Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

• 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
• 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

Vasculitis

Dermatomyositis

Intervention(s)

Drug: Prednisolone

Drug: Methylprednisolone

Secondary ID(s)

199/11924

NU-465

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ann & Robert H Lurie Children's Hospital of Chicago