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 mehotrexate

• Conditions: Juvenile Dermatomyositis at onset

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-01
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

10
Newly diagnosed and untreated children 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 the PRINTO coordinating centre.
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