Corticosteroid Dosage for Crohn's Disease Flare

Clinical Trial ID: NCT02392286

Description

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.


Criteria

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

    2015-03-31

  • Last Updated

    2018-01-05

  • Sponsor

    Yale University

  • Condition Name

    Inflammatory Bowel Disease

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