Corticosteroid Dosage for Crohn's Disease Flare

Phase 4TerminatedNCT02392286

Yale University15 enrolled

Overview

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

* 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn's Disease Inflammatory Bowel Disease

Interventions

CorticosteroidDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Yale-New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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