Prospective study on the effects of rituximab on synovial tissue of patients with rheumatoid arthritis
| ISRCTN | ISRCTN05568900 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05568900 |
| Protocol serial number | NTR851 |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | Dutch Arthritis Association (Reumafonds) (The Netherlands) |
- Submission date
- 27/06/2007
- Registration date
- 27/06/2007
- Last edited
- 03/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Academic Medical Centre (AMC)
Department of Medicine
Division of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 2171 |
|---|---|
| K.Vos@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective open-labelled study |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study acronym | Rituximab II AMC study |
| Study objectives | Rituximab treatment leads to a decrease in synovial B cells. The clinical response is related to the decrease in synovial B cell numbers. |
| Ethics approval(s) | Received from the Medical Ethics Committee of the Academic Medical Center, University of Amsterdam on the 25th March 2005 (ref: 05/038). |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rituximab |
| Primary outcome measure(s) |
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 analysed by digital image analysis. Statistical analysis is performed to find predictors of clinical response after 24 weeks. |
| Key secondary outcome measure(s) |
1. To study the safety and effectivity of a fixed rituximab retreatment protocol |
| Completion date | 01/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 32 |
| Key inclusion criteria | 1. Patients (18 years or older) with rheumatoid arthritis (American College of Rheumatology [ACR] 1987 criteria) with active disease (at least 4/28 swollen and at least 4/28 painful joints, and either Erythrocyte Sedimentation Rate [ESR] 28 mm or C-Reactive Protein [CRP] 15 mg/l or morning stiffness for 45 minutes) 2. Rheumatoid factor and/or anti-Cyclic Citrullinated Peptide antibody (anti-CCP) positive 3. Stable doses of methotrexate (5 - 30 mg) 4. Stable doses of prednisone (0 - 10 mg) 5. Previous anti-Tumour Necrosis Factor (anti-TNF) treatment is allowed |
| Key exclusion criteria | 1. Previous treatment with rituximab 2. Intra-articular or parenteral corticosteroids within four weeks prior to inclusion |
| Date of first enrolment | 01/03/2005 |
| Date of final enrolment | 01/03/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2008 | Yes | No |
