ESRA onderzoek.
Completed
- Conditions
- RA, reumatoide artritis, Rheumatoid Arthritis
- Registration Number
- NL-OMON28264
- Lead Sponsor
- Academisch Medisch Centrum div. Immunology and Rheumatology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
Inclusion criteria for group A:
1. Able and willing to give written informed consent;
Exclusion Criteria
Exclusion criteria for groups A and B:
1. Therapy within the previous 60 days with:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method