M13-542 Phase 3 ABT-494 study in Mod/Severe RA with Bio-IR
Research type
Research Study
Full title
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)
IRAS ID
188110
Contact name
Ernest Wong
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2015-003335-35
Duration of Study in the UK
4 years, 4 months, 17 days
Research summary
Research Summary
Rheumatoid arthritis (RA) is a long-lasting disease caused by an abnormal immune response predominantly affecting the joints. Patients currently have treatment options but these are not always effective. This study is for patients with moderate to severely active RA, with stable conventional synthetic Disease-Modifying AntiRheumatic Drugs (csDMARDs) and previous treatment with at least one biologic DMARD (bDMARD), experiencing an intolerance or inadequate response. The study has two parts; the first compares the investigational drug ABT-494, at high and low dose, with placebo to assess safety, effectiveness, tolerability and compare ABT-494 and placebo for the treatment of signs and symptoms of RA. The second period looks at the long term safety, effectiveness and tolerability of the two ABT-494 doses. Both include approximately 450 subjects in 300 sites globally.
Screening period is up to 35 days. If eligible, patients will be randomly assigned to one of four treatment courses; this is blinded from all involved throughout both periods of the study. The treatment courses are for ABT-494 at a high dose (1/3 of patients assigned), a low dose (1/3 of patients) and two placebo treatment courses (1/3 of patients). The first study period will consist of 24 weeks. During the first 12 weeks patients will be equally distributed to receive either low dose of ABT-494, high dose of ABT-494 or placebo. After 12 weeks, patients who received placebo will be transferred equally to either high dose or low dose of ABT-494. Patients on ABT-494 will continue at the same dose. After 24 weeks all patients will enter study period 2 and continue on the same blinded dose of ABT-494 as period 1 for 216 weeks. If a patient discontinues in either period a premature discontinuation visit is required. All patients will have a 30 day follow up visit after stopping medication.
Summary of Results
https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbX-2BuWIWNLWeNOFm9Y0auV7I3hOdsnjf6UNm1c4mWKUk9DcTG2W6hC1c2md7Y371cJw-3D-3DG4hJ_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJxASHZVxaLK6KqyKQRw7ytPBZjdoMggAi9i5zUMdJQOv-2BkpHXNrzWlsB5AVLxfjRMwmmf-2B-2BdDWu9SKUWoPEVrwWK89yCRBPSQ79jP3BZly4-2B7RdxvhugM34XVGdmvMJO9-2B8u3xGODki9LDGTqzCjIh4ZnFe5HfKbe5rgQQFZ3rug-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ce1119b5d6ce24776113308db3cbb7f50%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638170548210495094%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=P2Pji2TEUKe7ew5FFPhH5iUQDsMqdYOKhjvavo0CwO4%3D&reserved=0
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0253
Date of REC Opinion
5 Jul 2016
REC opinion
Further Information Favourable Opinion