Prevention of MTX induced psychological intolerance in children with Juvenile Idiopathic arthritis.

Phase III effectiveness 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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25952

Enrollment

130

Registered

2006-12-14

Start date

2007-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with JIA (all subtypes) aging 4 to 17 years

Interventions

Patients will be randomised for 1. Behavioral therapy plus continuation of oral MTX (intervention)

2. Switch to parenteral MTX (control) 3. Continuation of standard of care plus anti-emetic drugs (control).

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. MTX parenteral; 2. Other diagnosis; 3. Steroid usage (more than 0.2mg/kg/day); 4. Other MTX related side effects.

Design outcomes

Primary

Measure	Time frame
1. The number of patients continuing MTX; 2. Number of patients reporting gastrointestinal side effects; 3. JIA disease activity parameters. Measured: 0, 3, 6 and 12 months.	—

Secondary

Measure	Time frame
1. JIA disease activity parameters (PRINTO core set criteria);. 2. Metabolomics and folate/homocysteine/adenosine metabolites; 3. Inflammation parameters (ESR, CRP, cytokine profiles, Tregs, MMR antibodies); 4. MTX related cytopenias. Measured: 0, 3, 6 and 12 months.	—

Contacts

Public ContactN. Wulffraat

University Medical Center Utrecht (UMCU), Department of Pediatric immunology and rheumatology, KC 03.063 P.O. Box 85090

N.Wulffraat@umcutrecht.nl+31 (0)30 2504003

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)