Corticosteroid Dosage for Crohn's Disease Flare


Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.

Study Start Date

March 2015

Estimated Completion Date

December 2016


  • Drug: Corticosteroid


  • Gastroenterology: Inflammatory Bowel Dz
  • Physician Assistant: Gastroenterology

MeSH Terms

  • Crohn Disease

Study ID

Yale University -- 1501015143



Trial ID


Study Type


Trial Phase

Phase 4

Enrollment Quota



Yale University

Inclusion Criteria

  • Age ? 18
  • Established diagnosis of Crohn's disease
  • Diagnosis of Crohn's flare
  • Decision by treating gastroenterologist to start corticosteroid therapy

Exclusion Criteria

  • Patients in whom corticosteroid therapy is contraindicated: immunocompromised (active cancer on chemotherapy or radiation treatment), severe liver disease (decompensated cirrhosis, active alcoholic hepatitis), 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 <35 kg




18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
YaleNew Haven Hospital - New Haven, Connecticut 18.2 miles Loren Laine MD None provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.