A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)

Phase 3 Completed 878 enrolled Janssen Research & Development, LLC GlaxoSmithKline · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

Timeline

Start: 2012-08-06
Primary completion: 2015-03-17
Completion: 2016-01-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Sirukumab 50 mg; p < 0.001; Percentage Difference 15.9 (95% CI 8.5 to 23.2); Cochran-Mantel-Haenszel NCT01606761 ↗

registry analysis (superiority or other test); Placebo vs Sirukumab 100 mg; p < 0.001; Percentage Difference 21.0 (95% CI 13.6 to 28.5); Cochran-Mantel-Haenszel NCT01606761 ↗

release “SIRROUND-T), in patients who were refractory to or intolerant to one or more anti-tumor necrosis factor (TNF) agents, demonstrated that sirukumab met the primary endpoint” gsk.com ↗

Publications

Aletaha D, Bingham CO 3rd, Tanaka Y, Agarwal P, Kurrasch R, Tak PP, Popik S. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study. Lancet. 2017 Mar 25;389(10075):1206-1217. doi: 10.1016/S0140-6736(17)30401-4. Epub 2017 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sirukumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Sirukumab	Monoclonal antibody	100 mg	Subcutaneous