Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseases
- Conditions
- Rheumatic autoimmune diseases including rheumatoid arthritis and poly or dermatomyositis.
- Registration Number
- EUCTR2008-001282-28-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
All patients and healthy controls must be:
1. 35-75 years of age
2. BMI = 18.5
3. Willing to give written informed consent
4. Diagnosed with rheumatoid arthritis according to the 1987-revised ACR-classification criteria or poly or dermatomyositis according to the criteria of Bohan and Peter.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Pregnancy
2. History of vaccination allergy
3. Known allergy to egg products
4. Positive hepatitis B serologyor denial to be tested or informed over the hepatitis B serology results
5. Rheumatic autoimmune disorder other than rheumatoid arthritis or poly or dermatomyositis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method