Corticosteroid Dosage for Crohn's Disease Flare

Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Age Range:18 - Any
Start Date:March 2015
End Date:December 2019
Contact:Loren Laine, MD

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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

- 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
We found this trial at
20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
New Haven, CT
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