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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00004357
Date of registration: 18/10/1999
Prospective Registration: No
Primary sponsor: Northwestern University
Public title: Absorption of Corticosteroids in Children With Juvenile Dermatomyositis
Scientific title: Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis
Date of first enrolment: September 1997
Target sample size: 6
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00004357
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Lauren M. Pachman, MD
Address: 
Telephone:
Email:
Affiliation:  Feinberg School of Medicine, Northwestern University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Juvenile dermatomyositis with evidence of active vasculitis

- Elevated von Willebrand factor antigen prior to study entry

- Elevated neopterin level prior to study entry

Exclusion Criteria:

- Severe renal involvement

- Critically ill or clinically unstable

- Diseases other than dermatomyositis with vasculitis



Age minimum: 4 Years
Age maximum: 21 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Vasculitis, Hypersensitivity
Connective Tissue Diseases
Dermatomyositis
Vasculitis
Intervention(s)
Drug: Prednisolone
Drug: Methylprednisolone
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
NU-465
199/11924
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ann & Robert H Lurie Children's Hospital of Chicago
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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