Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate

Phase 1

• Conditions: Juvenile Dermatomyositis at onset

• Registration Number: EUCTR2005-003956-37-DK
• Lead Sponsor: Istituto Giannina Gaslini

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-15
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Newly diagnosed and untreated children (only treatment with 1 NSAID is allowed
and/or prednisone >1 mg/kg/day for no more than 1 month from diagnosis) with
probable or definite diagnosis of JDM according to the Bohan and Peter criteria (12;13).
If a muscle biopsy will be performed (optional) it will be read by the pathologists of the
participating centres (light and immunofluorescence). Slides of paraffin-embedded
sections from all patients will be re-viewed by a blinded myopathologist at PRINTO.
2) Age at enrolment = 18 years.
3) Female of child-bearing potential must have a negative pregnancy test at the beginning
of the trial, and then every 3 months. If sexually active, they must agree to use adequate
contraception, throughout study participation, and must have no intention of conceiving
during the course of the study. Post-pubertal males must have no plans to father a child
during the study and agree to use adequate birth control methods if sexually active.
4) Ability to comply with the entire study procedures, ability to communicate
meaningfully with the investigational staff, competence to give written informed
consent; to be applied to the parents and/or patients, as appropriate
5) Duly executed, written, informed consent obtained from the parents/patient.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Neutrophil count <1,500/mm3 and/or platelet count <50,000/mm3
2) Demonstration of cutaneous or gastrointestinal ulceration of JDM related
pulmonary disease or cardiomyopathy at the time of diagnosis.
3) History of poor compliance.
4) Evidence of current use of alcohol or illicit drugs abuse.
5) Live vaccines not allowed during the entire duration of the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effectiveness (efficacy, safety, tolerability and compliance to treatment) of the 3 treatment approaches for the treatment of children with JDM;Secondary Objective: The overall hypothesis to be tested in this trial is that the early introduction of combination therapy of corticosteroids and either MTX or CsA will prove more effective and safe than corticosteroids alone in the treatment of JDM;Primary end point(s): to assess the effectiveness (efficacy, safety, tolerability and compliance to treatment) of the 3 treatment approaches for the treatment of children with JDM