Phase III Clinical Trials in New Onset Juvenile Dermatomyositis: Steroids Treatment versus Steroids plus Cyclosporine Treatment versus Steroids plus Methotrexate Treatment.
Recruiting
- Conditions
- ewly onset juvenile dermatomyositis patients.
- Registration Number
- NL-OMON23726
- Lead Sponsor
- no commercial sponsoring. International organisation is PRINTO (pediatric rheumatology International trials organisation
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. Newly onset juvenile dermatomyositis;
2. Patients aged <18 years;
Exclusion Criteria
1. Neutropenia;
2. Failure to comply;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to clinical remission.
- Secondary Outcome Measures
Name Time Method 1. Change over time in the clinical core set parameters (PRINTO core set for JDM);<br /><br>2. Time to muscle enzyme normalisation;<br /><br>3. Frequency of drop out due to ineffective treatment.