RA, reumatoide artritis, Rheumatoid Arthritis
Conditions
Interventions
All patients and volunteers will receive an A/H1N1 vaccine according to the National Guidelines. The administration of the vaccine will be coordinated by the Dutch government. Before the first vaccina
Sponsors
Academisch Medisch Centrum div. Immunology and Rheumatology
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for group A: 1. Able and willing to give written informed consent; 2. RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months; 3. Age 18-85 years; 4. Been treated with rituximab and B-cell depleted (<0.1x109/L). Inclusion criteria for group B: 1. Able and willing to give written informed consent; 2. RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months; 3. Treatment with methotrexate; 4. Age 18-85 years. Inclusion criteria for healthy volunteers: 1. Able and willing to give written informed consent; 2. Age 18-85 years.
Exclusion criteria
Exclusion criteria: Exclusion criteria for groups A and B: 1. Therapy within the previous 60 days with: A. Any experimental drug; B. Monoclonal antibodies (for group A: other than rituximab); C. Growth factors; D. Other anti-cytokines. 2. Therapy within the previous 28 days with: A. Parenteral or intra-articular corticoid injections; B. Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily. 3. Chronic infections or infections requiring anti-microbial therapy. Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus; 4. 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: 1. Any clinically significant medical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The coprimary immunogenicity end points are the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition (HI) assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer (more than 4-fold), and the factor increase in the geometric mean titer (GMT). | — |
Contacts
Public ContactP.P. Tak
Academic Medical Center (AMC), Department of Clinical Immunology and Rheumatology, P.O. Box 22660
Outcome results
None listed