Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

• ClinicalTrials.gov Identifier: NCT00004357
• Recruitment Status: Completed
• First Posted: October 19, 1999
• Last Update Posted: July 22, 2011
• Sponsor: Northwestern University
• 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

• 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

Arms and Interventions

Intervention Details:

• Drug: Methylprednisolone
  IV
• Drug: Prednisolone
  Oral

Outcome Measures

Eligibility Criteria

• 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

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 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; 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; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents