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

Sponsor
University Hospital, Strasbourg, France
Study ID
NCT01000441
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 23, 2009
Status verified
Jan 2026
Primary completion
Aug 12, 2013
Completion
Aug 12, 2013

Study Design

Enrollment
300 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: arm 1 (2d anti-TNF):
    infliximab, etanercept, adalimumab
  • Active Comparator: arm 2 (other biotherapy)
    abatacept, rituximab or tocilizumab

Primary Outcome Measure

Proportion of EULAR responders [ Time Frame: 6 months ]

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