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

University of Western Ontario, Canada

Status and phase: Completed; Phase 4

Conditions: Crohn's Disease

Treatments: Other: Treatment Algorithm for Crohn's Disease

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01030809

RP0901

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,999 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,999 participants in 2 patient groups

Usual Care practice

No Intervention group

Description:

Patients managed according to usual care practices

Treatment Algorithm

Active Comparator group

Description:

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

Treatment:

Other: Treatment Algorithm for Crohn's Disease