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-* antibodies (adalimumab) or anti B cell therapy (Rituximab).

Conditions: Rheumatoid arthritis RA Vaccination
10003816
10002252
10023213

Registration Number: NL-OMON30739

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

- RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months
- Age 18-85 years
-Eligible for anti-TNF * or Rituximab therapy (according to the Dutch guidelines)

Exclusion Criteria

- Pregnancy
- Breastfeeding
- Therapy within the previous 60 days with:
*any experimental drug
*alkylating agents, e.g. cyclophosphamide, chlorambucil
*monoclonal antibodies (including infliximab and etanercept)
*growth factors
*other cytokines
- A positive PPD skin test (> 4 mm induration)
- HIV infection
- History of severe allergic or anaphylactic reactions to vaccines
- Vaccination with KLH, Pneumovax, Meningovax, Polio or tetanus toxoid in the past 12 months
- Fever (orally measured > 38 °C), chronic infections or infections requiring anti-microbial therapy
- Manifest cardiac failure (stage III or IV according to NYHA classification)
- Progressive fatal disease/terminal illness

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of patients with positive response to vaccination prior and post<br /><br>adalimumab or rituximab therapy, and measured 4 weeks after administration of<br /><br>the vaccins. Response is defined as a 2-fold increase in antibody levels to the<br /><br>administered antigens or as an absolute change in specific antibody of 1 g/mL,<br /><br>or seroconversion in patients with a non-protective baseline level of<br /><br>antibodies (<1/40).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To analyse the effect of RA disease parameters on vaccination and the influence<br /><br>of adalimumab and rituximab therapy on T and B cell response after vaccination<br /><br>as well as the relation T-B cell response.This will be done by analyzing T and<br /><br>B cell subsets, T cell cytokine production to specific antibody stimulus as<br /><br>measured by elispot and immunoglobuline subtypes.</p><br>