Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab

Div KIR AMC0 sitesNovember 17, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy
Sponsor: Div KIR AMC
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

November 17, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Div KIR AMC

•Inclusion criteria for group A
•\-Able and willing to give written informed consent
•\-RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months
•\-Age 18\-85 years
•\-Been treated with rituximab and B\-cell depleted (\<0\.1x109/L)
•Inclusion criteria for group B
•\- Able and willing to give written informed consent
•\-RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months
•\- Age 18\-85 years
•Inclusion criteria for healthy volunteers

•Exclusion criteria for group A and B
•\-Therapy within the previous 60 days with:
•any experimental drug
•monoclonal antibodies ( for group A: other than rituximab)
•growth factors
•other anti\-cytokines
•\-Therapy within the previous 28 days with:
•parenteral or intra\-articular corticoid injections
•oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily
•\-Chronic infections or infections requiring anti\-microbial therapy. Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus