Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune disorders treated with immunosuppressants.
- Conditions
- rheumatic autoimmune diseases1000381610023213
- Registration Number
- NL-OMON31399
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 120
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
- Age under 18 years
- No informed consent
- Pregnancy
- History of vaccination allergy
- Known allergy to egg products
- Patients known with positive hepatitis B serology
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Increase in titer of:<br /><br>- Haemagglutination inhibition test for influenza<br /><br>- ELISA for pneumococcal<br /><br>- ELISA for hepatitis B</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Potential adverse events<br /><br>- Disease activity</p><br>