A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Yale University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of Participants in Remission at End of 2 Weeks
Study Overview
Brief Summary
Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •Pregnancy
- •Weight <35 kg
Arms & Interventions
Weight-based
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Intervention: Corticosteroid (Drug)
Fixed dose
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Intervention: Corticosteroid (Drug)
Outcomes
Primary Outcomes
Number of Participants in Remission at End of 2 Weeks
Time Frame: 2 weeks
Number of participants with Harvey Bradshaw Index \< 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. \<5 is determined to be remission.
Secondary Outcomes
- Number of Participants With Response or Remission at End of 12 Weeks(12 weeks)
- Number of Participants With Response at End of 2 Weeks(2 weeks)
- Number of Participants With Response or Remission at End of 1 Week(1 week)
- Number of Participants With Response or Remission at End of 4 Weeks(4 weeks)
- Number of Participants With Corticosteroid-associated Side Effects(12 weeks)