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Completed

NCT Number: NCT01030809

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Robarts Clinical Trials, Robarts Research Institute

London, Ontario, N6A 5K8, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment Algorithm for Crohn's Disease

Other

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

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.

    Time frame: 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.

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University of Western Ontario, Canada

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Acronym: REACT

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2009
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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