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Absorption of Corticosteroids in Children With Juvenile Dermatomyositis

This study is currently recruiting participants.
Verified by Northwestern University, May 2004

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   

ChemIDplus related topics:   Prednisolone    6-Methylprednisolone    Depo-medrol    Medrol veriderm    Methylprednisolone    Methylprednisolone hemisuccinate    Methylprednisolone Sodium Succinate    Prednisolone acetate    Prednisolone sodium phosphate    Prednisolone Sodium Succinate    Corticosteroids   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

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


Study ID Numbers:   199/11924, NU-465
First Received:   October 18, 1999
Last Updated:   May 9, 2006
ClinicalTrials.gov Identifier:   NCT00004357
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:
Juvenile dermatomyositis
Vasculitis
Skin Diseases
Methylprednisolone
Respiration Disorders
Vascular Diseases
Rare Diseases
Methylprednisolone acetate
Vasculitis, Hypersensitivity
Prednisolone acetate
Myositis
Dermatomyositis
Hypersensitivity
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Prednisolone
Connective Tissue Diseases
Polymyositis
Idiopathic myopathy
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immune Complex Diseases
Immune System Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Protective Agents
Neuroprotective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




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