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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38373

Enrollment

620

Registered

2007-05-02

Start date

2007-08-09

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

Juvenile Idiopathic Arthritis

Interventions

Patients will be randomised for a) behavioral therapy plus continuation of oral MTX

b) switch to parenteral MTX

c) continuation of standard of care plus anti-emetic drugs. No randomisation for control groups

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: parenteral MTX usage ( page17 protocol) other causes of MTX toxicity other diagnosis failure to comply

Design outcomes

Primary

Measure	Time frame
number of patients reporting gastrointestinal side effects	—

Secondary

Measure	Time frame
number of patients stopping MTX JIA disease activity parameters (PRINTO core set criteria, based on which the Juvenile Arthritis Disease Activity Score (JADAS) will be calculated). Metabolomics and folate/homocysteine/adenosine metabolites and Inflammation parameters (ESR, CRP, cytokine profiles, Tregs, MMR antibodies), and MTX related cytopenias	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)