Corticosteroid Dosage for Crohn's Disease Flare

A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares

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