Corticosteroid Dosage for Crohn's Disease Flare
| Status: | Recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2018 |
| Start Date: | March 2015 |
| End Date: | December 2019 |
| Contact: | Loren Laine, MD |
| Email: | loren.laine@yale.edu |
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
Prospective randomized comparative effectiveness trial designed to compare fixed dosing and
weight-based dosing of corticosteroids in patients with Crohn's disease flares.
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.
rate than fixed corticosteroid dosage.
- Determine if weight-based corticosteroid is associated with greater rate of adverse
events than fixed corticosteroid dosage.
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
We found this trial at
1
site
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
Click here to add this to my saved trials
