Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine - safety and efficacy of MMR vaccination in JIA patients

• Conditions: Juvenile Idiopathic Arthritis; MedDRA version: 14.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2007-001861-14-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-29
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- all subtypes of Juvenile Idiopathic Arthritis (JIA) patients according to ILAR criteria
- ages 4 - 9 (this is 2 years after initial MMR and before the scheduled booster, usually given at age 9)
- five healthy controls (18-65 years)

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Use of Infliximab (Remicade, anti-TNF alpha therapy).
- Primary immunodeficiency
- Fever less than 48 hour prior to vaccination (here the moment of vaccination will be postponed for 1 month)
- Evidence of viral or bacterial infection less than 48hours prior to vaccination (here the moment of vaccination will be postponed for 1 month)
- Methylprednisolon pulse therapy less than 1 month prior to vaccination (in these cases, the moment of vaccination will be postponed for 1 month)

for healthy controls:
-serious adverse events to previous MMR vaccination
-Use of immunosuppressive drugs
-Primary immunodeficiency
-Fever less than 48 hour prior to vaccination (vaccination will be postponed)
-Evidence of viral or bacterial infection less than 48hours prior to vaccination (vaccination will be postponed)
-Methylprednisolon pulse therapy less than 1 month prior to vaccination (vaccination will be postponed)
-Pregnancy
-Lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified