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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR844 |
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Date of registration:
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14/12/2006 |
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Primary sponsor: |
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Public title:
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Prevention of MTX induced psychological intolerance in children with Juvenile Idiopathic arthritis.
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Scientific title:
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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. - Gastrointestinal side effects of MTX in patients with JIA |
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Date of first enrolment:
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1/3/2007 |
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Target sample size:
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130 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=844 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Not applicable; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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N.
Wulffraat |
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Address:
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University Medical Center Utrecht (UMCU),
Department of Pediatric immunology and rheumatology,
KC 03.063
P.O. Box 85090
3508 AB
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2504003 |
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Email:
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N.Wulffraat@umcutrecht.nl |
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Affiliation:
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Name:
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N.
Wulffraat |
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Address:
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University Medical Center Utrecht (UMCU),
Department of Pediatric immunology and rheumatology,
KC 03.063
P.O. Box 85090
3508 AB
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2504003 |
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Email:
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N.Wulffraat@umcutrecht.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 1. MTX parenteral;
2. Other diagnosis;
3. Steroid usage (more than 0.2mg/kg/day);
4. Other MTX related side effects.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Juvenile idiopathic arthritis (JIA)
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Intervention(s)
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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).
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN13524271
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N/A
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Source(s) of Monetary Support
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Medac, Pharmachmie
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