Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)

• Status: Completed
• Trial end date: 2019-12-18
• Target enrollment: 0
• Participant gender: All

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% of patients have an insufficient or absence of response to rituximab at week 24.

In a recent retrospective study, a CD4+ T-lymphocytes depletion was observed after a first course of rituximab in RA patients. The absolute CD4+ number at week 12 was 37% (±33) of the baseline value, leading to < 200 cells/µL in 5% of patients. Interestingly the absence of CD4+ T-lymphocytes depletion was observed in clinical non-responders, suggesting the involvement of T-lymphocytes in the mechanism of action of rituximab. So far no prospective study have supported the usefulness of lymphocyte phenotyping, in particular T-lymphocytes, to monitor rituximab-treated RA patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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