Prevention of methotrexate induced psychological intolerance in children with juvenile idiopathic arthritis

Completed

• Conditions: Juvenile Idiopathic arthritis (JIA); Musculoskeletal Diseases; Arthropathies

• Registration Number: ISRCTN13524271
• Lead Sponsor: niversity Medical Center Utrecht (UMCU) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

1. Diagnosis: all subtypes JIA according to International League of Associations for Rheumatology (ILAR) classification
2. Ages four to 17 years
3. MTX oral (dosing 10 to 20 mg/m^2/week)
4. Other medication: Non-Steroidal Anti-Inflammatory Drug (NSAID), biologicals (etanercept, infliximab, anakinra) allowed

Exclusion Criteria

1. MTX parenteral
2. Other diagnosis
3. Steroid usage (more than 0.2 mg/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><br>Measured: zero, three, six and 12 months.

Secondary Outcome Measures

Name	Time	Method
1. JIA disease activity parameters (Pediatric Rheumatology InterNational Trials Organisation [PRINTO] core set criteria)<br>2. Metabolomics and folate/homocysteine/adenosine metabolites<br>3. Inflammation parameters (Erythrocyte Sedimentation Rate [ESR], C-Reactive Protein [CRP], cytokine profiles, T regulatory [T-regs] cells, Measles, Mumps, Rubella [MMR] antibodies)<br>4. MTX related cytopenias<br><br>Measured: zero, three, six and 12 months.