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COMPASS-CD: A Study of CDPATH™ to Help Manage and Treat Crohn's Disease

Sponsor
Takeda (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04809363
Collaborator
(none)
200
Enrollment
43
Locations
1
Arm
59
Anticipated Duration (Months)
4.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CDPATH™
  • Other: Blood Draw
 Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool
Actual Study Start Date :
Jun 25, 2021
Anticipated Primary Completion Date :
May 26, 2023
Anticipated Study Completion Date :
May 26, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: CDPATH™

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.

Other: CDPATH™
Crohn's disease risk prediction tool.
Other Names:
  • PROSPECT

    • Other: Blood Draw
    Three blood samples will be drawn.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results [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.

    Secondary Outcome Measures

    1. Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category [Up to 36 months]

      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.

    2. Change From Baseline in Decisional Conflict Scale (DCS) Score [Baseline, then every 6 months up to 36 months]

      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.

    3. Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score [Baseline, then every 6 months up to 36 months]

      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).

    4. Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score [Baseline, then every 6 months up to 36 months]

      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).

    5. Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool [Up to 36 months]

      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.

    6. Number of Participants with Clinical Outcomes [Up to 36 months]

      Participants with clinical outcomes describing the disease burden based on treatment path and controlling for risk strata will be reported.

    7. Percentage of Participants with Healthcare Resource Utilization [Up to 36 months]

      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.).

    8. Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATH™ Tool [First assessment (6 months after HCPs first enrolled participant) up to HCP leaves the study or the study ends (up to 36 months)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Arthritis & Rheumatology Research, PLLC Phoenix Arizona United States 85032
    2 Care Access Research LLC Berkeley California United States 94705
    3 University of Southern California Medical Center Irvine California United States 92618
    4 VA Loma Linda Healthcare System Loma Linda California United States 92354
    5 United Medical Doctors Los Alamitos California United States 90720
    6 UCLA Medical Center Gastro Los Angeles California United States 90024
    7 University of California at Irvine Medical Center Orange California United States 92868
    8 Kaiser Permanate of Colorado Englewood Colorado United States 80113
    9 Medical Research Center of Connecticut, LLC Hamden Connecticut United States 06518
    10 West Central Gastroenterology d/b/a Gastro Florida Clearwater Florida United States 33762
    11 Gastroenterology Associates of Pensacola, PA Pensacola Florida United States 32503
    12 Grand Teton Research Group, PLL Idaho Falls Idaho United States 83404
    13 University of Chicago Medical Center Chicago Illinois United States 60637
    14 Rockford Gastroenterology Associates, Ltd. Rockford Illinois United States 61107
    15 Indiana University Indianapolis Indiana United States 46202
    16 Iowa Digestive Disease Center Clive Iowa United States 50325
    17 University Of Iowa Hospital and Clinics Iowa City Iowa United States 52242
    18 University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas United States 66205
    19 Louisiana Research Center, LLC Shreveport Louisiana United States 71105
    20 Lahey Clinic Inc. Burlington Massachusetts United States 01805
    21 Center for Digestive Health Troy Michigan United States 48098
    22 Atlantic Digestive Health Institute at Morristown Morristown New Jersey United States 07960
    23 University of New Mexico Albuquerque New Mexico United States 87131
    24 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
    25 Dayton Gastroenterology, Inc Dayton Ohio United States 45415
    26 Digestive Disease Specialists, Inc. Oklahoma City Oklahoma United States 73122
    27 The Oregon Clinic, P.C. Portland Oregon United States 97220
    28 Allegheny Center for Digestive Health Pittsburgh Pennsylvania United States 15212
    29 University of Pittsburgh Medical Center Health System Pittsburgh Pennsylvania United States 15213
    30 Gastroenterology Associates, PA Greenville South Carolina United States 29615
    31 Vanderbilt University Medical Center Nashville Tennessee United States 37212
    32 The University of Texas at Austin Austin Texas United States 78712
    33 Baylor College of Medicine Houston Texas United States 77030
    34 Pinnacle Clinical Research, PLLC San Antonio Texas United States 78229
    35 Texas Digestive Disease Consultants - Southlake Southlake Texas United States 76092
    36 Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance Southlake Texas United States 76092
    37 Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance Southlake Texas United States 76092
    38 University of Utah Salt Lake City Utah United States 84132
    39 Gastroenterology Associates of Northern Virginia, Ltd. Fairfax Virginia United States 22031
    40 Gastroenterology Associates Lynchburg Virginia United States 24502
    41 Carilion Clinic Roanoke Virginia United States 24014
    42 Washington Gastroenterology Bellevue Washington United States 98405
    43 University of Washington School of Medicine Seattle Washington United States 98195

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT04809363
    Other Study ID Numbers:
    • Vedolizumab-4015
    First Posted:
    Mar 22, 2021
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Takeda
    Drug Therapy
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Nov 16, 2021