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Clinical Trials/EUCTR2006-006812-31-DE
EUCTR2006-006812-31-DE
Active, not recruiting
Phase 1

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

niversity of Munster0 sites120 target enrollmentJune 25, 2008
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ConditionsPatients with Juvenile Idiopathic Arthritis and Methotrexate related side effects
Drugsmetoject

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects
Sponsor
niversity of Munster
Enrollment
120
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 25, 2008
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Munster

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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