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

Browse trials for

• Arthritis 3,554
• Arthritis, Psoriatic 579

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 165 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

Study arms

• Placebo comparator
  PBO: Placebo matching BMS-945429

  Biological: Placebo matching BMS-945429

• Experimental
  BMS-945429 (25mg)

  Biological: BMS-945429

• Experimental
  BMS-945429 (100mg)

  Biological: BMS-945429

• Experimental
  BMS-945429 (200mg)

  Biological: BMS-945429

Interventions

• BiologicalPlacebo matching BMS-945429

  Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

• BiologicalBMS-945429

  Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

• BiologicalBMS-945429

  Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

• BiologicalBMS-945429

  Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Primary outcomes

1. Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)

   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).

   Time frame: At 16 weeks

Secondary outcomes

1. Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate

   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.

   Time frame: Week 16 and Week 24

2. Percent of Participants Achieving ACR50 and ACR70 Response Rate

   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).

   Time frame: Week 16 and Week 24

3. Percent of Participants Achieving ACR20 Response Rate at 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).

   Time frame: Week 24

4. Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response

   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.

   Time frame: Weeks 16 and Week 24

5. Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores

   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.

   Time frame: Baseline and Week 16

6. Mean Change From Baseline at Week 24 in SF-36 Scores

   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.

   Time frame: Baseline and Week 24

7. Number of Participants With Anti-clazakizumab Antibodies

   Time frame: Up to 24 weeks

Baseline characteristics

Publications

• Mease PJ, Gottlieb AB, Berman A, Drescher E, Xing J, Wong R, Banerjee S. The Efficacy and Safety of Clazakizumab, an Anti-Interleukin-6 Monoclonal Antibody, in a Phase IIb Study of Adults With Active Psoriatic Arthritis. Arthritis Rheumatol. 2016 Sep;68(9):2163-73. doi: 10.1002/art.39700. PubMed 27059799 ↗

Related links

• BMS clinical trial educational resource ↗
• Investigator Inquiry form ↗