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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00731965 |
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Date of registration:
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06/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Juvenile Idiopathic Arthritis
VAART |
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Scientific title:
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Multicenter Randomized Clinical Trial in Patients With Juvenile Idiopathic Arthritis: Safety and Efficacy of Vaccination With Live Attenuated Measles, Mumps, Rubella Vaccine |
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Date of first enrolment:
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May 2008 |
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Target sample size:
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140 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00731965 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Nico M. Wulffraat, MD;PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UMC Utrecht |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- all subtypes of JIA according to ILAR criteria
- ages 4 to 9 (before the scheduled booster, normally administered at age 9 in the
Netherlands)
- 5 healthy adults (aged 18 to 65y)
Exclusion Criteria:
- use of Infliximab (Remicade, anti-Tumor Necrosis Factor (TNF) alpha therapy).
- primary immunodeficiency
- fever less than 48 hour prior to vaccination (vaccination will be postponed for 1
month)
- evidence of viral or bacterial infection less than 48hours prior to vaccination
(vaccination will be postponed for 1 month)
- methylprednisolone pulse therapy less than 1 month prior to vaccination (vaccination
will be postponed for 1 month)
- transfusion of blood or blood products (e.g. intravenous immunoglobulins (IVIG)) in
the 3 months prior to vaccination (vaccination will be postponed for 3 months)
Age minimum:
4 Years
Age maximum:
9 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Arthritis, Juvenile Rheumatoid
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Intervention(s)
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Biological: Measles, Mumps, Rubella vaccination
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Primary Outcome(s)
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JIA disease activity, defined by the core set criteria for JIA and number of flares
[Time Frame: baseline and after 3, 6,9,12 months]
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Secondary Outcome(s)
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Immunological reaction to MMR vaccination and regulatory mechanisms induced by MMR, measured by number and function of MMR-specific T cells and cytokine profiles
[Time Frame: baseline, 3 and 12 months]
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Secondary ID(s)
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ISRCTN12271664
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VAART
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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