Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Phase 2/3 Completed 302 enrolled Abbott

RandomizedParallel-groupTriple-blindTreatment

Summary

A study to assess the safety and efficacy of adalimumab administered as a subcutaneous injection in adult Chinese subjects with rheumatoid arthritis and treated with methotrexate

Timeline

Start: 2007-08
Primary completion: 2008-07
Completion: 2009-12

Outcome

Met primary endpoint

registry Placebo vs Adalimumab 80 mg; p = 0.026; Odds Ratio (OR) 2.19 (95% CI 1.09 to 4.39) NCT00538902 ↗

registry Placebo vs Adalimumab 40 mg; p = 0.004; Odds Ratio (OR) 2.68 (95% CI 1.35 to 5.30) NCT00538902 ↗

Publications

Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Adalimumab	Monoclonal antibody	80 mg	Subcutaneous