Back to resultsCorticosteroid Dosage for Crohn's Disease Flare
Primary Purpose
Crohn's Disease, Inflammatory Bowel Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Corticosteroid
Eligibility 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
Sites / Locations
- Yale-New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Weight-based
Fixed dose
Arm Description
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02392286
Brief Title
Corticosteroid Dosage for Crohn's Disease Flare
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
insufficient enrollment
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
December 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Inflammatory Bowel Disease
Keywords
Corticosteroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight-based
Arm Type
Active Comparator
Arm Description
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Arm Title
Fixed dose
Arm Type
Active Comparator
Arm Description
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
Prednisone, Methylprednisolone
Intervention Description
Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
Primary Outcome Measure Information:
Title
Number of Participants in Remission at End of 2 Weeks
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Response at End of 2 Weeks
Description
Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks
Time Frame
2 weeks
Title
Number of Participants With Response or Remission at End of 1 Week
Description
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
Time Frame
1 week
Title
Number of Participants With Response or Remission at End of 4 Weeks
Description
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
Time Frame
4 weeks
Title
Number of Participants With Response or Remission at End of 12 Weeks
Description
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
Time Frame
12 weeks
Title
Number of Participants With Corticosteroid-associated Side Effects
Description
Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loren Laine, MD
Organizational Affiliation
Yale University, Section of Digestive Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
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Corticosteroid Dosage for Crohn's Disease Flare
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