To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy
Conditions
Interventions
Trade Name: Focetria
pandemic influenza vaccine
Pharmaceutical Form: Suspension for injection
Trade Name: Pandemrix,
Pandemic influenza vaccine
Pharmaceutical Form: Emulsion for injection
Sponsors
Div KIR AMC
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate the effect of rituximab on the efficacy of vaccination with the A/H1N1-vaccine in RA patients 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), measured 4 weeks after the last administration of the vaccine.;Secondary Objective: The secondary endpoint is to analyse the B-lymphocyte count at the same time point as the determination of the antibody titers. ;Primary end point(s): 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), measured 4 weeks after the last administration of the vaccine. | — |
Countries
Netherlands
Outcome results
None listed