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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/NCT02181673
Registration number
NCT02181673
Ethics application status
Date submitted
2/07/2014
Date registered
4/07/2014
Date last updated
21/12/2017
Titles & IDs
Public title
A Study of Golimumab in Participants With Active Psoriatic Arthritis
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriatic Arthritis
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Secondary ID [1]
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2014-000242-30
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Secondary ID [2]
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CR103796
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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:
Arthritis, Psoriatic
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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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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Golimumab
Placebo Comparator: Treatment Group 1: Placebo - Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52.
Experimental: Treatment Group 2: Golimumab - Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants will receive a placebo infusion to maintain the blind.
Treatment: Drugs: Placebo
Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.
Treatment: Drugs: Golimumab
Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.
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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 Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14
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Assessment method [1]
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The ACR 20 response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
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Timepoint [1]
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Week 14
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Secondary outcome [1]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14
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Assessment method [1]
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The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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Timepoint [1]
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Baseline and Week 14
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Secondary outcome [2]
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Percentage of Participants Who Achieved an ACR 50 Response at Week 14
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Assessment method [2]
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The ACR 50 response is defined as: greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
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Timepoint [2]
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Week 14
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Secondary outcome [3]
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Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14
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Assessment method [3]
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The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
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Timepoint [3]
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Week 14
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Secondary outcome [4]
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Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
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Assessment method [4]
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The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively.
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Timepoint [4]
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Baseline and Week 24
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Secondary outcome [5]
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Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline
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Assessment method [5]
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Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
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Timepoint [5]
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Baseline and Week 14
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Secondary outcome [6]
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Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline
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Assessment method [6]
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Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
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Timepoint [6]
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Baseline and Week 14
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Secondary outcome [7]
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Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14
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Assessment method [7]
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The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.
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Timepoint [7]
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Baseline and Week 14
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Secondary outcome [8]
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Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
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Assessment method [8]
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The ACR 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
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Timepoint [8]
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Week 24
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Secondary outcome [9]
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Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14
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Assessment method [9]
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The ACR 70 response is defined as greater than or equal to (>=) 70 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=70% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
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Timepoint [9]
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Week 14
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Secondary outcome [10]
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Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14
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Assessment method [10]
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The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.
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Timepoint [10]
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Baseline and Week 14
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Eligibility
Key inclusion criteria
- Have had psoriatic arthritis (PsA) for at least 6 months prior to the first
administration of study agent
- Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more
tender joints at Screening and at Baseline and C-reactive protein >=0.6 milligram per
deciliter (mg/dL) at Screening
- Have active plaque psoriasis or a documented history of plaque psoriasis
- Have active PsA despite current or previous disease-modifying antirheumatic drugs
(DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is
defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance.
NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID
intolerance
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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
- Have other inflammatory diseases that might confound the evaluations of benefit of
Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing
spondylitis, systemic lupus erythematosus, or Lyme disease
- Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
the study or within 4 months after receiving the last administration of study agent
- Have used any biologic agents that are targeted for reducing tumor necrosis factors
(TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab,
Golimumab, and Certolizumab Pegol
- Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen
mustard, or other Alkylating agents
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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 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
Completed
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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
8/09/2014
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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
22/03/2017
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Sample size
Target
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Accrual to date
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Final
480
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Daw Park
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Recruitment hospital [2]
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- Maroochydore
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Recruitment postcode(s) [1]
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- Daw Park
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Recruitment postcode(s) [2]
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- Maroochydore
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Indiana
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Louisiana
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Mississippi
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Missouri
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New York
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Ontario
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Burlington
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Tver
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Ulyanovsk
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Vladimir
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Yaroslavl
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Spain
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Cordoba
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Spain
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Getafe
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Spain
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Sevilla
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Ukraine
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Chernihiv
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Kryvyi Rih
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Kyiv
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Lviv
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Ukraine
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Odessa
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Ukraine
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Poltava
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Ukraine
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Sumy
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Ukraine
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Ternopil
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Ukraine
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Uzhhorod
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy of intravenously (administration of a
fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants
with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with
psoriasis).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02181673
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02181673
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