Prevention of MTX induced psychological intolerance in children with Juvenile Idiopathic arthritis.
- Conditions
- Patients with JIA (all subtypes) aging 4 to 17 years
- Registration Number
- NL-OMON25952
- Lead Sponsor
- none (investigator driven)
- Brief Summary
pilot study submitted to Clin Exp Rheumatology
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
1. Diagnosis: all subtypes JIA according to ILAR classification;
2. Ages 4 to 17 years;
3. MTX oral (dosing 10-20mg/m2/week);
4. Other medication: NSAID, biologicals (etanercept, infliximab, anakinra) allowed.
Exclusion Criteria
1. MTX parenteral;
2. Other diagnosis;
3. Steroid usage (more than 0.2mg/kg/day);
4. Other MTX related side effects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The number of patients continuing MTX;<br>2. Number of patients reporting gastrointestinal side effects;<br>3. JIA disease activity parameters.<br>Measured: 0, 3, 6 and 12 months.
- Secondary Outcome Measures
Name Time Method 1. JIA disease activity parameters (PRINTO core set criteria);. <br>2. Metabolomics and folate/homocysteine/adenosine metabolites;<br>3. Inflammation parameters (ESR, CRP, cytokine profiles, Tregs, MMR antibodies);<br>4. MTX related cytopenias.<br>Measured: 0, 3, 6 and 12 months.