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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01030809
First received: December 9, 2009
Last updated: March 19, 2014
Last verified: March 2014

December 9, 2009
March 19, 2014
January 2010
September 2013   (final data collection date for primary outcome measure)
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 ]
Proportion of patients in remission at the end of the 12 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: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01030809 on ClinicalTrials.gov Archive Site
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 ]
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: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trial of a Treatment Algorithm for the Management of Crohn's Disease
A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
Other: Treatment Algorithm for Crohn's Disease
Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.
  • 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.
    Intervention: Other: Treatment Algorithm for Crohn's Disease
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1999
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01030809
RP0901
No
University of Western Ontario, Canada
University of Western Ontario, Canada
Abbott
Principal Investigator: Brian G Feagan, MD Robarts Research Institute - University of Western Ontario
University of Western Ontario, Canada
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP