NCT01030809

Brief Summary

Assess if the implementation of a treatment algorithm will improve the management of Crohn's disease (CD) in comparison to usual care based gastroenterology practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,999

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

3.7 years

First QC Date

December 9, 2009

Last Update Submit

March 19, 2014

Conditions

Crohn's Disease

Keywords

Crohn's diseasecommunity based gastroenterology practices Canada and BelgiumCluster randomization controlled trialRemissionCorticosteroidsDocumented diagnosis of Crohn's disease

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients in remission at the end of the 24 month followup period. Remission is defined as a HBS< or = 4 without use of steroids for the treatment of CD. the primary analysis will be performed at the level of the practice.

    24 months

Secondary Outcomes (1)

  • Proportion of patients in remission over study, change in mean HBS; use of CD meds, occurrence of surgery/hospitalization for CD and complications, patients' health related QOL measured by SF-36 & EQ-5D; physician/patient satisfaction with therapy.

    24 months

Study Arms (2)

Usual Care practice

NO INTERVENTION

Patients managed according to usual care practices

Treatment Algorithm

ACTIVE COMPARATOR

Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.

Other: Treatment Algorithm for Crohn's Disease

Interventions

Treatment Algorithm for Crohn's DiseaseOTHER

Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.

Treatment Algorithm

Eligibility Criteria

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

You may qualify if:

  • Documented diagnosis of Crohn's disease
  • Able to speak and understand English, French or Flemish
  • Access to a telephone or email/internet service
  • Written informed consent must be obtained and documented

You may not qualify if:

  • Any conditions (e.g., history of alcohol or substance abuse) which in the opinion of the investigator , may interfere with the patients ability to comply with study procedures
  • Participating in other investigational studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robarts Clinical Trials, Robarts Research Institute

London, Ontario, N6A 5K8, Canada

Location

Related Publications (2)

  • Singh S, Stitt LW, Zou G, Khanna R, Dulai PS, Sandborn WJ, Feagan BG, Jairath V. Early combined immunosuppression may be effective and safe in older patients with Crohn's disease: post hoc analysis of REACT. Aliment Pharmacol Ther. 2019 May;49(9):1188-1194. doi: 10.1111/apt.15214. Epub 2019 Mar 19.

    PMID: 30891808DERIVED

  • Khanna R, Bressler B, Levesque BG, Zou G, Stitt LW, Greenberg GR, Panaccione R, Bitton A, Pare P, Vermeire S, D'Haens G, MacIntosh D, Sandborn WJ, Donner A, Vandervoort MK, Morris JC, Feagan BG; REACT Study Investigators. Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial. Lancet. 2015 Nov 7;386(10006):1825-34. doi: 10.1016/S0140-6736(15)00068-9. Epub 2015 Sep 3.

    PMID: 26342731DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Brian G Feagan, MD

    Robarts Research Institute - University of Western Ontario

    PRINCIPAL INVESTIGATOR

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

December 9, 2009

First Posted

December 11, 2009

Study Start

January 1, 2010

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations

CA(1)