juvenile idiopathic arthritis jeugdreuma treatment strategy behandelings strategie
Conditions
Interventions
After informed consent, patients will be randomised to one of 3 treatment strategies:
1. Initial sulfasalazine 50 mg/kg/dag, next methotrexate 10 mg/m2/week (followed by MTX dose increase 15 mg/m2/w
Sponsors
LUMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. All new patients with JIA with the oligo- and polyarticular subtype, treated in one of the Dutch pediatric rheumatology centers with a maximum of 18 months symptoms with active disease despite 4 months NSAIDs and/or intra-articular steroids.
Exclusion criteria
Exclusion criteria: 1. Systemic JIA 2. Pretreatment with methotrexate, prednisone and/or etanercept (for > 3 months) 3. Bone marrow hypoplasia 4. Sepsis or risk of sepsis 5. Current or recent infections (last three months), including chronic or localized: evidence of active CMV or EBV, infectious hepatitis, active pneumocystis carinii, drug resistant atypical mycobacterium or other bacterial infections. Documented HIV infection 6. Positive signs or symptoms, by physical examination or PPD and/or X-thorax, of latent or active tuberculosis in patients who cannot/will not be treated with the appropriate antibiotic treatment, as recommended by the local specialist 7. History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or splenomegaly 8. Other comorbidity that prevents treatment with oral corticosteroids and/or sulfasalazine and/or methotrexate and/or etanercept, or other comorbidity that, in the opinion of the pediatrician, prevents participation in the trial 9. Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study 10. Previous clinical trial involvement in last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to remission. 2. Time to flare. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PRINTO-score. 2. Quality of Life. 3. Safety. 4. Joint damage. 5. Costs of medication. Nature and extent of the burden and risks associated. | — |
Contacts
Public ContactR. Cate, ten
Leiden University Medical Center (LUMC) Pediatric rheumatologist Department of pediatrics P.O. Box 9600
Outcome results
None listed