Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy (REACT2)

November 4, 2021 updated by: Alimentiv Inc.

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

Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1095

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada, B2Y 4G8
        • Duane Sheppard, GI Inc.
      • Kentville, Nova Scotia, Canada, B4N 0A3
        • The Office of Dr. Bruce Musgrave
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Dr. Fashir Medical Inc.
    • Ontario
      • North Bay, Ontario, Canada, P1B 2H3
        • S. and T. Shulman Medicine Professional Corporation
      • Oshawa, Ontario, Canada, L1J 2J9
        • Oravec Medicine Professional Corporation
      • Sudbury, Ontario, Canada, P3C 5K6
        • Sudbury Endoscopy Center
    • Quebec
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2C3
        • The Office of Dr. Pierre Laflamme
  • Germany
      • Berlin, Germany, 10825
        • Praxis fur Gastroenterologie am Bayerischen Platz
      • Hamburg, Germany, 20249
        • Gastroenterologie Eppendorfer Baum
    • Lower Saxony
      • Oldenburg, Lower Saxony, Germany, 26123
        • Verein fur Wissenschaft und Fortbildung
  • United Kingdom
      • Nottingham, United Kingdom, D1406
        • Nottingham University Hospitals NHS Trust
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 5AN
        • Royal Berkshire NHS foundation trust
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • The Royal Bournemouth Hospital
    • Hampshire
      • Winchester, Hampshire, United Kingdom, SO2 5DG
        • The Royal Hampshire County Hospital
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation - John Radcliffe Hospital
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Wolverhampton, West Midlands, United Kingdom, WV1 0QP
        • New Cross Hospital - Royal Wolverhampton NHS Trust
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, PA
    • Texas
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented diagnosis of CD
  • Written informed consent must be obtained and documented.
  • Willing to utilize study supply of adalimumab provided in syringe format, if indicated according to treatment algorithm.

Exclusion Criteria:

  • Any conditions (e.g., history of alcohol or substance abuse) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures.
  • Latex allergy or other conditions in which adalimumab syringes are contraindicated
  • Currently participating, or planning to participate in a study involving investigational product within 24 months that may interfere with the patient's ability to comply with study procedures.
  • Previously failed all classes of tumor necrosis factor (TNF) antagonists for the treatment of CD.
  • Diagnosis of short bowel syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Enhanced Treatment Algorithm
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
Other: Enhanced Treatment Algorithm
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
Other Names:
  • Adalimumab
OTHER: Conventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).
Other: Conventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of Crohn's Disease-related complications at two years
Time Frame: 2 years
Crohn''s Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.
Time Frame: six months, 12 months
Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.
six months, 12 months
Time to first Crohn's Disease-related complication, first Crohn's Disease-related hospitalizations, and first all cause hospitalizations at 6 months and 12 months.
Time Frame: six months, 12 months
Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.
six months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients at one year and two years who are in Deep Remission without disease progression
Time Frame: 1 year, 2 years
Disease progression is defined as the de novo development of strictures or fistula, the occurrence of an intra-abdominal abscess, or surgery for Crohn's Disease (resection, bypass, stricturoplasty).
1 year, 2 years
Proportion of patients at one year and two years who are in Deep Remission
Time Frame: 1 year, 2 years
Deep remission defined as a Harvey-Bradshaw Index (HBI) less than or equal to 4, no steriods for the treatment of Crohn's Disease, and normal C-reactive protein
1 year, 2 years
Proportion of patients at one year and 2 years who are in Clinical Remission
Time Frame: 1 year, 2 years
Clinical remission defined as an Harvey-Bradshaw Index (HBI) of equal to or less than 4.
1 year, 2 years
Change in C-reactive protein
Time Frame: 6 months, 1 year, 2 years
6 months, 1 year, 2 years
Change in health related QoL, patient and physician global rating
Time Frame: 6 months, 1 year, 2 years
The EuroQoL instrument [EQ-5D] will be used to measure quality of life.
6 months, 1 year, 2 years
Patient and physician satisfaction
Time Frame: 2 years
At the completion of study participation, subjects and physicians in both treatment groups will be asked to complete a satisfaction questionnaire regarding the information provided and their overall satisfaction with the approach to the management of CD. The physicians will also be asked if they would recommend the CD treatment algorithm to their colleagues, and if they think it would be feasible to sustain this algorithm within their practice setting.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alimentiv Inc.

Investigators

  • Principal Investigator: Brian G Feagan, MD, Robarts Clinical Trials - Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2014

Primary Completion (ACTUAL)

April 16, 2020

Study Completion (ACTUAL)

April 16, 2020

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (ESTIMATE)

October 2, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP1202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study is site randomization not subject.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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