A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)

Phase 3 Completed 1670 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) and inhibition of radiographic progression in patients with active RA who are unresponsive to treatment with disease-modifying antirheumatic drugs (DMARD).

Timeline

Start: 2012-08-15
Primary completion: 2015-09-02
Completion: 2016-12-06

Outcome

Met primary endpoint

registry NUMBER Placebo: 26.4 Percentage of Participants NUMBER Sirukumab 50 mg: 54.8 Percentage of Participants NCT01604343 ↗

registry Placebo vs Sirukumab 50 mg; p < 0.001; Percentage Difference 28.4 (95% CI 22.8 to 33.8); Cochran-Mantel-Haenszel NCT01604343 ↗

registry Placebo vs Sirukumab 50 mg; p < 0.001; van der waerden ANOVA NCT01604343 ↗

release “The SIRROUND-D study met both co-primary endpoints” jnj.com ↗

Publications

Takeuchi T, Thorne C, Karpouzas G, Sheng S, Xu W, Rao R, Fei K, Hsu B, Tak PP. Sirukumab for rheumatoid arthritis: the phase III SIRROUND-D study. Ann Rheum Dis. 2017 Dec;76(12):2001-2008. doi: 10.1136/annrheumdis-2017-211328. Epub 2017 Aug 30.

Drugs

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