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Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

This study has been completed.
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004357
First received: October 18, 1999
Last updated: July 20, 2011
Last verified: July 2011
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Lauren Pachman MD, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00004357     History of Changes
Other Study ID Numbers: 199/11924, NU-465
Study First Received: October 18, 1999
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Connective Tissue Diseases
Dermatomyositis
Hypersensitivity
Vasculitis
Vasculitis, Leukocytoclastic, Cutaneous
Cardiovascular Diseases
Immune Complex Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Myositis
Nervous System Diseases
Neuromuscular Diseases
Polymyositis
Skin Diseases
Vascular Diseases
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on November 27, 2014