Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 280
Study Overview
Brief Summary
(1) Wraith DC, Goldman M, Lambert PH. Vaccination and autoimmune disease: what is the evidence? Lancet 2003; 362(9396):1659-1666. (2) Verhasselt V, Goldman M. From autoimmune responses to autoimmune disease: what is needed? J Autoimmun 2001; 16(3):327-330. (3) Eden van W. Immunoregulation of autoimmune diseases. Hum Immunol 2006; 67(6):446-453. (4) Bach JF. Protective role of infections and vaccinations on autoimmune (5) Eden van W, Zee van der R, Koski CL et al. Balancing the immune system: Th1 and Th2. Ann Rheum Dis 2002; 61 Suppl 2:ii25-ii28. (6) Update: vaccine side effects, adverse reactions, contraindications, and precautions. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 1996; 45(RR-12):1-35. (7) Zonneveld-Huijssoon E, Ronaghy A, Van Rossum MA et al. Safety and efficacy of meningococcal c vaccination in juvenile idiopathic arthritis. Arthritis Rheum 2007; 56(2):639-646. (8) Heijstek MW, Pileggi C, Zonneveld-Huijssoon E et al. Safety of measles, mumps and rubella vaccination in Juvenile Idiopathic Arthritis. Ann Rheum Dis 2007. (9) Giannini EH, Ruperto N, Ravelli A, Lovell DJ, Felson DT, Martini A. Preliminary definition of improvement in juvenile arthritis. Arthritis Rheum 1997; 40(7):1202-1209. (10) Andrews N, Pebody RG, Berbers G et al. The European Sero-Epidemiology Network: standardizing the enzyme immunoassay results for measles, mumps and rubella. Epidemiol Infect 2000; 125(1):127-141.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. All subtypes of JIA according to ILAR criteria;
- •2. Ages 4 to 8
Exclusion Criteria
- •1. Use of Infliximab (Remicade, anti-TNF alpha therapy).
- •2. Use of Anakinra (Kineret, human interleukine-1-receptorantagonist)
- •3. Participation in another (drug) trial
- •4. Primary immunodeficiency
- •5. Fever less than 48 hour prior to vaccination (here the moment of vaccination will be postponed for 1 month)
- •6. Evidence of viral or bacterial infection less than 48hours prior to vaccination (here the moment of vaccination will be postponed for 1 month)
- •7. Methylprednisolon pulse therapy less than 1 month prior to vaccination (in these cases, the moment of vaccination will be postponed for 1 month)