Overview

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