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ESRA onderzoek.


- candidate number8289
- NTR NumberNTR2445
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-aug-2010
- Secondary IDs09/312 / 2009-016789-10 ; MEC AMC / EUdraCT
- Public TitleESRA onderzoek.
- Scientific TitleEfficacy of the H1N1 Flu (Swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab.
- ACRONYMESRA trial
- hypothesisSince previous studies suggest that an influenza vaccination is probably less or even not effective in rituximab treated RA patients, we want to investigate if this also holds true for this new vaccine against the H1N1 virus.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteriaInclusion 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 criteriaExclusion 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 16-nov-2009
- planned closingdate1-sep-2010
- Target number of participants45
- InterventionsAll 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 vaccination and 4 weeks after the second vaccination serum samples will be collected and B-lymphocyte counts will be assessed. Functional tests on the isolated B- and T lymphocytes will be performed.
- Primary outcomeThe 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 outcomeN/A
- TimepointsPrior to vaccine administration and 4 weeks after second vaccination.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD2-aug-2010 - 14-aug-2010


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