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Sponsors and Collaborators: |
Northwestern University Children's Memorial Hospital |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00004357 |
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 |
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Vasculitis, Hypersensitivity Connective Tissue Diseases Dermatomyositis Vasculitis |
Drug: Methylprednisolone Drug: Prednisolone |
Phase II |
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 |
Estimated Enrollment: | 24 |
Study Start Date: | September 1997 |
Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 4 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lauren M. Pachman, MD | 773-880-4360 | pachman@northwestern.edu |
Contact: Kelly Rouster-Stevens, MD, PharmD | 773-880-4360 |
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 |
Principal Investigator: | Lauren M. Pachman, MD | Feinberg School of Medicine, Northwestern University |
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 |
Cardiovascular Disease Respiratory Disease Rare Diseases Vasculitis |
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 |
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 |