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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01000441
Date of registration: 22/10/2009
Prospective Registration: Yes
Primary sponsor: University Hospital, Strasbourg, France
Public title: Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis ROC
Scientific title: Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis
Date of first enrolment: December 2009
Target sample size: 300
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01000441
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
France Monaco
Contacts
Name:     Jacques-Eric GOTTENBERG, MD, PhD
Address: 
Telephone: +0 (33) 3 88128189
Email: jacques-eric.gottenberg@chru-strasbourg.fr
Affiliation: 
Name:     Jacques-Eric GOTTENBERG, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Hôpitaux Universitaires de Strasbourg
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: abatacept, rituximab or tocilizumab
Drug: infliximab, etanercept, adalimumab
Primary Outcome(s)
Proportion of EULAR responders [Time Frame: 6 months]
Secondary Outcome(s)
Secondary ID(s)
4507
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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