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Clinical trialNCT00323960CompletedPhase 3Interventional

Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis

SponsorIstituto Giannina GasliniEnrollment139Juvenile Dermatomyositis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a 5-year project, involving 185 partners from 46 countries ((110 in 21 European Union (EU) States and 75 in 25 extra-EU States)), with a randomised clinical trials (RCT) in juvenile dermatomyositis (JDM): 5-year phase III single-blind, RCT in children with newly diagnosed JDM: prednisone (PDN) versus PDN plus methotrexate (MTX) versus PDN plus Cyclosporine A. The trial is aimed to find out the treatment regimen associated with the lowest occurrence of flare and the lowest drug related toxicity
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Alberto Martini, MD, Prof.

    Istituto Giannina Gaslini_PRINTO Chairman

    Study Chair
    clinicaltrials.gov ↗
  • Nicolino Ruperto, MD, MPH

    Istituto Giannina Gaslini _ PRINTO Senior Scientist

    Principal Investigator
    clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Italy
  • Istituto Giannina Gaslini

    Genoa, Italy

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

3 MPDN pulse + PDN3 MPDN pulse + PDN + CSA3 MPDN pulse + PDN + MTX
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 May 2006
Primary completion
12 May 2011
Completion
29 Nov 2015
Last update posted
28 Mar 2023
Registered enrollment
139
Registry id
NCT00323960
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.