CompletedPhase 4

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

France300 participantsStarted 2009-12-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Proportion of EULAR responders

Timeframe: 6 months

Trial details

NCT IDNCT01000441

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08-12

View on ClinicalTrials.gov More Rheumatoid Arthritis trials