Status:
COMPLETED
Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)
Lead Sponsor:
University Hospital, Tours
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Rituximab, an anti CD-20 monoclonal antibody targeting B lymphocytes is prescribed in rheumatoid arthritis (RA) patients refractory to TNF alpha antagonists. According to previous studies, 25 to 50% o...
Detailed Description
Rituximab, an anti CD-20 monoclonal antibody targeting B lymphocytes is prescribed in rheumatoid arthritis (RA) patients refractory to TNF alpha antagonists. According to previous studies, (Edwards, S...
Eligibility Criteria
Inclusion
- RA according to the American College of Rheumatology (ACR) criteria
- Treatment with adalimumab in accordance to the SPC
- Disease modifying anti rheumatic drugs (DMARDs) stable 4 weeks before enrollment and during 16 weeks.
- Signed consent
Exclusion
- No anti TNF-alpha failure or contraindication
- Previous adalimumab treatment
- Contraindication to adalimumab, methylprednisolone or methotrexate (when used in combination with adalimumab)
- methotrexate-naive patient
- Any hematologic disease affecting the lymphocytes (in particular lymphomas)
- Any osteo-articular disease which could interfere with the interpretation of the influence of the rituximab on RA
Key Trial Info
Start Date :
March 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02304354
Start Date
March 9 2015
End Date
December 18 2019
Last Update
May 6 2021
Active Locations (8)
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1
Rhumatologie, CHRU de BREST
Brest, France, 29609
2
Rhumatologie, CHD LA ROCHE SUR YON
La Roche-sur-Yon, France, 85925
3
Rhumatologie, CHR du MANS
Le Mans, France, 72037
4
Rhumatologie, CHRU de NANTES
Nantes, France, 44093