
At Week 16, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period.
At Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Experimental: 90 mg LY2127399 - Given Q2W for 24 weeks. Participants receive a 180-mg loading dose when initiating treatment.
At Week 16, both responders and NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Placebo Comparator: Placebo - Given Q2W for 24 weeks. Participants receive 2 injections of placebo when initiating treatment.
At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
At Week 16, NR will receive a 180-mg loading dose of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Treatment: Drugs: LY2127399
Administered Subcutaneously (SC)
Treatment: Drugs: Placebo Q4W
Administered SC
Treatment: Drugs: Placebo Q2W
Administered SC
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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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Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
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Assessment method [1]
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ACR Responder Index: composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: a =20% improvement from baseline in both 68 tender joint counts (TJC) and 66 swollen joint counts (SJC) and a =20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response = (number of ACR20 responders / number of participants treated) * 100. All NR at Week 16, as well as all participants who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
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Timepoint [1]
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Baseline through Week 24
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Secondary outcome [1]
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Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
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Assessment method [1]
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ACR Responder Index: composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had a =50% improvement from baseline in both 68 TJC and 66 SJC and a =50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response = [number (No.) of ACR50 responders / No. of Pts treated]*100. ACR70 Responder: had a =70% improvement from baseline in both TJC and SJC and a =70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response = (No. of ACR70 responders / No. of Pts treated)*100. All NR at Week 16, as well as all Pts who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.
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Timepoint [1]
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Baseline through Week 24
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Secondary outcome [2]
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American College of Rheumatology Percent Improvement (ACR-N)
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Assessment method [2]
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ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJC, b) % change in SJC, or c) the median % change of remaining 5 ACR core criteria: If =3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline Disease Activity Score based on 28 joint counts -CRP (DAS28-CRP) as a covariate.
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Timepoint [2]
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Baseline through Week 24
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Secondary outcome [3]
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Change From Baseline to Week 24 in Tender Joint Count (68 Joint Count)
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Assessment method [3]
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Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [3]
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Baseline, Week 24
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Secondary outcome [4]
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Change From Baseline to Week 24 in Swollen Joint Count (66 Joint Count)
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Assessment method [4]
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Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [4]
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Baseline, Week 24
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Secondary outcome [5]
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Change From Baseline to Week 24 in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
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Assessment method [5]
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Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [5]
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Baseline, Week 24
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Secondary outcome [6]
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Change From Baseline to Week 24 in Participant's Global Assessment of Disease Activity (VAS)
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Assessment method [6]
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Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [6]
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Baseline, Week 24
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Secondary outcome [7]
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Change From Baseline to Week 24 in Physician's Global Assessment of Disease Activity (VAS)
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Assessment method [7]
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Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [7]
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Baseline, Week 24
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Secondary outcome [8]
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Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)
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Assessment method [8]
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The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [8]
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Baseline, Week 24
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Secondary outcome [9]
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Change From Baseline to Week 24 in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)
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Assessment method [9]
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Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter), and participant's global assessment of disease activity using VAS (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0 to 9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [9]
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Baseline, Week 24
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Secondary outcome [10]
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Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response
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Assessment method [10]
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EULAR Responder index categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP=0.56*sqrt(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response = ( number of participants with specific response) / (number of participants analyzed in the group) * 100.
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Timepoint [10]
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Baseline through Week 24
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Secondary outcome [11]
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Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores
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Assessment method [11]
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SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. If < 50% of the questions within a domain were answered, the raw score were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher score indicating better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.
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Timepoint [11]
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Baseline, Week 24
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Secondary outcome [12]
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Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores
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Assessment method [12]
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The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, the first item is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [12]
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Baseline, Week 24
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Secondary outcome [13]
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Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores
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Assessment method [13]
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The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24 hours and pain based on the pain right now, with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in the past 24 hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [13]
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Baseline, Week 24
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Secondary outcome [14]
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Change From Baseline to Week 24 in Duration of Morning Stiffness (Minutes)
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Assessment method [14]
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The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [14]
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Baseline, Week 24
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Secondary outcome [15]
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Time to ACR20 Response
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Assessment method [15]
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Timepoint [15]
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Baseline through Week 24
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Secondary outcome [16]
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Change From Baseline to Week 24 in Absolute B Cell Counts
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Assessment method [16]
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Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [16]
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Baseline, Week 24
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Secondary outcome [17]
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Change From Baseline to Week 24 in Serum Immunoglobulin (Ig) Levels
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Assessment method [17]
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Immunoglobulin (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [17]
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Baseline, Week 24
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Secondary outcome [18]
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Population Pharmacokinetics (PK): Constant Clearance
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Assessment method [18]
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Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
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Timepoint [18]
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Baseline through Week 24
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Secondary outcome [19]
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Percentage of Participants Developing Anti-LY2127399 Antibodies
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Assessment method [19]
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Participants with treatment-emergent anti-drug antibody (ADA) were participants who had any sample from baseline up to and through Week 52 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of =1:20). Percentage of participants with ADA = (number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.
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Timepoint [19]
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Baseline through Week 24
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Secondary outcome [20]
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Change From Baseline to Week 24 in CRP
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Assessment method [20]
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CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
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Timepoint [20]
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Baseline, Week 24
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Eligibility
Key inclusion criteria
- Diagnosis of RA of more than 6 months and less than 15 years
- At least 8 tender and swollen joints
- An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate
(ESR)
- Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP)
antibody
- Previously treated with biologic TNF-a inhibitor therapy (infliximab, certolizumab,
golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy
or intolerance
- Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD),
with a stable dose for at least 8 weeks prior to study start
- Woman must not be pregnant, breastfeeding, or become pregnant during the study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6
weeks
- Steroid injection or intravenous (IV) infusion in the last 6 weeks
- Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks
- History of a serious reaction to other biological DMARDs
- Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the
last 8 weeks
- Surgery on a joint or other major surgery less than 2 months ago, or plans to have
joint surgery or major surgery during the study
- Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,
ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition
except RA
- Cervical cancer or squamous skin cancer within the past 3 years, or other cancer
within the past 5 years
- Received a live vaccine received within the past 12 weeks (for example, vaccines for
measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
- Hepatitis or human immunodeficiency virus (HIV)
- A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months
or a serious bone or joint infection within 6 months
- Symptoms of herpes zoster or herpes simplex within the last month
- Active or latent tuberculosis (TB)
- Current symptoms of a serious disorder or illness
- Use of an investigational drug within the last month
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2014
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Sample size
Target
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Accrual to date
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Final
456
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Kogarah
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Recruitment hospital [2]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Herston
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Recruitment hospital [3]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Malvern East
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Recruitment postcode(s) [1]
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04266-010 - Kogarah
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3145 - Malvern East
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Recruitment outside Australia
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Argentina
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Argentina
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Quilmes
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Argentina
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Brazil
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Brazil
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France
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France
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Taipei
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Funding & Sponsors
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Commercial sector/Industry
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Name
Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the
treatment of rheumatoid arthritis in participants with an inadequate response to one or more
tumor necrosis factor-alpha (TNF-a) inhibitors.
This study is comprised of 2 periods:
Period 1: 24-week blinded treatment
Period 2: 48-week post-treatment follow-up
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01202773
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Public notes
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Contacts
Principal investigator
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0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01202773
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