Influenza Clinical Trial
Official title:
Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory Drugs
The spread of Influenza H1N1 has prompted the development of vaccines against this virus. Immunocompromised patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients.
100 patients with Rheumatoid Arthritis (RA), 50 patients with Systemic Lupus Erythematosus
(SLE), 50 patients with spondyloarthropathies (Psoriatic arthritis (PsA) and Ankylosing
Spondylitis (AS) and 200 healthy subjects will participate in the study.
All the subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day
of vaccination and 4 weeks later.
The evaluation will include:
Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the
presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test.
Safety of the vaccine:
- Records of adverse event
- Assessment of disease activity : RA - Disease activity score (DAS 28), SLE - SLEDAI,
PsA - DAS 28 and PASI, AS- BASDAI, ESR, CRP
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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