Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Corticosteroid Dosage for Crohn's Disease Flare

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02392286
Recruitment Status : Terminated (insufficient enrollment)
First Posted : March 18, 2015
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Inflammatory Bowel Disease Drug: Corticosteroid Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 19, 2016
Actual Study Completion Date : December 19, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Active Comparator: Weight-based
Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily.
Drug: Corticosteroid
Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
Other Names:
  • Prednisone
  • Methylprednisolone

Active Comparator: Fixed dose
Corticosteroid dose fixed at equivalent to 40mg prednisone daily.
Drug: Corticosteroid
Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
Other Names:
  • Prednisone
  • Methylprednisolone




Primary Outcome Measures :
  1. Number of Participants in Remission at End of 2 Weeks [ Time Frame: 2 weeks ]
    Number of participants with Harvey Bradshaw Index < 5 at end of 2 weeks


Secondary Outcome Measures :
  1. Number of Participants With Response at End of 2 Weeks [ Time Frame: 2 weeks ]
    Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks

  2. Number of Participants With Response or Remission at End of 1 Week [ Time Frame: 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

  3. Number of Participants With Response or Remission at End of 4 Weeks [ Time Frame: 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. Number of Participants With Response or Remission at End of 12 Weeks [ Time Frame: 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

  5. Number of Participants With Corticosteroid-associated Side Effects [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392286


Locations
Layout table for location information
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Layout table for investigator information
Principal Investigator: Loren Laine, MD Yale University, Section of Digestive Diseases
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02392286    
Other Study ID Numbers: 1501015143
First Posted: March 18, 2015    Key Record Dates
Results First Posted: January 22, 2020
Last Update Posted: January 22, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Yale University:
Corticosteroid
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Prednisone
Methylprednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents