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Phase II Study of Methylprednisolone and Xylose Absorption in Children with Hypersensitivity Vasculitis Associated with Connective Tissue Disease



Phase II Study of Methylprednisolone and Xylose Absorption in Children with Hypersensitivity Vasculitis Associated with Connective Tissue Disease

For Condition: Vasculitis, Hypersensitivity,Vasculitis,Connective Tissue Diseases,Dermatomyositis
Status: Recruiting
Sponsor(s): National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) , Children's Memorial Hospital, Chicago
Synopsis: OBJECTIVES: I. Assess xylose absorption and blood levels of neopterin and von Willebrand factor antigen in children with active hypersensitivity vasculitis associated with connective tissue disease. II. Correlate the bioavailability and kinetic rate constant of absorption of oral methylprednisolone with that of xylose. III. Compare the bioavailability and kinetic rate constant of absorption of oral methylprednisolone during active and quiescent disease in the same child.
Details: PROTOCOL OUTLINE: Following a 12-hour fast, patients receive oral xylose and 2 hours later, oral methylprednisolone. The following day, patients receive intravenous methylprednisolone. Pharmacokinetic studies are performed each day. Patients are re-treated when disease becomes inactive (6-12 months later).
Eligibility:
Study Type:
  Interventional, Treatment, Bio-availability Study
Minimum Age/Maximum Age: 4 Years/18 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Juvenile dermatomyositis with evidence of active vasculitis - Hemoglobin at least 9 g/dL Exclusion Criteria: - Severe renal involvement - Critically ill or unstable - Diseases other than dermatomyositis with vasculitis
Total Enrollment: 24

Location and Contact Information:

Overall Study Official:
LaurenPachman,  Study Chair,  Children's Memorial Hospital, Chicago

Children's Memorial Hospital, Chicago *Recruiting*
Chicago,  Illinois,  60614
United States
Recruiting Lauren  Pachman 312-880-4360


Additional Information:
Study ID Numbers:
  199/11924;  NU-465
Study Start Date: September 1997
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004357

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4. Comparison of Treatments to Maintain Disease Remission in Patients with Wegener's Granulomatosis and Related Vasculitis Syndromes

5. Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients with Wegener's Granulomatosis

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