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

PHASE3CompletedINTERVENTIONAL
Enrollment

139

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

May 12, 2011

Study Completion Date

November 29, 2015

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.

Trial Locations (1)

16147

Istituto Giannina Gaslini, Genoa

All Listed Sponsors
collaborator

Pediatric Rheumatology International Trials Organization

OTHER

lead

Istituto Giannina Gaslini

OTHER

NCT00323960 - Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis | Biotech Hunter | Biotech Hunter