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Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune disorders treated with immunosuppressants.

Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune disorders treated with immunosuppressants. - n.v.t.

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON31399
Enrollment
120
Registered
2007-10-25
Start date
2007-10-01
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

rheumatic autoimmune diseases

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In general: willing to give written informed consent. Per group: 1. Patients with rheumatic autoimmune diseases, including rheumatoid arthritis, poly or dermatomyositis, systemic lupus erythematosus, Sjögren*s syndrome, treated with rituximab within 3-9 months prior to start of the study with or without concomitant treatment with traditional DMARDs and/or corticosteroids. 2. Patients with rheumatic autoimmune diseases, including rheumatoid arthritis, poly or dermatomyositis, systemic lupus erythematosus, Sjögren*s syndrome, treated with TNFa blocking agents as single therapy or combined with DMARDs and/or corticosteroids on stable therapy of 3 or more months. 3. Patients with rheumatic autoimmune disease, including rheumatoid arthritis, poly or dermatomyositis, systemic lupus erythematosus, Sjögren*s syndrome, on stable therapy with only traditional DMARDs and/or corticosteroids for 3 or more months. 4. Age and gender matched healthy controls

Exclusion criteria

Exclusion criteria: - Age under 18 years - No informed consent - Pregnancy - History of vaccination allergy - Known allergy to egg products - Patients known with positive hepatitis B serology

Design outcomes

Primary

MeasureTime frame
Increase in titer of: - Haemagglutination inhibition test for influenza - ELISA for pneumococcal - ELISA for hepatitis B

Secondary

MeasureTime frame
- Potential adverse events - Disease activity

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)