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

Div KIR AMC0 个研究点开始时间: 2009年11月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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 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

发起方

Div KIR AMC