Corticosteroid Dosage for Crohn's Disease Flare

• Status: Terminated
• Trial end date: 2016-12-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

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