Rituximab treatment leads to a decrease in synovial B cells. The clinical response is related to the decrease in synovial B cell numbers.
ID
Bron
Verkorte titel
Aandoening
rheumatoid arthritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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
Doel van het onderzoek
Rituximab treatment leads to a decrease in synovial B cells. The clinical response is related to the decrease in synovial B cell numbers.
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Previous treatment with rituximab;
2. Intra-articular or parenteral corticosteroids within 4 weeks prior to inclusion.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL837 |
| NTR-old | NTR851 |
| Ander register | : N/A |
| ISRCTN | ISRCTN05568900 |