Phase 2
Completed N=418
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
Source: ClinicalTrials.gov NCT01373151 ↗Enrolled (actual)
418
Serious AEs
7.9%
Results posted
Dec 2021
Primary outcomePrimary: Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate — 39.3; 76.3; 55.0; 73.3 percentage of participants
Summary
The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate |
39.3; 76.3; 55.0; 73.3; 61.0; 60.0 | — |
| SECONDARY Percent of Participants With ACR 20 Response |
37.7; 81.4; 58.3; 65.0; 57.6; 66.7 | — |
| SECONDARY Percent of Participants Achieving ACR 50 Response Rate |
21.3; 49.2; 26.7; 43.3; 28.8; 26.7 | — |
| SECONDARY Percent of Participants Achieving ACR 70 Response Rate |
8.2; 18.6; 13.3; 26.7; 11.9; 13.3 | — |
| SECONDARY Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) |
-1.15; -2.65; -2.29; -2.68; -2.34; -2.52 | — |
| SECONDARY Percent of Participants With Remission by DAS28-CRP |
1.6; 35.6; 21.7; 35.0; 25.4; 26.7 | — |
| SECONDARY Mean Change From Baseline in Clinical Disease Activity Index (CDAI) |
-14.5; -22.7; -17.7; -23.1; -19.8; -21.0 | — |
| SECONDARY Percent of Participants With Remission by CDAI |
3.3; 11.9; 8.3; 8.3; 3.4; 3.3 | — |
| SECONDARY Mean Change From Baseline in Simplified Disease Activity Index (SDAI) |
-14.5; -24.9; -20.4; -25.3; -22.2; -23.3 | — |
| SECONDARY Percent of Participants With Remission by SDAI |
1.6; 11.9; 8.3; 8.3; 6.8; 5.0 | — |
| SECONDARY Percent of Participants With Remission Rate by Boolean Definition |
3.3; 8.5; 6.7; 10.; 1.7; 5.0 | — |
| SECONDARY Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index |
-0.44; -0.66; -0.47; -0.70; -0.51; -0.60 | — |
| SECONDARY Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components |
5.3; 5.9; 4.5; 7.3; 4.0; 5.7 | — |
| SECONDARY Mean Change From Baseline in Fatigue Severity (VAS) Score |
-14.3; -20.8; -19.4; -27.4; -21.7; -18.6 | — |
| SECONDARY Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores |
-9.6; -2.2; -8.7; -12.0; -13.7; -10.0 | — |
| SECONDARY Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing) |
1.3; 0.4; 1.1; 0.3; 1.0; -0.2 | — |
| SECONDARY Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score |
1.8; 0.3; 0.0; 0.1; 0.1; 0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Inadequate response to Methotrexate
- Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization
- American College of Rheumatology (ACR) global function status class 1-3
- Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
- High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL
Exclusion Criteria
- Previously received or currently receiving concomitant biologic therapy
Data sourced from ClinicalTrials.gov (NCT01373151). 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. Informational only — not medical advice.