Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2013-08-12
• Target enrollment: 0
• Participant gender: All

Summary

Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Abatacept; Adalimumab; Etanercept; Infliximab; Rituximab

Criteria

Inclusion Criteria:

• Active and erosive rheumatoid arthritis with a DAS28 equal or greater than 3.2

• Inadequate response to a 1st anti-TNF

• Stable or no treatment with any DMARDs, or oral corticosteroids (< or = to 10 mg/day of prednisone equivalent)during the preceding month

Exclusion Criteria:

• Counter-indication to other anti-TNF, abatacept, rituximab or tocilizumab

• Pregnancy

• Age < 18 years

• Impossibility to give informed consent

• Impossibility to be followed for 12 months