A Study of CDPATH™ to Help Manage and Treat Crohn's Disease

Crohn's Disease Clinical Trial

— COMPASS-CD  

Official title:

A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04809363
• Other study ID #: Vedolizumab-4015
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 25, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• CDPATH™
Crohn's disease risk prediction tool.
• Blood Draw
Three blood samples will be drawn.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	GI Alliance	Arlington Heights	Illinois
United States	Kaiser Permanate of Colorado	Aurora	Colorado
United States	The University of Texas at Austin	Austin	Texas
United States	GI Alliance - Baton Rouge	Baton Rouge	Louisiana
United States	Clinical Inquest Center Ltd	Beavercreek	Ohio
United States	GI Alliance	Bellevue	Washington
United States	Lahey Clinic Inc. - PARENT ACCOUNT	Burlington	Massachusetts
United States	Susquehanna Research Group, LLC	Camp Hill	Pennsylvania
United States	West Central Gastroenterology d/b/a Gastro Florida	Clearwater	Florida
United States	Iowa Digestive Disease Center	Clive	Iowa
United States	Gastro Center of Maryland	Columbia	Maryland
United States	Dayton Gastroenterology, Inc	Dayton	Ohio
United States	GCGA Physicians LLC	Fairfax	Virginia
United States	GI Alliance	Gurnee	Illinois
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	Grand Teton Research Group, PLL	Idaho Falls	Idaho
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	Gastroenterology Associates	Lynchburg	Virginia
United States	United Medical Doctors	Murrieta	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Lenox Hill Hospital	New York	New York
United States	University of Southern California Medical Center	Newport Beach	California
United States	Comprehensive Gastrointestinal Health	Northbrook	Illinois
United States	Care Access Research Berkley	Ogden	Utah
United States	Clinnova Research Solutions	Orange	California
United States	University of California at Irvine Medical Center	Orange	California
United States	Gastroenterology Associates of Pensacola, PA	Pensacola	Florida
United States	Arizona Arthritis & Rheumatology Research, PLLC	Phoenix	Arizona
United States	Allegheny Center for Digestive Health	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center Health System	Pittsburgh	Pennsylvania
United States	The Oregon Clinic, P.C.	Portland	Oregon
United States	Rapid City Medical Center, LLC	Rapid City	South Dakota
United States	Rockford Gastroenterology Associates, Ltd.	Rockford	Illinois
United States	University of Utah	Salt Lake City	Utah
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	GI Alliance - Southlake	Southlake	Texas
United States	Palmetto Primary Care Physician Division of Gastroenterology	Summerville	South Carolina
United States	Frontier Clinical Research, LLC	Uniontown	Pennsylvania
United States	UMASS Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results	The risk profile of an individual participant with CD is the output of the CDPATH™ tool. Categories for CD includes low, medium, high risk of developing a CD complication within 3 years.	Baseline (Day 1)
Secondary	Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category	Treatment path (i.e., sequence over time) and choice, by low, medium and high risk, will be chosen to characterize treatment path and choice based on risk stratification.	Up to 36 months
Secondary	Change From Baseline in Decisional Conflict Scale (DCS) Score	DCS is a validated electronic patient-reported outcome (ePRO) collected via electronically administered patient surveys. It measures personal perceptions of the following responses: uncertainty in choosing options, modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making, and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. DCS involves answering 11 questions of PRO, of which 10 questions can be answered as yes (score = 0) or unsure (score = 2) or no (score =4). The total score will range from 0 to 40. Higher score indicates higher decisional conflict.	Baseline, then every 6 months up to 36 months
Secondary	Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score	WPAI-CD is a validated ePRO collected via electronically administered patient surveys. It consists of six questions that evaluate 4 domain scores: absenteeism (i.e., work time missed), presenteeism (i.e., reduced work productivity), overall work impairment, and activity impairment. Scores are expressed as a percentage of impairment, where higher scores indicate greater impairment and reduced productivity. The total score ranges from 0 (no impairment) to 100% (total loss of work productivity).	Baseline, then every 6 months up to 36 months
Secondary	Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score	PROMIS Global Health scale is a validated ePRO collected via electronically administered patient surveys. It is a 10-item PRO measuring the overall evaluation of one's physical and mental health. The total score ranges from 0 to 100. The final score will be represented by the T-score metric, in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. A higher PROMIS T-score represents more of the concept being measured (higher Global Health score indicate better health).	Baseline, then every 6 months up to 36 months
Secondary	Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool	Participant's satisfaction and experience with the CDPATH™ tool will be assessed based on 15 questions. Negative responses/lower score to/in these questions indicates less satisfaction whereas positive responses/higher score indicates satisfaction with the tool.	Up to 36 months
Secondary	Number of Participants with Clinical Outcomes	Participants with clinical outcomes describing the disease burden based on treatment path and controlling for risk strata will be reported.	Up to 36 months
Secondary	Percentage of Participants with Healthcare Resource Utilization	Healthcare resource includes healthcare provider (HCP) visits/referrals, visit to emergency room, hospitalizations, surgery, new CD-related complications, and diagnostic evaluations (e.g., imaging, colonoscopy, etc.).	Up to 36 months
Secondary	Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATH™ Tool	HCP-reported CDPATH™ satisfaction data will be collected directly from HCPs via electronically administered HCP surveys and entered into the eCRF. HCPs will be queried regarding their satisfaction and experience with the general process, the ease of incorporating the tool in their everyday practice, and the impact of the tool on their treatment recommendations and participant communications. For the 6 questions, HCP will rate on 1-5 scale where, 1=strongly disagree and 5=strongly agree. For remaining 4 questions, written feedback from HCP will be consider. Overall positive responses will indicate higher feasibility and usability.	First assessment (6 months after HCPs first enrolled participant) up to HCP leaves the study or the study ends (up to 36 months)

External Links

•   To obtain more information on the study, click on this link.