A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Summary

The primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.

Timeline

Start

2014-04-04

Primary completion

2016-08-17

Completion

2016-08-17

Outcome

Mixed primary results

registry analysis (superiority or other test); Adalimumab 40 mg vs Sirukumab 100 mg; p < 0.001; LS mean difference -0.76 (95% CI -1.07 to -0.46); ANCOVA NCT02019472 ↗

registry analysis (superiority or other test); Adalimumab 40 mg vs Sirukumab 50 mg; p =0.013; Least Square (LS) mean difference -0.39 (95% CI -0.69 to -0.08); ANCOVA NCT02019472 ↗

registry analysis (superiority or other test); Adalimumab 40 mg vs Sirukumab 50 mg; p = 0.306; Percentage Difference -4.8 (95% CI -14.1 to 4.4); Cochran-Mantel-Haenszel NCT02019472 ↗

registry analysis (superiority or other test); Adalimumab 40 mg vs Sirukumab 100 mg; p = 0.464; Percentage Difference 3.6 (95% CI -6 to 13.1); Cochran-Mantel-Haenszel NCT02019472 ↗

Publications

• Taylor PC, Schiff MH, Wang Q, Jiang Y, Zhuang Y, Kurrasch R, Daga S, Rao R, Tak PP, Hsu B. Efficacy and safety of monotherapy with sirukumab compared with adalimumab monotherapy in biologic-naive patients with active rheumatoid arthritis (SIRROUND-H): a randomised, double-blind, parallel-group, multinational, 52-week, phase 3 study. Ann Rheum Dis. 2018 May;77(5):658-666. doi: 10.1136/annrheumdis-2017-212496. Epub 2018 Feb 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Sirukumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Sirukumab	Monoclonal antibody	100 mg	Subcutaneous

Indications