Juvenile Dermatomyositis at onset
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration number: 5-
Pharmaceutical Form: Powder and solvent for solution for i
Sponsors
Istituto Giannina Gaslini
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Italy, Netherlands, Sweden, United Kingdom
Outcome results
None listed