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

Crohn's Disease Clinical Trial

— REACT  

Official title:

A Cluster Randomized Controlled Trial of a Treatment Algorithm for the Management of Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030809
• Other study ID #: RP0901
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2009
• Last updated: March 19, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: University of Western Ontario, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1999
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• Treatment Algorithm for Crohn's Disease
Practitioners assigned to the intervention arm will be educated on the use of the treatment algorithm.

Locations

Country	Name	City	State
Canada	Robarts Clinical Trials, Robarts Research Institute	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Ontario, Canada	Abbott

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No