SEVRA-TRIAL Safety and efficacy of vaccination with T cell-dependent and T cell-independent primary and recall antigens in patients with rheumatoid arthritis treated with anti TNF-á antibodies (adalimumab) and anti B cell therapy (Rituximab).
Recruiting
- Conditions
- Rheumatoid arthritis.
- Registration Number
- NL-OMON25723
- Lead Sponsor
- Philip Remans, MD,PhD, Division of Clinical Immunology and Rheumatology, Hans Schipper, MD, PhD, Department of Internal Medicin, Theo Out, PhD, laboratory of Medical Immunology, René Lutter, PhD, Department of Experimental immunology, Ruth klaasen, MD, Division of Clinical Immunology and Rheumatology, Danielle Gerlag, MD, Division of Clinical Immunology and Rheumatology, Paul P. Tak, MD, PhD, Professor of Medicine.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Able and willing to give written informed consent;
2. A diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months;
Exclusion Criteria
1. A positive PPD skin test (> 4 mm induration);
2. Pregnancy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with positive response to vaccination prior and post adalimumab or rituximab therapy, and measured 4 weeks after administration of the vaccins. Response is defined as a 2-fold increase in antibody levels to the administered antigens or as an absolute change in specific antibody of 1 g/mL, or seroconversion in patients with a non-protective baseline level of antibodies (<1/40).
- Secondary Outcome Measures
Name Time Method To analyse the effect of vaccination on RA disease parameters and the influence of adalimumab and rituximab therapy on T and B cell response after vaccination, as well as the relation T-B cell response. This will be done by analyzing T and B cell subsets, T cell cytokine production to specific antibody stimulus measured by elispot and immunoglobuline subtypes.