A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 2 Completed 187 enrolled Centocor, Inc.

RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start: 2008-08-11
Primary completion: 2011-03-03
Completion: 2011-03-03

Outcome

Met primary endpoint

paper The primary endpoint (ACR50 at week 12 in Part B) was achieved only with sirukumab 100 mg q2w versus placebo (26.7% vs 3.3%; p=0.026). PMID 24699939 ↗

Publications

Smolen JS, Weinblatt ME, Sheng S, Zhuang Y, Hsu B. Sirukumab, a human anti-interleukin-6 monoclonal antibody: a randomised, 2-part (proof-of-concept and dose-finding), phase II study in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2014 Sep;73(9):1616-25. doi: 10.1136/annrheumdis-2013-205137. Epub 2014 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sirukumab	Monoclonal antibody	25 mg	Subcutaneous
Subject	Sirukumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Sirukumab	Monoclonal antibody	100 mg	Subcutaneous
Background	Methotrexate	Small molecule	—	—