NCT02392286

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 22, 2020

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

March 12, 2015

Results QC Date

December 23, 2019

Last Update Submit

August 5, 2021

Conditions

Crohn's DiseaseInflammatory Bowel Disease

Keywords

Corticosteroid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of Participants With Response at End of 2 Weeks

    2 weeks

  • Number of Participants With Response or Remission at End of 1 Week

    1 week

  • Number of Participants With Response or Remission at End of 4 Weeks

    4 weeks

  • Number of Participants With Response or Remission at End of 12 Weeks

    12 weeks

  • Number of Participants With Corticosteroid-associated Side Effects

    12 weeks

Study Arms (2)

Weight-based

ACTIVE COMPARATOR

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

Drug: Corticosteroid

Fixed dose

ACTIVE COMPARATOR

Corticosteroid dose fixed at equivalent to 40mg prednisone daily.

Drug: Corticosteroid

Interventions

CorticosteroidDRUG

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

Also known as: Prednisone, Methylprednisolone
Fixed doseWeight-based

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Established diagnosis of Crohn's disease
  • Diagnosis of Crohn's flare
  • Decision by treating gastroenterologist to start corticosteroid therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Interventions

Adrenal Cortex HormonesPrednisoneMethylprednisolone

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPrednisolonePregnadienetriols

Results Point of Contact

Title
Dr. Loren Laine
Organization
Yale
loren.laine@yale.edu
203-785-7312

Study Officials

  • Loren Laine, MD

    Yale University, Section of Digestive Diseases

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 18, 2015

Study Start

March 1, 2015

Primary Completion

December 19, 2016

Study Completion

December 19, 2016

Last Updated

August 9, 2021

Results First Posted

January 22, 2020

Record last verified: 2021-08

Locations

US(1)