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

• Conditions: To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy

• Registration Number: EUCTR2009-016789-10-NL
• Lead Sponsor: Div KIR AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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
- Able and willing to give written informed consent
- Age 18-85 years

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

Exclusion Criteria

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
-Any concomitant medical condition which would in the investigator’s opinion compromise the patient’s ability to tolerate, absorb, metabolize or excrete the study medication.
-Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.

Exclusion criteria for healthy volunteers
- Any clinically significant medical condition

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified