Crohn's DiseasePhase 4COMPASS-CDNCT04809363
A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
A Phase 4 study testing CDPATH™ and Blood Draw in people with Crohn's Disease, run by Takeda at 44 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- CDPATH™ and Blood Draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 44 sitesUnited States
- Study dates
- 25 Jun 2021to 27 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Has agreed to use the CDPATH™ tool.
- Has reliable access to the internet and is willing to answer electronic patient-reported outcomes (ePROs) throughout the study.
Who cannot join
- 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.
- Has had any non-CD-related abdominal surgery.
- 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.
- Has previously used CDPATH™ or PROSPECT results to assess CD risk for complications.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
University of New Mexico
Albuquerque, New Mexico, 87131-0001
GI Alliance
Arlington Heights, Illinois, 60005
Kaiser Permanate of Colorado
Aurora, Colorado, 80014
The University of Texas at Austin
Austin, Texas, 78712
GI Alliance - Baton Rouge
Baton Rouge, Louisiana, 70809
Clinical Inquest Center Ltd
Beavercreek, Ohio, 45431
GI Alliance
Bellevue, Washington, 98405
Lahey Clinic Inc. - PARENT ACCOUNT
Burlington, Massachusetts, 01805
Susquehanna Research Group, LLC
Camp Hill, Pennsylvania, 17011
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, 33762
Iowa Digestive Disease Center
Clive, Iowa, 50325
Gastro Center of Maryland
Columbia, Maryland, 21045
Dayton Gastroenterology, Inc
Dayton, Ohio, 45415
GCGA Physicians LLC
Fairfax, Virginia, 22031
GI Alliance
Gurnee, Illinois, 60031
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518
Baylor College of Medicine
Houston, Texas, 77030
Grand Teton Research Group, PLL
Idaho Falls, Idaho, 83404
Indiana University
Indianapolis, Indiana, 46202
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242-1009
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
VA Loma Linda Healthcare System
Loma Linda, California, 92357
Gastroenterology Associates
Lynchburg, Virginia, 24502
United Medical Doctors
Murrieta, California, 92563
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Lenox Hill Hospital
New York, New York, 10075-1850
University of Southern California Medical Center
Newport Beach, California, 92663
Comprehensive Gastrointestinal Health
Northbrook, Illinois, 60062
Care Access Research Berkley
Ogden, Utah, 84403
Clinnova Research Solutions
Orange, California, 92868
University of California at Irvine Medical Center
Orange, California, 92868
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85032
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania, 15213
The Oregon Clinic, P.C.
Portland, Oregon, 97220-9442
Rapid City Medical Center, LLC
Rapid City, South Dakota, 57701
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107
University of Utah
Salt Lake City, Utah, 84132
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
GI Alliance - Southlake
Southlake, Texas, 76092
Palmetto Primary Care Physician Division of Gastroenterology
Summerville, South Carolina, 29486
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool
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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- CDPATH™, Blood Draw
- Keywords
- Drug Therapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDPATH™Other
Also called PROSPECT
Crohn's disease risk prediction tool.
Blood DrawOther
Three blood samples will be drawn.
| Study group | Role | What they receive |
|---|---|---|
| CDPATH™ | Experimental | Participants with CD will be using CDPATH™ tool. Clinical data will be collected via an ongoing registry. Participants and health care provider (HCP)-reported outcomes data will be collected periodically once every 6 months for up to 36 months via electronic surveys. Two baseline blood samples will be collected at screening for CDPATH™ analysis. 1 additional sample will be collected for future potential biomarker analysis. Receives: Other: CDPATH™; Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1)
Secondary outcomes (8)
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.
Measured: Up to 36 months
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.
Measured: Baseline, then every 6 months up to 36 months
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).
Measured: Baseline, then every 6 months up to 36 months
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).
Measured: Baseline, then every 6 months up to 36 months
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.
Measured: Up to 36 months
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.
Measured: Up to 36 months
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.).
Measured: Up to 36 months
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.
Measured: First assessment (6 months after HCPs first enrolled participant) up to HCP leaves the study or the study ends (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start25 Jun 2021
- Primary completion27 Aug 2026
- Study completion27 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809363
- Sponsor's protocol ID
- Vedolizumab-4015
- Acronym
- COMPASS-CD
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool
- ClinicalTrials.gov ID
- NCT04809363
- Acronym / sponsor ID
- COMPASS-CD / Vedolizumab-4015
- Conditions
- Crohn's Disease
- Keywords
- Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 27 Aug 2026 (actual)
- Study completion
- 27 Aug 2026 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDPATH™ | Experimental | Other: CDPATH™, Other: Blood DrawParticipants with CD will be using CDPATH™ tool. Clinical data will be collected via an ongoing registry. Participants and health care provider (HCP)-reported outcomes data will be collected periodically once every 6 months for up to 36 months via electronic surveys. Two baseline blood samples will be collected at screening for CDPATH™ analysis. 1 additional sample will be collected for future potential biomarker analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
- Has agreed to use the CDPATH™ tool.
- Has reliable access to the internet and is willing to answer electronic patient-reported outcomes (ePROs) throughout the study.
Key exclusion criteria (4 listed)
- 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.
- Has had any non-CD-related abdominal surgery.
- 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.
- Has previously used CDPATH™ or PROSPECT results to assess CD risk for complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDPATH™Also: PROSPECTCrohn's disease risk prediction tool. | Other | CDPATH™ |
| Blood DrawThree blood samples will be drawn. | Other | CDPATH™ |
Primary outcome
Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results
Time frame: Baseline (Day 1)
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.
8 secondary outcomes
Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category
Time frame: Up to 36 months
Change From Baseline in Decisional Conflict Scale (DCS) Score
Time frame: Baseline, then every 6 months up to 36 months
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score
Time frame: Baseline, then every 6 months up to 36 months
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score
Time frame: Baseline, then every 6 months up to 36 months
Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool
Time frame: Up to 36 months
Number of Participants with Clinical Outcomes
Time frame: Up to 36 months
Percentage of Participants with Healthcare Resource Utilization
Time frame: Up to 36 months
Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATH™ Tool
Time frame: First assessment (6 months after HCPs first enrolled participant) up to HCP leaves the study or the study ends (up to 36 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CDPATH™ and Blood Draw in people with Crohn's Disease, run by Takeda at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results (time frame: Baseline (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.