Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

July 20, 2011 updated by: Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital, Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Lauren M. Pachman, MD, Northwestern University Feinberg School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1997

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 18, 1999

First Submitted That Met QC Criteria

October 18, 1999

First Posted (Estimate)

October 19, 1999

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/11924
  • NU-465

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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