An open-label pilot study on the effects of trivalent inactivated influenza vaccination (Influvac®) in rheumatoid arthritis patients treated with rituximab

An open-label pilot study on the effects of trivalent inactivated influenza vaccination (Influvac®) in rheumatoid arthritis patients treated with rituximab - Influenza vaccination in RA patients treated with rituximab

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30994

Enrollment

Registered

2007-08-10

Start date

2007-09-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Rheumatoid arthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients have to fulfil the diagnostic criteria for RA as defined by the ACR9 - group I: treatment with rituximab (according to RA scheme), in combination with methotrexate, started 4 weeks before inclusion - group II: treatment with rituximab (according to RA scheme) started 6-9 months before inclusion - group III: second or third treatment with rituximab (according to RA scheme), in combination with methotrexate, started 4 weeks before inclusion - group IV: treatment with monotherapy methotrexate - informed consent

Exclusion criteria

Exclusion criteria: - age under 18 years - current infection, defined as fever in combination with clinical focal signs of infection and the need for therapeutic antibiotic treatment - pregnancy - malignancy - known allergy to or former severe reaction following Influvac®

Design outcomes

Primary

Measure	Time frame
Humoral and cellular immunity against the in the vaccin included antigens by: * Haemagglutinin Inhibition Assay (HAI) * IFN-gamma and IL-4 Enzyme Linked Immunospotting (ELISPOT) * Intracellular Cytokine Staining and Fluorescence-activated cell sorting (ICC & FACS) * Assessment of proliferation of CD4 and CD8 T cells using CFSE dye dilution and analysis by Flow Cytometry	—

Secondary

Measure	Time frame
- Side effects	—

Countries

Netherlands

Outcome results