Phase 2
Completed N=50
A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00550043 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Mar 2015
Primary outcomePrimary: The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement — 66.7; 16.7; 66.7; 40.0 Percentage of participants
Summary
The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Improvement |
66.7; 16.7; 66.7; 40.0; 40.0; 33.3 | — |
| SECONDARY The Percentage of Subjects Achieving ACR 50 Improvement |
88.9; 50.0; 88.9; 60.0; 50.0; 11.1 | — |
| SECONDARY The Percentage of Subjects Achieving ACR 70 Improvement |
100.0; 75.0; 100.0; 70.0; 70.0; 0.0 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 (DAS 28) ESR Score |
1.32; 2.72; 1.09; 2.53; 2.88 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 (DAS 28) CRP Score |
1.14; 2.27; 0.92; 2.33; 2.64 | — |
| SECONDARY Percentage of Subjects Who Achieved DAS 28 ESR Low Disease |
100.0; 50.0; 100.0; 90.0; 60.0; 0.0 | — |
| SECONDARY Percentage of Subjects Who Achieved DAS 28 CRP Low Disease |
100.0; 50.0; 100.0; 70.0; 50.0; 0.0 | — |
| SECONDARY Percentage of Subjects Who Achieved DAS 28 ESR Inactive Disease |
100.0; 75.0; 100.0; 100.0; 90.0; 0.0 | — |
| SECONDARY Percentage of Subjects Who Achieved DAS 28 CRP Inactive Disease |
100.0; 75.0; 100.0; 90.0; 70.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Established diagnosis of rheumatoid arthritis
- Patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry.
Exclusion Criteria
- Patients who have taken the following drugs within the timeframe below:
- Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - Within 12 weeks prior to the first dose of study medication;
- Rituximab - Within 12 months prior to the first dose of study medication;
- Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - Within 12 weeks prior to the first dose of study medication;
- Treatment with any investigational medication within 12 weeks prior to the first dose of study medication.
Data sourced from ClinicalTrials.gov (NCT00550043). 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.