Corticosteroid Dosage for Crohn's Disease Flare

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Crohn's Disease, Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: Corticosteroid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corticosteroid