Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate

Summary

Study in participants with RA who have an inadequate response to methotrexate.

Timeline

Start

2009-12-30

Primary completion

2011-02-11

Completion

2011-02-11

Outcome

Missed primary endpoint

registry Placebo vs Brodalumab 70 mg; p = 0.598; Difference in response rate 3.2 (95% CI -9.0 to 15.4) NCT00950989 ↗

registry Placebo vs Brodalumab 210 mg; p = 0.572; Difference in response rate -3.2 (95% CI -14.1 to 7.8) NCT00950989 ↗

Publications

• Background Pavelka K, Chon Y, Newmark R, Lin SL, Baumgartner S, Erondu N. A study to evaluate the safety, tolerability, and efficacy of brodalumab in subjects with rheumatoid arthritis and an inadequate response to methotrexate. J Rheumatol. 2015 Jun;42(6):912-9. doi: 10.3899/jrheum.141271. Epub 2015 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brodalumab	Monoclonal antibody	70 mg	Subcutaneous
Subject	Brodalumab	Monoclonal antibody	140 mg	Subcutaneous
Subject	Brodalumab	Monoclonal antibody	210 mg	Subcutaneous
Background	Methotrexate	Small molecule	—	—

Indications