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Corticosteroid Dosage for Crohn’s Disease Flare

September 12, 2019


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



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



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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