Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

Dermatomyositis Clinical Trial

Official title:

Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004357
• Other study ID #: 199/11924
• Secondary ID: NU-465
• Status: Completed
• Phase: Phase 2
• First received: October 18, 1999
• Last updated: July 20, 2011
• Start date: September 1997
• Est. completion date: February 2008

Study information

• Verified date: July 2011
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Juvenile dermatomyositis (JDM) is a connective tissue disease that causes skin rash and weak muscles in children. The purpose of this study is to measure the absorption of oral prednisolone and intravenous (IV) methylprednisolone and to determine levels of disease activity indicators in the blood. These levels will be compared to see if there are patterns specific to active and less active JDM.

Description:

JDM is a connective tissue disease that is characterized by inflammation of the muscles and the skin. Corticosteroids, such as prednisolone and methylprednisolone, can be administered to help control symptoms of the disease, but absorption patterns of these medications in oral and IV forms are unknown. This study will assess absorption of oral prednisolone and IV methylprednisolone, measure levels of two disease activity indicators (von Willebrand factor and neopterin), and correlate these values in children with JDM.

Patients will participate in this study twice within a period of up to a year, once when the patient's disease is active, and again 6 to 12 months later when the disease is less active. Each of the two study periods will last two nights and two days. Patients will be admitted to the hospital the first night, and a small IV port will be inserted in the patient's arm the first morning to allow for multiple blood draws without additional needle sticks. Patients will receive oral prednisolone the first morning and IV methylprednisolone the second morning. Baseline blood draws will be performed prior to administration of drug, with 13 additional draws over a 6 hour period following drug administration. Following the final blood draw on the second day, the IV port will be removed from the patient's arm and the patient will be discharged from the hospital.

Blood drawn from patients will be assessed for absorption of the drugs and levels of von Willebrand factor and neopterin. Patients will undergo the same sequence of events sometime between 6 to 12 months after the first hospitalization, after their vasculitis is judged to be less active.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2008
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 21 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Dermatomyositis
• Hypersensitivity
• Vasculitis
• Vasculitis, Hypersensitivity

Intervention

Drug:
• Methylprednisolone
IV
• Prednisolone
Oral

Locations

Country	Name	City	State
United States	Children's Memorial Hospital, Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States,