M14-465 Phase 3 study in joint structure in Mod/Severe RA with MTX-IR
Research type
Research Study
Full title
M14-465 - A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
IRAS ID
188111
Contact name
Ernest Wong
Contact email
Sponsor organisation
Abbvie Ltd
Eudract number
2015-003333-95
Duration of Study in the UK
2 years, 4 months, 18 days
Research summary
Rheumatoid arthritis (RA) is a long-lasting disease that is caused by an abnormal immune response predominantly affecting the joints. Currently patients have a range of options for treatment but these do not always have the desired or prolonged effect over the length of a patient’s life. This study is for patients who have moderate to severely active RA and receive Methotrexate treatment but have had an inadequate response. The study is comparing ABT-494, an investigational drug, with Adalimumab and a placebo comparator whilst on a stable Methotrexate background to assess its safety, efficacy and tolerability and separately to compare ABT-494 and placebo for the structural preservation of patients’ joints. It will include approximately 1500 subjects in 370 sites globally.
Each patient will undergo a screening process up to a maximum of 35 days after which they will follow a 52 week treatment phase, with 12 clinic visits, for which the patient is randomly assigned to one of 3 treatment courses, this is blinded from all involved throughout the study even if it changes as outlined below. The treatment courses are for ABT-494 (two fifths of patients assigned), Adalimumab (one fifth of patients assigned) and placebo (two fifths of patients assigned). If patients do not meet the required disease improvement at week 14 or week 18 for patients receiving placebo and at week 24 for patients receiving Adalimumab they will start to receive ABT-494. At week 24 all remaining patients on placebo will receive ABT-494. There is a post-treatment clinic visit after 30 days and a follow up telephone call after 70 days for all patients. If they wish to continue or start to receive the ABT-494 medication following the treatment period, whichever arm they were on, the patient will have the option to continue into an extension study.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0701
Date of REC Opinion
25 Jan 2016
REC opinion
Further Information Favourable Opinion