Phase 2
Completed N=247
Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02638948 ↗Enrolled (actual)
247
Serious AEs
2.4%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 — 30.7; 35.6; 42.5; 30.8 Percentage of participants — p=0.5224
Summary
The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 |
30.7; 35.6; 42.5; 30.8 | 0.5224 |
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12 |
4.0; 4.1; 9.6; 3.8 | 1.0000 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12 |
0.0; 0.0; 0.0; 0.0; 10.7; 13.7 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12 |
0; 0; 0; 0; 2.7; 4.1 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12 |
0; 0; 0; 0; 1.3; 0.0 | — |
| SECONDARY Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12 |
6.7; 9.6; 11.0; 0.0 | — |
| SECONDARY Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12 |
0.0; 6.8; 1.4; 0.0 | — |
| SECONDARY Percentage of Participants Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12 |
0.0; 6.8; 6.8; 0.0 | — |
| SECONDARY Percentage of Participants Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12 |
0.0; 6.8; 6.8; 0.0 | — |
| SECONDARY Percentage of Participants Achieving Boolean Remission Criteria at Week 12 |
1.3; 4.1; 4.1; 0.0 | — |
| SECONDARY Change From Baseline in DAS28-CRP Score Over Time up to Week 12 |
-1.1; -1.1; -1.4; -1.4 | — |
| SECONDARY Change From Baseline in DAS28-ESR Score Over Time up to Week 12 |
-1.1; -1.1; -1.4; -1.5 | — |
| SECONDARY Change From Baseline in CDAI Score Over Time up to Week 12 |
-14.9; -13.6; -16.0; -17.6 | — |
| SECONDARY Change From Baseline in SDAI Score Over Time up to Week 12 |
-14.8; -13.9; -16.6; -18.9 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), and Serious AEs (SAEs) |
36; 39; 39; 19; 4; 2 | — |
| SECONDARY Trough Observed Plasma Concentration (Ctrough) of BMS-986142 |
47.9; 111.8; 195.9; 41.2; 92.2; 283.0 | — |
| SECONDARY Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Synovitis at Week 4 and 12 |
0.1; -0.2; 0.1; 0.1; 0.7; -0.0 | — |
| SECONDARY Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Osteitis at Week 4 and 12 |
0.1; 0.2; 0.1; -0.1; 0.4; 0.5 | — |
| SECONDARY Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Bone Erosion at Week 4 and 12 |
0.1; 0.1; -0.0; 0.0; 0.1; 0.3 | — |
| SECONDARY Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Cartilage Loss at Week 4 and 12 |
0.1; 0.0; -0.0; 0.4; 0.0; 0.3 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Male and female age 18 and above
- Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III
- Have an inadequate response to methotrexate
- In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors
- Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)
- Have hsCRP of ≥ 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR ≥ 28 mm/hr
- Willing to use effective birth control for the entire length of the study
Exclusion Criteria
- Diagnosed with juvenile Rheumatoid Arthritis
- Have been treated with other biologic treatment than a TNF inhibitor
- Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections
- Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization
- Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)
- Have other autoimmune disease other than RA like lupus, multiple sclerosis
- Have significant concurrent medical condition at the time of screening or baseline visit
Data sourced from ClinicalTrials.gov (NCT02638948). 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.