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

NCT01000441

CompletedPhase 4

Sponsor: University Hospital, Strasbourg, France

Conditions: Rheumatoid Arthritis

Interventions: infliximab, etanercept, adalimumab, abatacept, rituximab or tocilizumab

Countries: France, Monaco

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (44)
  • Amiens, France
  • Belfort, France
  • Besançon, France
  • Bondy, France
  • Bordeaux, France
  • Boulogne-Billancourt, France
  • Brest, France
  • Caen, France
  • Cahors, France
  • Cannes, France
  • Clermont-Ferrand, France
  • Colmar, France
  • Grenoble, France
  • La Roche-sur-Yon, France
  • Le Havre, France
  • Le Kremlin-Bicêtre, France
  • Le Mans, France
  • Liévin, France
  • Lille, France
  • Limoges, France
  • Lomme, France
  • Marseille, France
  • Montpellier, France
  • Montpellier, France
  • Mulhouse, France
  • Nantes, France
  • Nice, France
  • Orléans, France
  • Paris, France
  • Paris, France
  • + 14 more on CT.gov