No registrations found.
ID
Source
Brief title
Health condition
rheumatoid arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
This open label study will include patients with active rheumatoid arthritis. Before and 4 and 16 weeks after treatment with rituximab (2 infusions with 1000 mg rituximab without premedication with corticosteroids), synovial biopsies will be taken with a mini-arthroscopy from a clinically inflamed joint. The same joint will be used for each arthroscopy. Immunohistochemical analysis of synovial tissue will be performed using digital image analysis. Clinical features like disease activity using the DAS28 will be measured regularly. At different time points the number of B cells will be measured in peripheral blood by FACS analysis
Study objective
Rituximab treatment leads to a decrease in synovial B cells. The clinical response is related to the decrease in synovial B cell numbers.
Intervention
The patients underwent an arthroscopic synovial biopsy procedure directly before and 4 and 16 weeks after receiving two infusions of rituximab without methylprednisolone premedication. Immunohistochemical analysis was performed on the synovial tissue.
Clinical Immunology and Rheumatology
P.O. Box 22660
Koen Vos
Address Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
K.Vos@amc.uva.nl
Clinical Immunology and Rheumatology
P.O. Box 22660
Koen Vos
Address Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
K.Vos@amc.uva.nl
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
1. Previous treatment with rituximab;
2. Intra-articular or parenteral corticosteroids within 4 weeks prior to inclusion.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL837 |
| NTR-old | NTR851 |
| Other | : N/A |
| ISRCTN | ISRCTN05568900 |