Corticosteroid Dosage for Crohn's Disease Flare

Stopped early · Phase 4

Conditions studied: Crohn's Disease, Inflammatory Bowel Disease

In brief

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

Key facts

Study ID

NCT02392286

Run by

Yale University

People needed

15

Starts

2015-03-01

Expected to finish

2016-12-19

Last updated by the study team

2021-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Yale-New Haven Hospital — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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