Absorption of Corticosteroids in Children With Juvenile Dermatomyositis
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| ClinicalTrials.gov Identifier: NCT00004357 |
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Recruitment Status :
Completed
First Posted : October 19, 1999
Last Update Posted : July 22, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vasculitis, Hypersensitivity Connective Tissue Diseases Dermatomyositis Vasculitis | Drug: Methylprednisolone Drug: Prednisolone | Phase 2 |
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 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 |
- Drug: Methylprednisolone
IV
- Drug: Prednisolone
Oral
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| Ages Eligible for Study: | 4 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| United States, Illinois | |
| Children's Memorial Hospital, Chicago | |
| Chicago, Illinois, United States, 60614 | |
| Principal Investigator: | Lauren M. Pachman, MD | Feinberg School of Medicine, Northwestern University |
| 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 Key Record Dates |
| Last Update Posted: | July 22, 2011 |
| Last Verified: | July 2011 |
Keywords provided by Northwestern University:
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Cardiovascular Disease Respiratory Disease Rare Diseases Vasculitis |
Additional relevant MeSH terms:
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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 |