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
Start and End date of grant award: Aug 2016 - Aug 2018
Current Status: recruiting
Trial unblinding information:
Monday to Friday 0900-1700 - Dr Neil McKay 0131 537 3880; Research Nurse Debbie Alexander 0131 537 3858.
Monday to Friday 0900-1800 and Saturday/Sunday 0900-1200 - Call 0131 537 1000 and ask for the on-call Rheumatologist.
All other times - emergency contact NHS 24, telephone 111. Explain that you are on a clinical trial, the doctor you see should then contact the Western General Hospital switchboard 0131 537 1000, and ask to be put through to the on call Emergency Medical Cover.
Contact details / Sponsor: AbbVie
Dept. R477, Bldg. AP4, 1 North Waukegan Road, North Chicago, IL 60064
Clinical Team: Debbie Alexander and Morag Charles
ECTU involvement: Clinical support – research nurses