Corticosteroid Dosage for Crohn's Disease Flare

Phase 4

Terminated

• Conditions: Crohn's Disease; Inflammatory Bowel Disease
• Interventions: Drug: Corticosteroid

• Registration Number: NCT02392286
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-18
• Primary Completion: 2016-12-19
• Study Completion: 2016-12-19
• Results First Submitted: 2019-12-23
• Results First Submitted QC: 2020-01-13
• Results First Posted: 2020-01-22
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Age ≥ 18
• Established diagnosis of Crohn's disease
• Diagnosis of Crohn's flare
• Decision by treating gastroenterologist to start corticosteroid therapy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight-based	Corticosteroid	Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Fixed dose	Corticosteroid	Corticosteroid dose fixed at equivalent to 40mg prednisone daily.

Primary Outcome Measures

Name	Time	Method
Number of Participants in Remission at End of 2 Weeks	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

Name	Time	Method
Number of Participants With Response or Remission at End of 12 Weeks	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 Response at End of 2 Weeks	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	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	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 Corticosteroid-associated Side Effects	12 weeks	Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias.

Trial Locations

Locations (1)

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States