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).

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). - SEVRA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30739

Enrollment

Registered

2007-07-12

Start date

2006-11-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis RA Vaccination

Interventions

All patients will receive 2 sets of vaccines. The first set 4 weeks prior the initiation of anti-TNFalpha or Rituximab therapy, the second set 6 weeks after initiation of the therapy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 (	—

Secondary

Measure	Time frame
To analyse the effect of RA disease parameters on vaccination 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 as measured by elispot and immunoglobuline subtypes.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)