AbbVie M13-542

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

To compare the safety and efficacy of ABT-494 30 mg once daily (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-intolerant subjects with moderately to severely active RA.

 

Chief Investigator: Dr Neil McKay

Number and location of participating sites (by region/ country): International multicentre trial approx. 300

EudraCT number: 2015-003335-35

 

Funder: AbbVie

Start and End date of grant award: Aug 2016 - Aug 2018

 

Current Status: recruiting                           

Contact details / Sponsor: AbbVie

Dept. R477, Bldg. AP4, 1 North Waukegan Road, North Chicago, IL 60064

 

ECTU involvement: Clinical support – research nurses