Corticosteroid Dosage for Crohn's Disease Flare

Description

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

Study Start Date

March 2015

Estimated Completion Date

December 2016

Interventions

  • Drug: Corticosteroid

Specialties

  • Gastroenterology: Inflammatory Bowel Dz
  • Physician Assistant: Gastroenterology

MeSH Terms

  • Crohn Disease

Study ID

Yale University -- 1501015143

Status

Unknown

Trial ID

NCT02392286

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

182

Sponsor

Yale University

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
YaleNew Haven Hospital - New Haven, Connecticut 18.2 miles Loren Laine MD None loren.laine@yale.edu

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