Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
- Conditions
- Arthritis, Psoriatic
- Interventions
- Biological: Placebo matching BMS-945429Biological: BMS-945429
- Registration Number
- NCT01490450
- Lead Sponsor
- CSL Behring
- Brief Summary
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed
- Inadequate response to NSAID and/or non-biologic DMARD
- Minimum of 3 swollen and 3 tender joints
- Active psoriatic skin lesions over minimum 3% body surface area
- high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL
- Previously received or currently receiving concomitant biologic therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PBO: Placebo matching BMS-945429 Placebo matching BMS-945429 - BMS-945429 (200mg) BMS-945429 - BMS-945429 (25mg) BMS-945429 - BMS-945429 (100mg) BMS-945429 -
- Primary Outcome Measures
Name Time Method Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20) At 16 weeks The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
- Secondary Outcome Measures
Name Time Method Number of Participants With Anti-clazakizumab Antibodies Up to 24 weeks Percent of Participants Achieving ACR50 and ACR70 Response Rate Week 16 and Week 24 The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Percent of Participants Achieving ACR20 Response Rate at Week 24 Week 24 The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Weeks 16 and Week 24 For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). There are 20 questions in eight categories of functioning - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The highest component score in each category determines the score for the category, unless aids or devices are required. Dependence on equipment or physical assistance increases a lower score to the level of 2 to more accurately represent underlying disability. The eight category scores are averaged into an overall HAQ score on a scale from zero (no disability) to three (completely disabled). The scale is not truly continuous but has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 ... 3).
Response is measured by a reduction of at least 0.3 unit from baseline in HAQ index.Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate Week 16 and Week 24 To calculate the PASI score, the psoriasis plaques found on each body region are graded for their combined redness, thickness, and scaliness. The severity of the plaques in each region is graded on a 0 to 4 scale, with 0 meaning no involvement and 4 meaning severe involvement. Next, the amount of surface area on each body region that is covered by the plaques is calculated. The total surface area affected by psoriasis is graded from 0 to 6, with 0 meaning no involvement and 6 meaning greater than 90 percent of the region covered in plaques.
These grades are then fed into an equation to determine the patient's PASI score. The PASI score then is used as a clinical assessment of the patient's psoriasis involvement. A person free of psoriasis has a score of 0 and the score could be as high as 72.
PASI 75 means that the person's PASI score dropped by 75 percent as a result of the psoriasis treatment.Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores Baseline and Week 16 The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.
Mean Change From Baseline at Week 24 in SF-36 Scores Baseline and Week 24 The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.
Trial Locations
- Locations (12)
Local Institution
🇪🇸Sevilla, Spain
Centre De Rhumatologie De L Est Du Quebec
🇨🇦Rimouski, Quebec, Canada
Sarasota Arthritis Research Center
🇺🇸Sarasota, Florida, United States
East Penn Rheumatology Associates, P.C.
🇺🇸Bethlehem, Pennsylvania, United States
New England Research Associates, Llc
🇺🇸Trumbull, Connecticut, United States
Arthritis Associates Of Mississippi
🇺🇸Jackson, Mississippi, United States
Box Arthritis And Rheumatology Of The Carolinas, Pllc
🇺🇸Charlotte, North Carolina, United States
Manitoba Clinic
🇨🇦Winnipeg, Manitoba, Canada
San Diego Arthritis Medical Clinic
🇺🇸San Diego, California, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
Health Research Of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Centre De Recherche Musculo-Squelettique
🇨🇦Trois-rivieres, Quebec, Canada