FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND

Active, not recruiting

• Conditions: ew Onset juvenile dermatomyositis; MedDRA version: 6.1Level: PTClassification code 10012503

• Registration Number: EUCTR2005-003956-37-IT
• Lead Sponsor: ISTITUTO GIANNINA GASLINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-12
• Last Update Posted: 14 August 2012

Recruitment & Eligibility

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

Inclusion Criteria

-newly diagnosed and untreated children with probable or definit diagnosis of jdm according to the Bohan and Peter criteria -age at enrolment or 18 years -informed consent signed by the parents/patients
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

-neutrophil count 1500 cell/mm3 e/o platelets 50000/ mm3 -demonstration of cutaneous or gastrointestinal ulceration of JDM related polmonar disease or cardiomyopathy at the time of diagnosis

Study & Design

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