Completed

REACT2A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Enhanced Treatment Algorithm

+ Conventional Step-care Algorithm

Other
Who is being recruted

Digestive System Diseases+3

+ Gastroenteritis

+ Gastrointestinal Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: March 2014
See protocol details

Summary

Principal SponsorAlimentiv Inc.
Last updated: November 11, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: March 28, 2014

Actual date on which the first participant was enrolled.

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.

NCT01698307
Principal SponsorAlimentiv Inc.
Last updated: November 11, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

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

1095 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel DiseasesCrohn Disease

Criteria

3 inclusion criteria required to participate
Documented diagnosis of CD
Willing to utilize study supply of adalimumab provided in syringe format, if indicated according to treatment algorithm
Written informed consent must be obtained and documented
5 exclusion criteria prevent from participating
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
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
Diagnosis of short bowel syndrome
Latex allergy or other conditions in which adalimumab syringes are contraindicated
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 22 locations

Georgetown University Hospital

Washington D.C., United StatesOpen Georgetown University Hospital in Google Maps

Carle Foundation Hospital

Urbana, United States

Louisiana Research Center, LLC

Shreveport, United States

Asheville Gastroenterology Associates, PA

Asheville, United States
Completed22 Study Centers