Prospective study on the effects of rituximab on synovial tissue of patients with rheumatoid arthritis.

Completed

Conditions: rheumatoid arthritis

Registration Number: NL-OMON19978

Lead Sponsor: Academic Medical Center/University of Amsterdam

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the synovial tissue response to rituximab treatment and to identify possible predictors of clinical response in patients with rheumatoid arthritis (RA).<br>RA patients undergo synovial biopsy before, 4 and 16 weeks after <br>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.<br><br>

Secondary Outcome Measures

Name	Time	Method
1. To study the safety and effectivity of a fixed rituximab retreatment protocol;<br>2. To study influence of rituximab on anti-drug antibody formation;<br>3. To explore pharmacokinetic and pharmacodynamc effects in blood and <br>synovial tissue<br>