Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini

Phase 1

• Conditions: Rheumatoid arthritis refractory to TNF blockers patients; MedDRA version: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

• Registration Number: EUCTR2006-005386-19-BE
• Lead Sponsor: Cliniques Universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-03
• Study Completion: 2008-12-24
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Diagnosis of RA (according to ACR criteria)
Active RA defined by a DAS28-CRP score > 5.1 or >3.2 with a swollen joint count = 8
Presence of knee arthralgia or synovitis
Failure to at least one TNF blocker (Remicade, Enbrel, Humira)
Stable therapy with MTX, corticosteroïds or NSAIDs

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous Rituximab treatment
Exclusion for general safety (history of severe allergic reaction, sepsis, malignancy within 5 years, pregnancy, severe heart failure)

Excluded Concomitant Medications :
Concurrent treatment with other DMARDs than MTX or any anti-TNF and biological therapies. Enbrel, Remicade and Humira should be respectively stopped 4, 8 and 8 weeks before inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of Rituximab on synovial histology and gene expression in severe rheumatoid arthritis refractory to TNF blockers.<br>;Secondary Objective: The secondary endpoints of the study are as follows:<br><br>1.To confirm the clinical efficacy of Rituximab in this population. <br>2.To evaluate the safety profile of Rituximab.<br>;Primary end point(s): to evaluate the synovitis histopathological findings in a small group of RA patients refractory to TNF blockers treated with 2 doses of Rituximab (1 gr 2 weeks apart).