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Corticosteroid Dosage for Crohn’s Disease Flare

September 12, 2019

Overview

This study compares fixed dosing and weight-based dosing of corticosteroids in patients with Crohn’s disease flares. The comparison attempts to uncover if weight-based corticosteroid leads to remission at a greater rate than a fixed corticosteroid dosage. Additionally, the study determines if weight-based corticosteroid has less risks than a fixed corticosteroid dosage.

 

Study Information

For weight-based corticosteroid, subjects will receive prednisone at 1 milligram per kilometer (weight of subject) orally; if intravenous corticosteroid is required they will receive methylprednisolone for the first 3-4 days of therapy. For fixed dose corticosteroid, subjects will receive medicine in the same manner, but at a fixed dose of 40 milligrams. Responses or remission will be evaluated at the end of 2 weeks, 4 weeks, and 12 weeks. Corticosteroid-associated side effects will be evaluated at the end of 12 weeks.

 

Inclusion Criteria

  • All sexes, ages 18 or older
  • Diagnosed with Crohn’s disease
  • Diagnosis of Crohn’s flare
  • Permission to allow gastroenterologist to start corticosteroid therapy

 

Exclusion Criteria

  • Patients where corticosteroid therapy is contraindicated by: 
    • active cancer with chemotherapy or radiation 
    • severe liver disease
    • end-stage renal disease on dialysis
    • AIDS or AIDS-defining illness
    • myocardial infarction within the past year
    • NYHA Class 4 heart failure
  • Patients on systemic corticosteroid therapy currently or within the past 8 weeks
  • Patients not on stable doses of immunomodulators or biologics for at least 8 weeks
  • Infectious colitis (e.g., C. difficile, CMV, HSV)
  • Systemic infections (bacteremia, fungal infections)
  • Fulminant Crohn’s disease
  • Patients who require imminent surgery
  • Abscess
  • Pregnancy
  • Weight less than 35 kg

 

Locations

You may participate in this study at Yale-New Haven Hospital in New Haven, Connecticut, United States, 06510. If you have any questions or concerns, feel free to contact Sunhee Park, MD at sunhee.park@yale.edu

 

Sponsors/Collaborators

This clinical trial is sponsored by Yale University with Loren Laine, MD of Yale University, Section of Digestive Diseases as the Principal Investigator.

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