Rheumatoid arthritis refractory to TNF blockers patients MedDRA version: 8.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Trade Name: MabThera
Pharmaceutical Form: Solution for infusion
Sponsors
Cliniques Universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of Rituximab on synovial histology and gene expression in severe rheumatoid arthritis refractory to TNF blockers. ;Secondary Objective: The secondary endpoints of the study are as follows: 1. To confirm the clinical efficacy of Rituximab in this population. 2. To evaluate the safety profile of Rituximab. ;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). | — |
Countries
Belgium
Outcome results
None listed