Corticosteroid Dosage for Crohn's Disease Flare

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

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

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease; Inflammatory Bowel Disease
• Intervention / Treatment: Drug: Corticosteroid

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Weight-based; Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.	Drug: Corticosteroid; Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.; Other Names: Methylprednisolone; Prednisone
Active Comparator: Fixed dose; Corticosteroid dose fixed at equivalent to 40mg prednisone daily.	Drug: Corticosteroid; Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.; Other Names: Methylprednisolone; Prednisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in Remission at End of 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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Response at End of 2 Weeks	Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks	2 weeks
Number of Participants With Response or Remission at End of 1 Week	Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 1 week	1 week
Number of Participants With Response or Remission at End of 4 Weeks	Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 4 weeks	4 weeks
Number of Participants With Response or Remission at End of 12 Weeks	Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 12 weeks	12 weeks
Number of Participants With Corticosteroid-associated Side Effects	Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias.	12 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Loren Laine, MD, Yale University, Section of Digestive Diseases

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 19, 2016
• Study Completion (Actual): December 19, 2016

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 12, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Corticosteroid
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Methylprednisolone; Prednisone
• Other Study ID Numbers: 1501015143

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes