Corticosteroid Dosage for Crohn's Disease Flare

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02392286
• Other study ID #: 1501015143
• Status: Terminated
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: December 19, 2016

Study information

• Verified date: August 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 19, 2016
• Est. primary completion date: December 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• Corticosteroid
Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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