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Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004357
First Posted: October 19, 1999
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by:
Northwestern University
  Purpose
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.

Condition Intervention Phase
Vasculitis, Hypersensitivity Connective Tissue Diseases Dermatomyositis Vasculitis Drug: Methylprednisolone Drug: Prednisolone Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Enrollment: 6
Study Start Date: September 1997
Study Completion Date: February 2008
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Methylprednisolone
    IV
    Drug: Prednisolone
    Oral
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004357


Locations
United States, Illinois
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Northwestern University
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Lauren M. Pachman, MD Feinberg School of Medicine, Northwestern University
  More Information

Responsible Party: Lauren Pachman MD, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00004357     History of Changes
Other Study ID Numbers: 199/11924
NU-465
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Northwestern University:
Cardiovascular Disease
Respiratory Disease
Rare Diseases
Vasculitis

Additional relevant MeSH terms:
Dermatomyositis
Hypersensitivity
Vasculitis
Connective Tissue Diseases
Vasculitis, Leukocytoclastic, Cutaneous
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Skin Diseases
Immune Complex Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents