Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy

Phase 4

Completed

• Conditions: Crohn's Disease
• Interventions: Other: Conventional Step-care Algorithm; Other: Enhanced Treatment Algorithm

• Registration Number: NCT01698307
• Lead Sponsor: Alimentiv Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Study Start: 2014-03-28
• Primary Completion: 2020-04-16
• Study Completion: 2020-04-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1095

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Step-care Algorithm	Conventional Step-care Algorithm	Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).
Enhanced Treatment Algorithm	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.

Primary Outcome Measures

Name	Time	Method
Risk of Crohn's Disease-related complications at two years	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.

Secondary Outcome Measures

Name	Time	Method
Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.	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.
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.	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.

Trial Locations

Locations (22)

Oravec Medicine Professional Corporation; 🇨🇦 Oshawa, Ontario, Canada

Louisiana Research Center, LLC; 🇺🇸 Shreveport, Louisiana, United States

Asheville Gastroenterology Associates, PA; 🇺🇸 Asheville, North Carolina, United States

The Royal Hampshire County Hospital; 🇬🇧 Winchester, Hampshire, United Kingdom

Verein fur Wissenschaft und Fortbildung; 🇩🇪 Oldenburg, Lower Saxony, Germany

Sudbury Endoscopy Center; 🇨🇦 Sudbury, Ontario, Canada

The Office of Dr. Pierre Laflamme; 🇨🇦 Saint-Charles-Borromée, Quebec, Canada

Praxis fur Gastroenterologie am Bayerischen Platz; 🇩🇪 Berlin, Germany

Oxford University Hospitals NHS Foundation - John Radcliffe Hospital; 🇬🇧 Headington, Oxford, United Kingdom

University Hospital Coventry; 🇬🇧 Coventry, West Midlands, United Kingdom

Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, Berkshire, United Kingdom

Scott and White Memorial Hospital; 🇺🇸 Temple, Texas, United States

New Cross Hospital - Royal Wolverhampton NHS Trust; 🇬🇧 Wolverhampton, West Midlands, United Kingdom

The Royal Bournemouth Hospital; 🇬🇧 Bournemouth, Dorset, United Kingdom

Dr. Fashir Medical Inc.; 🇨🇦 Sydney, Nova Scotia, Canada

S. and T. Shulman Medicine Professional Corporation; 🇨🇦 North Bay, Ontario, Canada

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Gastroenterologie Eppendorfer Baum; 🇩🇪 Hamburg, Germany

The Office of Dr. Bruce Musgrave; 🇨🇦 Kentville, Nova Scotia, Canada

Carle Foundation Hospital; 🇺🇸 Urbana, Illinois, United States

Duane Sheppard, GI Inc.; 🇨🇦 Dartmouth, Nova Scotia, Canada