Phase 2
Completed N=187
A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00718718 ↗
Enrolled (actual)
187
Serious AEs
7.3%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) — 3.3; 26.7; 23.3; 26.7 Percentage of Participants — p=0.026
Summary
The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) |
3.3; 26.7; 23.3; 26.7; 19.4 | 0.026 sig |
| SECONDARY Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) |
6.341; 5.919; 5.908; 5.755; 6.190; 6.051 | < 0.001 sig |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A) |
5.9; 28.6 | 0.148 |
| SECONDARY Serum Sirukumab Concentrations Through Week 38 (Part A) |
NA; 0.01; NA; 3.73; NA; 7.40 | — |
| SECONDARY Serum Sirukumab Concentrations Through Week 38 (Part B) |
NA; 0.03; 0.00; 0.02; 0.01; NA | — |
| SECONDARY Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) |
-49.31; 81.46; 88.53; 85.42; 81.22; 19.97 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with rheumatoid arthritis (RA) for at least 4 months prior to screening
- Have been treated and having an inadequate response with the tolerated dose of methotrexate (MTX) (at least 15mg/week) for at least 4 months prior to screening. MTX doses of 10 or 12.5 mg/week are allowed if participant had intolerance of 15 mg/week
- MTX route of administration and dose (not to exceed 25 mg/week) should be stable for at least 6 weeks prior to the start of the study medication
- Have active RA as defined by persistent disease activity with at least 6 swollen and 6 tender joints, at the time of screening and baseline, and either anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive at screening
- C-reactive protein greater than or equal to 1.0 mg/dL (10 mg/L)
- Agree to use one of the contraception methods defined in the protocol
Exclusion Criteria
- Have inflammatory diseases other than RA that might confound the evaluation of the benefit of CNTO 136 therapy in arthritis
- Family history of/ have long QT syndrome; or a history of second or third-degree heart block
- Received systemic immunosuppressives or disease modifying antirheumatic drug other than MTX, sulfasalazine, hydroxychloroquine or chloroquine within 4 weeks prior to the start of study medication
- Received intra articular (into joints), intramuscular, or intravenous corticosteroids within 4 weeks prior to the start of study medication
- Positive human immunodeficiency virus test, hepatitis B or hepatitis C
- History of / have chronic or recurrent infectious disease, history of / active tuberculosis
- Have serious infection within 2 months prior to start of study medication
Data sourced from ClinicalTrials.gov (NCT00718718). 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.