Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy

Phase 4

Completed

• Conditions: Crohn's Disease

• 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.

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

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

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

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

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

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

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

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

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

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

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

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