Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
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...
Brief Summary
Official Title: “Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2012
Intervention(s) in this Clinical Trial
- Drug: infliximab, etanercept, adalimumab
- Drug: abatacept, rituximab or tocilizumab
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: arm 1 (2d anti-TNF):
- infliximab, etanercept, adalimumab
- Active Comparator: arm 2 (other biotherapy)
- abatacept, rituximab or tocilizumab
Outcome Measures for this Clinical Trial
Primary Measures
- Proportion of EULAR responders
- Time Frame: 6 months
Safety Issue?: No
- Time Frame: 6 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University Hospital, Strasbourg, France Other
Overall Clinical Trial Officials and Contacts
Jacques-Eric GOTTENBERG, MD, PhD Principal Investigator Hôpitaux Universitaires de Strasbourg
Overall Contact: Jacques-Eric GOTTENBERG, MD, PhD +0 (33) 3 88128189 jacques-eric.gottenberg@chru-strasbourg.fr
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01000441
Study ID Number: 4507
ClinicalTrials.gov Identifier: NCT01000441
Health Authority: France: Afssaps - French Health Products Safety Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01000441
