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

NCT00323960 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2023-03-28

Study results available
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Summary

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

Conditions

  • Juvenile Dermatomyositis

Interventions

DRUG

3 MPDN pulse + PDN

3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years.

DRUG

3 MPDN pulse + PDN + CSA

3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Cyclosporine 5 mg/Kg/day in 2 oral doses

DRUG

3 MPDN pulse + PDN + MTX

3 methylprednisolone pulses followed (30 mg/kg/pulse max 1 gram) followed by prednisone 2 mg/Kg/day to be tapered to 0.2 mg/kg/day in 6 months and then discontinued in 2 years; Methotrexate 15-20 mg/m2 once per week. Patients treated with MTX will receive concomitant folic or folinic acid according to the attending physician decision.

Sponsors & Collaborators

  • Pediatric Rheumatology International Trials Organization

    collaborator OTHER

  • Istituto Giannina Gaslini

    lead OTHER

Principal Investigators

  • Nicolino Ruperto, MD, MPH · Istituto Giannina Gaslini _ PRINTO Senior Scientist

  • Alberto Martini, MD, Prof. · Istituto Giannina Gaslini_PRINTO Chairman

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2011-05-12
Completion
2015-11-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323960 on ClinicalTrials.gov