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
Completed
- Conditions
- Juvenile Idiopathic Arthritis10023213
- Registration Number
- NL-OMON38373
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
gastrointestinal side effects of MTX in patients with JIA
Pediatric ALL with MTX maintenance treatment
Adults with RA or psoriatic artritis with MTX maintenance treatment
Exclusion Criteria
parenteral MTX usage ( page17 protocol)
other causes of MTX toxicity
other diagnosis
failure to comply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>number of patients reporting gastrointestinal side effects</p><br>
- Secondary Outcome Measures
Name Time Method <p>number of patients stopping MTX<br /><br>JIA disease activity parameters (PRINTO core set criteria, based on which the<br /><br>Juvenile Arthritis Disease Activity Score (JADAS) will be calculated).<br /><br>Metabolomics and folate/homocysteine/adenosine metabolites and Inflammation<br /><br>parameters (ESR, CRP, cytokine profiles, Tregs, MMR antibodies), and MTX<br /><br>related cytopenias</p><br>