Clinical trial NCT04809363: A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
Official title: A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant's risk profile and to have discussions with their doctor about the potential path of their Crohn's disease. The number of visits will be decided by the study clinic according to their standard practice.

Detailed description: The tool being tested in this study is called CDPATH™. CDPATH™ is being used to provide a graphical representation of an individual participant's risk of developing a CD-related complication within three years, leveraging known participant risk factors based on clinical, serologic and genetic variables to help people categorize risk who have CD. This study will gather data on the use of the tool in real-world settings to inform practical use of CDPATH™.

The study will enroll approximately 200 patients. Participants and health care providers (HCPs) will be surveyed to understand their satisfaction with the CDPATH™ process and with their treatment choice.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 36 months. Participants will make multiple visits to the HCP's clinic, and data will be collected approximately every six months up to 3 years, based on the timing of routine follow-up appointments for assessment.

Eligibility criteria: Inclusion Criteria:

1. Has an initial diagnosis of CD established within five years prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report (if available).
2. Has agreed to use the CDPATH™ tool.
3. Has reliable access to the internet and is willing to answer electronic patient-reported outcomes (ePROs) throughout the study.

Exclusion Criteria:

1. Has had known complications from CD including but not limited to: bowel stricture, CD-related intra-abdominal abscess, internal penetrating disease (known fistula other than perianal fistula), non-perianal surgery, bowel resection, or stricturoplasty. A perianal fistula or abscess without other signs of penetrating disease is allowed.
2. Has had any non-CD-related abdominal surgery.
3. Has received investigational biologic or nonbiologic agents for the treatment of CD in an investigational protocol. Approved biologic or nonbiologic agents for CD are allowed.
4. Has previously used CDPATH™ or PROSPECT results to assess CD risk for complications.

Primary outcomes:
measure: Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results
timeFrame: Baseline (Day 1)
Secondary outcomes:
measure: Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category
timeFrame: Up to 36 months
measure: Change From Baseline in Decisional Conflict Scale (DCS) Score
timeFrame: Baseline, then every 6 months up to 36 months
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score
timeFrame: Baseline, then every 6 months up to 36 months
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score
timeFrame: Baseline, then every 6 months up to 36 months
measure: Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool
timeFrame: Up to 36 months
measure: Number of Participants with Clinical Outcomes
timeFrame: Up to 36 months
measure: Percentage of Participants with Healthcare Resource Utilization
timeFrame: Up to 36 months
measure: Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATH™ Tool
timeFrame: First assessment (6 months after HCPs first enrolled participant) up to HCP leaves the study or the study ends (up to 36 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Newport Beach
country: United States
facility: University of Southern California Medical Center
state: California
city: Orange
country: United States
facility: Clinnova Research Solutions
state: California
city: Orange
country: United States
facility: University of California at Irvine Medical Center
state: California
city: Aurora
country: United States
facility: Kaiser Permanate of Colorado
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Clearwater
country: United States
facility: West Central Gastroenterology d/b/a Gastro Florida
state: Florida
city: Pensacola
country: United States
facility: Gastroenterology Associates of Pensacola, PA
state: Florida
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLL
state: Idaho
city: Arlington Heights
country: United States
facility: GI Alliance
state: Illinois
city: Gurnee
country: United States
facility: GI Alliance
state: Illinois
city: Northbrook
country: United States
facility: Comprehensive Gastrointestinal Health
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, Ltd.
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Baton Rouge
country: United States
facility: GI Alliance - Baton Rouge
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic Inc. - PARENT ACCOUNT
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd
state: Ohio
city: Dayton
country: United States
facility: Dayton Gastroenterology, Inc
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic, P.C.
state: Oregon
city: Camp Hill
country: United States
facility: Susquehanna Research Group, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Center for Digestive Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Health System
state: Pennsylvania
city: Uniontown
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Summerville
country: United States
facility: Palmetto Primary Care Physician Division of Gastroenterology
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Medical Center, LLC
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Southlake
country: United States
facility: GI Alliance - Southlake
state: Texas
city: Ogden
country: United States
facility: Care Access Research Berkley
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Fairfax
country: United States
facility: GCGA Physicians LLC
state: Virginia
city: Lynchburg
country: United States
facility: Gastroenterology Associates
state: Virginia
city: Bellevue
country: United States
facility: GI Alliance
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: