M13-545 Phase 3 JAKstudy MTX Naive subjects with Moderate to Severe RA
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 15 mg Once Daily Monotherapy,and ABT-494 30 mg Once Daily Monotherapy toMethotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis
IRAS ID
192904
Contact name
Christopher Edwards
Contact email
Sponsor organisation
AbbVie Ltd.
Eudract number
2015-003334-27
Duration of Study in the UK
1 years, 11 months, 18 days
Research summary
Rheumatoid arthritis (RA) is a lifelong disease 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 effect over the length of a patient’s life. This study is for patients with moderate to severely active RA who have not received prior Methotrexate treatment. The study is comparing ABT-494, an investigational oral drug, at two doses, high and low, with methotrexate to assess its safety and efficacy for improving the signs and symptoms of the disease; it is planned to include approximately 800 subjects at 300 sites, globally.
Each patient will undergo a screening process up to a maximum of 35 days. They will then be randomly assigned to one of 3 treatment groups (“arms”) and will enter a 52 week treatment phase with 13 clinic visits. No one involved in the studies (patients or study staff) will know to which group a patient has been assigned (“double blind”), even if it changes as outlined below. The treatment arms are ABT-494 at a high dose (1/3 of the patients assigned to this arm), ABT-494 at a low dose (1/3 of patients) and a methotrexate comparator (1/3 of patients). At week 26, patients who do not meet the required disease improvement will automatically change medication: Patients on Methotrexate will receive ABT-494 low dose, those on ABT-494 low dose will receive ABT-494 high dose and those on ABT-494 high dose will continue to receive the same treatment. There is one follow up visit 30 days after the end of treatment for all patients, and if they wish to continue or start to receive the ABT-494 medication following the treatment period, whichever arm they were in, the patients will have the option to continue into an extension study.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0700
Date of REC Opinion
25 Jan 2016
REC opinion
Further Information Favourable Opinion