Status:
COMPLETED
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Juvenile Idiopathic Arthritis
Lead Sponsor:
N.M. Wulffraat
Collaborating Sponsors:
University Medical Center Groningen
Amsterdam UMC, location VUmc
Conditions:
Arthritis, Juvenile Rheumatoid
Eligibility:
All Genders
4-9 years
Phase:
PHASE4
Brief Summary
Background: The safety of vaccination in patients with autoimmune diseases using immune suppressive therapy is often discussed. Previous studies in Juvenile Idiopathic Arthritis (JIA) patients showed...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00731965
Start Date
May 1 2008
End Date
May 1 2012
Last Update
July 30 2014
Active Locations (5)
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1
Academic hospital Maastricht
Maastricht, Limburg, Netherlands, 6202 AZ
2
University Medical Center Groningen, Beatrix Children's Hospital
Groningen, Provincie Groningen, Netherlands, 9700 RB
3
University Medical Center Utrecht, Wilhelmina Children's Hospital
Utrecht, Utrecht, Netherlands, 3508 AB
4
VU University Medical Center Amsterdam
Amsterdam, Netherlands, 1007 MB