AbbVie M13-549

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

To compare the efficacy of ABT-494 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of subjects with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response to csDMARDs.

To compare the safety and tolerability of ABT-494 30 mg QD and 15 mg QD versus placebo in subjects with moderately to severely active RA who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs.

To evaluate the long-term safety, tolerability, and efficacy of ABT-494 30 mg QD and 15 mg QD in subjects with RA who have completed Period 1.

Chief Investigator: Dr Neil McKay

Number and location of participating sites (by region/ country): multicentre

EudraCT number: 2015-003332-13

Funder: AbbVie

Start and End date

Of grant award November 2016- March 2019

Current Status: Recruitment complete – in follow up

Trial Unblinding Information: In circumstances where unblinding is necessary please refer to the protocol and follow instructions provided. Contact details are provided below.

Contact details:

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

Research nurses: Kate Covil/Debbie Alexander

ECTU involvement: clinical support - research nurses