Phase 2
Completed N=143
Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02015520 ↗Enrolled (actual)
143
Serious AEs
1.4%
Results posted
Apr 2021
Primary outcomePrimary: Change From Baseline in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP) at Week 12 — -0.75; -1.10; -2.10; -2.43 score on a scale — p=0.38
Summary
The primary purpose of this study is to identify an appropriate dose of study medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP) at Week 12 |
-0.75; -1.10; -2.10; -2.43 | 0.38 |
| SECONDARY American College of Rheumatology (ACR) 20/50/70 Response Rates |
27.5; 14.3; 50.0; 47.5; 7.5; 14.3 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12 |
-9.9; -12.8; -17.4; -21.6 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12 |
-9.68; -13.08; -20.15; -24.02 | — |
| SECONDARY Boolean Remission at Week 12 |
5.0; 4.8; 2.4; 5.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12 |
-0.25; -0.09; -0.31; -0.46 | — |
| SECONDARY Percent of Participants With a DAS28-Erythrocyte Sedimentation Rate (ESR) <2.6 |
2.5; 4.8; 7.1; 15.0 | — |
| SECONDARY Percent of Participants With a DAS28-C Reactive Protein (CRP) <2.6 |
5.0; 9.5; 14.3; 15.0 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American Rheumatism association (ARA) [1987] or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) [2010]) at least 16 weeks prior to screening
- ACR global functional status class of 1 to 3
- Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors
- All subjects must have been receiving treatment with a minimum dose of 15 mg per week of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is permitted, if it is at a dose approved for the treatment of RA and the dose has been stable for at least 28 days prior to screening
- Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (Day 1)
- Elevated High-sensitivity (hs) CRP and/or ESR
Exclusion Criteria
- Active serious infection
- History of or active tuberculosis (TB)
- Elevated liver function tests (LFTs)
Data sourced from ClinicalTrials.gov (NCT02015520). 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.