EUCTR2007-001861-14-NL
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Medical Center Utrecht
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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