Corticosteroid Dosage for Crohn's Disease Flare

Clinical Trial ID: NCT02392286


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

- Determine if weight-based corticosteroid (1mg/kg daily) induces remission at a greater rate than fixed corticosteroid dosage. - Determine if weight-based corticosteroid is associated with greater rate of adverse events than fixed corticosteroid dosage.


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

  • Start Date


  • Last Updated


  • Sponsor

    Yale University

  • Condition Name

    Inflammatory Bowel Disease

Learn about this trial.

Check the eligibility requirements, study details, and more.

Related Trials

Different trials target different symptoms, condition types, and patients. Learn more about other emergeing treatments being investigated now.