Corticosteroid Dosage for Crohn's Disease Flare

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-12-19

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.

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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.

Conditions

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Crohn's Disease Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Weight-based

Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type DRUG

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

Fixed dose

Corticosteroid dose fixed at equivalent to 40mg prednisone daily.

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type DRUG

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

Interventions

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Corticosteroid

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

Intervention Type DRUG

Other Intervention Names

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Prednisone Methylprednisolone

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes