| - candidate number | 2378 |
| - NTR Number | NTR851 |
| - ISRCTN | ISRCTN05568900 |
| - Date ISRCTN created | 27-jun-2007 |
| - date ISRCTN requested | 11-jun-2007 |
| - Date Registered NTR | 25-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | Prospective study on the effects of rituximab on synovial tissue of patients with rheumatoid arthritis. |
| - Scientific Title | Prospective study on the effects of rituximab on synovial tissue of patients with rheumatoid arthritis. |
| - ACRONYM | Rituximab II AMC study |
| - hypothesis | Rituximab treatment leads to a decrease in synovial B cells. The clinical response is related to the decrease in synovial B cell numbers. |
| - Healt Condition(s) or Problem(s) studied | Rheumatoid arthritis |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2005 |
| - planned closingdate | 1-mrt-2008 |
| - Target number of participants | 32 |
| - 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. Immunohistochemical analysis was performed on the synovial tissue. |
| - 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 |
| - Timepoints | |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Koen Vos |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. P.P. Tak |
| - Sponsor/Initiator | Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology |
| - Funding (Source(s) of Monetary or Material Support) | Dutch Arthritis Association (Reumafonds) |
| - Publications | N/A |
| - Brief 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 |
| - Main changes (audit trail) | |
| - RECORD | 25-dec-2006 - 3-jul-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl