rheumatoid arthritis
Conditions
Interventions
The patients underwent an arthroscopic synovial biopsy procedure directly before and 4 and 16 weeks after receiving two infusions of rituximab without methylprednisolone premedication. Immunohistochem
Sponsors
Academic Medical Center/University of Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients (18 years or older) with rheumatoid arthritis (ACR 1987 criteria) with active disease (at least 4/28 swollen and at least 4/28 painfull joints, and either ESR 28 mm or CRP 15 mg/l or morning stiffness 45 min); 2. Rheumatoid factor and/or anti-CCP positive; 3. Stable doses methotrexate (5-30 mg); 4. Stable doses prednisone (0-10 mg); 5. Previous anti-TNF treatment is allowed.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with rituximab; 2. Intra-articular or parenteral corticosteroids within 4 weeks prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the synovial tissue response to rituximab treatment and to identify possible predictors of clinical response in patients with rheumatoid arthritis (RA). RA patients undergo synovial biopsy before, 4 and 16 weeks after initiation of rituximab treatment without peri-infusional corticosteroids. Immunohistochemical analysis is performed and stained sections are analyzed by digital image analysis. Statistical analysis is performed to find predictors of clinical response after 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the safety and effectivity of a fixed rituximab retreatment protocol; 2. To study influence of rituximab on anti-drug antibody formation; 3. To explore pharmacokinetic and pharmacodynamc effects in blood and synovial tissue | — |
Contacts
Public ContactKoen Vos
Academic Medical Center (AMC), Department of Medicine, Division of Clinical Immunology and Rheumatology P.O. Box 22660
Outcome results
None listed