EUCTR2006-005386-19-BE
Active, not recruiting
Phase 1
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
ConditionsRheumatoid arthritis refractory to TNF blockers patientsMedDRA version: 8.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
DrugsMabThera
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis refractory to TNF blockers patients
- Sponsor
- Cliniques Universitaires Saint-Luc
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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