drugset / Trial / NCT01000441

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

NCT01000441

Phase 4 Completed 300 enrolled University Hospital, Strasbourg, France
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-12-23
Primary completion
2013-08-12
Completion
2013-08-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abatacept Other / unclassified
Comparator Adalimumab Monoclonal antibody
Comparator Etanercept Protein / enzyme biologic
Comparator Infliximab Monoclonal antibody
Comparator Rituximab Monoclonal antibody
Comparator Tocilizumab Monoclonal antibody

Indications