Phase 2
N=165
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
Arthritis, Psoriatic
Bottom Line
View on ClinicalTrials.gov: NCT01490450 ↗Enrolled (actual)
165
Serious AEs
6.1%
Results posted
Nov 2021
Primary outcome: Primary: Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20) — 29.3; 46.3; 52.4; 39.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo matching BMS-945429 (Biological); BMS-945429 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20) |
29.3; 46.3; 52.4; 39.0 | — |
| SECONDARY Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate |
14.6; 12.2; 16.7; 4.9; 12.2; 19.5 | — |
| SECONDARY Percent of Participants Achieving ACR50 and ACR70 Response Rate |
7.3; 29.3; 35.7; 17.1; 14.6; 34.1 | — |
| SECONDARY Percent of Participants Achieving ACR20 Response Rate at Week 24 |
34.1; 56.1; 57.1; 39.0 | — |
| SECONDARY Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response |
36.6; 48.8; 45.2; 39.0; 26.8; 51.2 | — |
| SECONDARY Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores |
1.4; 1.2; 3.7; 1.1; 4.4; 6.5 | — |
| SECONDARY Mean Change From Baseline at Week 24 in SF-36 Scores |
3.6; 1.4; 3.9; 2.1; 4.9; 8.2 | — |
| SECONDARY Number of Participants With Anti-clazakizumab Antibodies |
1; 0; 1 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Previously received or currently receiving concomitant biologic therapy
Data sourced from ClinicalTrials.gov (NCT01490450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.