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Trial of a Treatment Algorithm for the Management of Crohn's Disease (REACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01030809
First received: December 9, 2009
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
 Other: Treatment Algorithm for Crohn's Disease
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • 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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2400
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care practice
Patients managed according to usual care practices
Active Comparator: Treatment Algorithm
Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.
 Other: Treatment Algorithm for Crohn's Disease
Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.

Detailed Description:

Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During disease exacerbations, pharmacological or surgical intervention is usually needed to re-establish remission. Ideally, strategies should be employed to maintain patients in long-term remission while minimizing exposure to corticosteroids and reduce therapy-related toxicity.

Nevertheless, in reality many patients with CD do not receive effective therapy and their disease often remains active, leading to uncontrolled inflammation and complications from either the underlying disease or corticosteroids. Although treatment guidelines exist, they do not adequately define treatment goals and the duration of treatment cycles is not specified Optimizing outcomes in CD requires rapid control of inflammation. Intuitively, persistent inflammation leads to persistent symptoms, tissue damage, and disease-related complications. Conventional therapy is frequently ineffective in moderate to severe CD, and is often continued for a prolonged time. Consequently, many patients are under-treated. An alternate strategy that minimizes the use of corticosteroids and encourages the earlier use of immunosuppressive agents and tumour necrosis factor (TNF) antagonists may be optimal. However it is unknown whether this approach is superior to usual care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030809

Locations
Canada, Ontario
Robarts Clinical Trials, Robarts Research Institute
London, Ontario, Canada, N6A 5K8
Sponsors and Collaborators
University of Western Ontario, Canada
Abbott
Investigators
Principal Investigator: Brian G Feagan, MD Robarts Research Institute - University of Western Ontario
  More Information

No publications provided

Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01030809     History of Changes
Other Study ID Numbers: RP0901
Study First Received: December 9, 2009
Last Updated: February 6, 2013
Health Authority: Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University of Western Ontario, Canada:
Crohn's disease
community based gastroenterology practices Canada and Belgium
Cluster randomization controlled trial
 Remission
Corticosteroids
Documented diagnosis of Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on June 17, 2013