Randomised study of ABT-494 in subjects with Rheumatoid Arthritis
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Phase 2 Study, to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA, Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy.
IRAS ID
141637
Contact name
David O'Reilly
Contact email
Sponsor organisation
AbbVie Inc
Eudract number
2013-002358-57
ISRCTN Number
n/a
Research summary
ABT-494 is an investigational drug that is being tested in rheumatoid arthritis (RA) patients. RA is a chronic inflammatory disease that causes changes in the lining of joints (particularly hands, wrists, feet and knees) causing them to become inflamed, stiff and painful. RA is thought to be an autoimmune disease. ABT-494 is an experimental drug that blocks the actions of proteins known as Janus kinases (Jaks). Jaks are involved in the immune response and the production of blood cells and other proteins. This study aims to find out how safe and well−tolerated ABT-494 is with multiple doses in patients with RA, and also assess how it behaves in the body and interacts with RA.
The study is double-blinded, which means neither the subject nor the study staff will know who is taking the study drug or the placebo pill. The study is placebo controlled, meaning that subjects may receive ABT-494 or a placebo (a dummy substance with identical appearance but without effective drug).
This study will last approximately 20 weeks and will include approximately 8 study visits to the hospital. There will be five groups, each group has a different dosage of the study drug or a placebo pill. Subjects will be randomly assigned by chance (like the flip of a coin) to a group. Subjects will be instructed to take two daily doses of 3 capsules (6 capsules daily) at approximately the same time each day (a.m. and p.m.) for 12 weeks.
At each session, vital signs (blood pressure, pulse rate, temperature and respiratory rate) will be checked, blood and urine samples will be taken and a questionnaire will need to be completed.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/0392
Date of REC Opinion
9 May 2014
REC opinion
Further Information Favourable Opinion