Corticosteroid Dosage for Crohn's Disease Flare

Yale University

Status and phase

Terminated

Phase 4

Conditions

Inflammatory Bowel Disease

Crohn's Disease

Treatments

Drug: Corticosteroid

Study type

Interventional

Funder types

Other

Identifiers

NCT02392286

1501015143

Details and patient eligibility

About

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

Full description

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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