Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study
- Conditions
- Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects
- Registration Number
- EUCTR2006-006812-31-DE
- Lead Sponsor
- niversity of Munster
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1. diagnosis: all subtypes JIA according to ILAR classification (15).
2. MTX oral (dosing 10-20mg/m2/week)
3. other medication: NSAID, biologicals (etanercept, infliximab, anakinra) allowed
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1. MTX parenteral
2. Other diagnosis
3. Steroid usage (more than 0.2mg/kg/day)
4. Other MTX related side effects:
4a. Abnormal Liver function tests (definitie (1) waarsch verdubbeling uitgangswaarde
4b. Abnormal renal function tests (serum creatinin increasing to twice baseline values)
4c. Cytopenias (see above(1))
5. History of non-compliance to earlier treatments not related to MTX
6. Patients currently included in other studies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method