M15-925 ABT-494 vs Abatacept Amendment 2.0
Research type
Research Study
Full title
A Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)
IRAS ID
217397
Contact name
Christine Murphy
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-000933-37
Duration of Study in the UK
5 years, 5 months, 3 days
Research summary
Rheumatoid arthritis (RA) is a chronic disease caused by an abnormal immune response predominantly affecting the joints. This study is for patients with moderate to severe RA, taking stable conventional rheumatoid medications. Patients should also have previous treatment with at least one biologic medication, except Abatacept, and have experienced intolerance or inadequate response. The study has two parts; the first compares the investigational drug ABT-494 with infusion of Abatacept to assess safety and effectiveness of ABT-494 whilst comparing ABT-494 and Abatacept for the treatment of signs and symptoms of RA. The second period looks at the long-term safety and effectiveness of ABT-494. The effect of the treatment on arthritis will be checked by counting swollen and tender joints, blood tests, checking for side effects and completing questionnaires. The study includes 550 subjects in 200 sites.
The screening period is up to 35 days. If eligible, patients will be randomly assigned to either ABT-494 or Abatacept. This is blinded from all involved through period 1 which is 24 weeks long. Half of the patients will take ABT-494 daily and half will receive Abatacept infused on Day 1, Week 2, 4, 8, 12, 16 and 20. Patients will take matching placebo to maintain blinding. After 24 weeks, patients enter period 2, which is un-blinded. Patients taking Abatacept will be transitioned onto ABT-494 and patients taking ABT-494 will continue on this treatment in period 2 for 92 weeks. If there is inadequate disease control, then background medications can be adjusted or patient can stop study drug and be treated at the physician’s judgment. If a patient discontinues in either period, a discontinuation visit is required. Patients will have a 70 day follow up after stopping medication in Period 1 and a 30 day follow up visit after stopping medication in Period 2.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0082
Date of REC Opinion
27 Apr 2017
REC opinion
Further Information Favourable Opinion