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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR851
• Date of registration: 25/12/2006
• Primary sponsor: Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
• 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. - Rituximab II AMC study
• Date of first enrolment: 1/3/2005
• Target sample size: 32
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=851
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: P.P. Tak

• Name: Koen Vos

Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis

Intervention(s)

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(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 analyzed by digital image analysis. Statistical analysis is performed to find predictors of clinical response after 24 weeks.

Secondary Outcome(s)

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

Secondary ID(s)

ISRCTN05568900

N/A

Source(s) of Monetary Support

Dutch Arthritis Association (Reumafonds)