Influenza vaccination in patients with systemic lupus erythematosus and Wegener's granulomatosis.
Completed
- Conditions
- 1. Systemic lupus erythematosus<br />2. Wegener's granulomatosis.
- Registration Number
- NL-OMON25590
- Lead Sponsor
- niversity Medical Center Groningen, the Netherlands
- Brief Summary
Ann Rheum Dis. 2008 Jul 14. [Epub ahead of print].
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
Inclusion Criteria
1. Patients have to fulfil international disease criteria of SLE or WG;
2. quiescent disease, defined as SLEDAI under 6 or BVAS under 2;
Exclusion Criteria
SLE patients are not eligible for the study in case of:
1. active disease, defined as SLEDAI >5;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antibody response to vaccination:<br /> seroprotection rate, fourfold titre rises and geometric mean titres.
- Secondary Outcome Measures
Name Time Method 1. safety: changes in disease activity in terms of SLEDAI (systemic lupus erythematosus) or BVAS (Wegener's granulomatosis).<br><br>2. Effect of immunosuppressive drugs on antibody responses to vaccination<br><br>3. cell-mediated responses to influenza (vaccination)