Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

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.

ClinicalTrials.gov Identifier: NCT00004357

Recruitment Status : Completed

First Posted : October 19, 1999

Last Update Posted : July 22, 2011

Sponsor:

Collaborator:

Ann & Robert H Lurie Children's Hospital of Chicago

Information provided by:

Northwestern University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Vasculitis, Hypersensitivity Connective Tissue Diseases Dermatomyositis Vasculitis	Drug: Methylprednisolone Drug: Prednisolone	Phase 2

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 Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
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
Study Start Date :	September 1997
Actual Primary Completion Date :	December 2005
Actual Study Completion Date :	February 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

Genetic and Rare Diseases Information Center resources: Dermatomyositis Juvenile Dermatomyositis Polymyositis Idiopathic Inflammatory Myopathy

U.S. FDA Resources

Arms and Interventions

Intervention Details:

Drug: Methylprednisolone
IV
Drug: Prednisolone
Oral

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information

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

Layout table for location information

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

Layout table for investigator information

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

More Information

Layout table for additonal information

Responsible Party:	Lauren Pachman MD, Children's Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00004357
Other Study ID Numbers:	199/11924 NU-465
First Posted:	October 19, 1999 Key Record Dates
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:

Layout table for MeSH terms

Dermatomyositis Vasculitis Vasculitis, Leukocytoclastic, Cutaneous Connective Tissue Diseases Hypersensitivity Immune System Diseases Vascular Diseases Cardiovascular Diseases Polymyositis Myositis Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Skin Diseases	Immune Complex Diseases Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids

To Top