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Absorption of Corticosteroids in Children With Juvenile Dermatomyositis
This study is currently recruiting participants.
Verified by Northwestern University, May 2004
First Received: October 18, 1999   Last Updated: February 13, 2009   History of Changes
Sponsors and Collaborators: Northwestern University
Children's Memorial Hospital
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00004357
  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 II

MedlinePlus related topics: Allergy Connective Tissue Disorders Vasculitis
Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title: Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis

Further study details as provided by Northwestern University:

Estimated Enrollment: 24
Study Start Date: September 1997
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004357

Contacts
Contact: Lauren M. Pachman, MD 773-880-4360 pachman@northwestern.edu
Contact: Kelly Rouster-Stevens, MD, PharmD 773-880-4360

Locations
United States, Illinois
Children's Memorial Hospital, Chicago Recruiting
Chicago, Illinois, United States, 60614
Contact: Lauren M. Pachman     773-880-4360        
Principal Investigator: Lauren M. Pachman, MD            
Principal Investigator: Kelly Rouster-Stevens, MD, PharmD            
Sponsors and Collaborators
Northwestern University
Children's Memorial Hospital
Investigators
Principal Investigator: Lauren M. Pachman, MD Feinberg School of Medicine, Northwestern University
  More Information

No publications provided

Responsible Party: Children's Memorial Hospital ( Lauren Pachman MD )
Study ID Numbers: 199/11924, NU-465
Study First Received: October 18, 1999
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00004357     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Vasculitis, Hypersensitivity
Prednisolone acetate
Neuroprotective Agents
Hormones
Myositis
Hypersensitivity
Dermatomyositis
Neuromuscular Diseases
Musculoskeletal Diseases
Polymyositis
Connective Tissue Diseases
Methylprednisolone Hemisuccinate
Idiopathic Myopathy
Vasculitis
Antineoplastic Agents, Hormonal
Skin Diseases
Respiration Disorders
Rare Diseases
Vascular Diseases
Methylprednisolone acetate
Juvenile Dermatomyositis
Glucocorticoids
Muscular Diseases
Prednisolone
Peripheral Nervous System Agents

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immune Complex Diseases
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Vasculitis, Hypersensitivity
Prednisolone acetate
Neuroprotective Agents
Hormones
Myositis
Hypersensitivity
Dermatomyositis
Neuromuscular Diseases
Musculoskeletal Diseases
Therapeutic Uses
Polymyositis
Connective Tissue Diseases
Cardiovascular Diseases
Methylprednisolone Hemisuccinate
Vasculitis
Antineoplastic Agents, Hormonal
Immune System Diseases
Skin Diseases
Nervous System Diseases
Gastrointestinal Agents
Vascular Diseases
Methylprednisolone acetate
Protective Agents

ClinicalTrials.gov processed this record on May 07, 2009