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Phase III Clinical Trials in New Onset Juvenile Dermatomyositis: Steroids Treatment versus Steroids plus Cyclosporine Treatment versus Steroids plus Methotrexate Treatment.


- candidate number2065
- NTR NumberNTR667
- ISRCTNIncomplete info for ISRCTN
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2006
- Secondary IDsN/A 
- Public TitlePhase III Clinical Trials in New Onset Juvenile Dermatomyositis: Steroids Treatment versus Steroids plus Cyclosporine Treatment versus Steroids plus Methotrexate Treatment.
- Scientific TitleFive year single blind, Phase III effectiveness randomised actively controlled Clinical Trial in New Onset Juvenile Dermatomyositis: Steroids Treatment versus Steroids plus Cyclosporine Treatment versus Steroids plus Methotrexate Treatment.
- ACRONYMClinical Trial in New Onset Juvenile Dermatomyositis
- hypothesisCombination therapy of steroids plus MTX induces remission faster and will therefor reduce steroid toxicity and disease damage.
- Healt Condition(s) or Problem(s) studiedDermatomyositis
- Inclusion criteria1. Newly onset juvenile dermatomyositis;
2. Patients aged <18 years;
3. Negative pregnancy test;
4. Obtained informed consent;
5. Ability to comply.
- Exclusion criteria1. Neutropenia;
2. Failure to comply;
3. Ulcerations, cardio-pulmonary disease related to juv dermatomyositis.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2006
- planned closingdate1-jun-2013
- Target number of participants160
- InterventionsRandomisation into 3 groups:
1. Standard therapy steroids only;
2. Steroids plus methotrexate;
3. Steroids plus ciclosporin.
- Primary outcomeTime to clinical remission.
- Secondary outcome1. Change over time in the clinical core set parameters (PRINTO core set for JDM);
2. Time to muscle enzyme normalisation;
3. Frequency of drop out due to ineffective treatment.
- TimepointsN/A
- Trial web sitehttp://www.printo.it
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. J.T. Dissel, van
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.T. Dissel, van
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD20-apr-2006 - 23-apr-2008


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