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

Primary Purpose

Crohn's Disease

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CDPATH™
Blood Draw
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn's Disease focused on measuring Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Arthritis & Rheumatology Research, PLLCRecruiting
  • VA Loma Linda Healthcare SystemRecruiting
  • United Medical DoctorsRecruiting
  • University of Southern California Medical CenterRecruiting
  • Clinnova ResearchRecruiting
  • University of California at Irvine Medical CenterRecruiting
  • Kaiser Permanate of ColoradoRecruiting
  • Medical Research Center of Connecticut, LLCRecruiting
  • West Central Gastroenterology d/b/a Gastro FloridaRecruiting
  • Gastroenterology Associates of Pensacola, PARecruiting
  • West Central Gastroenterology d/b/a Gastro FloridaRecruiting
  • Emory Healthcare
  • Grand Teton Research Group, PLLRecruiting
  • GI AllianceRecruiting
  • University of Chicago Medical Center
  • GI AllianceRecruiting
  • Comprehensive Gastrointestinal HealthRecruiting
  • Rockford Gastroenterology Associates, Ltd.Recruiting
  • Indiana UniversityRecruiting
  • Iowa Digestive Disease CenterRecruiting
  • University Of Iowa Hospital and ClinicsRecruiting
  • University of Kansas Medical Center Research Institute, Inc.Recruiting
  • GI Alliance - Baton RougeRecruiting
  • Louisiana Research Center, LLCRecruiting
  • University of Maryland School of Medicine.
  • Gastro Center of MarylandRecruiting
  • Lahey Clinic Inc. - PARENT ACCOUNTRecruiting
  • UMASS Memorial Medical CenterRecruiting
  • Digestive Health to Clinical Research Institute of Michigan (CRIM)Recruiting
  • Gastroenterology Associates of Western Michigan, P.L.C.Recruiting
  • BVL Clinical ResearchRecruiting
  • University of New MexicoRecruiting
  • Lenox Hill HospitalRecruiting
  • Wake Forest Baptist Health
  • Clinical Inquest Center LtdRecruiting
  • Dayton Gastroenterology, IncRecruiting
  • Great Lakes Gastroenterology Research, LLCRecruiting
  • Digestive Disease Specialists, Inc.Recruiting
  • The Oregon Clinic, P.C.Recruiting
  • Susquehanna Research Group, LLCRecruiting
  • Hospital of the University of Pennsylvania
  • Allegheny Center for Digestive HealthRecruiting
  • University of Pittsburgh Medical Center Health SystemRecruiting
  • Frontier Clinical Research, LLC
  • Palmetto Primary Care Physician Division of GastroenterologyRecruiting
  • Rapid City Medical Center, LLCRecruiting
  • Vanderbilt University Medical Center
  • The University of Texas at AustinRecruiting
  • Baylor College of MedicineRecruiting
  • GI Alliance - SouthlakeRecruiting
  • Care Access Research LLCRecruiting
  • University of UtahRecruiting
  • GCGA Physicians LLCRecruiting
  • Gastroenterology AssociatesRecruiting
  • Washington GastroenterologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CDPATH™

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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).
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.
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.
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.).
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.

Full Information

First Posted
March 19, 2021
Last Updated
August 23, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT04809363
Brief Title
A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
Acronym
COMPASS-CD
Official Title
A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CDPATH™
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CDPATH™
Other Intervention Name(s)
PROSPECT
Intervention Description
Crohn's disease risk prediction tool.
Intervention Type
Other
Intervention Name(s)
Blood Draw
Intervention Description
Three blood samples will be drawn.
Primary Outcome Measure Information:
Title
Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATH™ Tool Results
Description
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.
Time Frame
Baseline (Day 1)
Secondary Outcome Measure Information:
Title
Percentage of Participants with Specific Treatment Path and Choice Based on CDPATH™ Tool, Stratified According to Risk Category
Description
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.
Time Frame
Up to 36 months
Title
Change From Baseline in Decisional Conflict Scale (DCS) Score
Description
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.
Time Frame
Baseline, then every 6 months up to 36 months
Title
Change From Baseline in Work Productivity and Activity Impairment Questionnaire - CD Version (WPAI-CD) Score
Description
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).
Time Frame
Baseline, then every 6 months up to 36 months
Title
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Score
Description
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).
Time Frame
Baseline, then every 6 months up to 36 months
Title
Patient-Reported Satisfaction and Experience Score with the CDPATH™ Tool
Description
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.
Time Frame
Up to 36 months
Title
Number of Participants with Clinical Outcomes
Description
Participants with clinical outcomes describing the disease burden based on treatment path and controlling for risk strata will be reported.
Time Frame
Up to 36 months
Title
Percentage of Participants with Healthcare Resource Utilization
Description
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.).
Time Frame
Up to 36 months
Title
Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATH™ Tool
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
480-626-6650
Email
asoloman.research@azarthritis.com
First Name & Middle Initial & Last Name & Degree
Amy Soloman
Facility Name
VA Loma Linda Healthcare System
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
909-825-7084
Email
muhammad.hammami@va.gov
First Name & Middle Initial & Last Name & Degree
Muhammad Hammami
Facility Name
United Medical Doctors
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
562-430-4449
Email
drhongpi@unitedmd.com
First Name & Middle Initial & Last Name & Degree
John Hong
Facility Name
University of Southern California Medical Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
949-557-0251
Email
caroline.hwang@hoag.org
First Name & Middle Initial & Last Name & Degree
Caroline Hwang
Facility Name
Clinnova Research
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
949-354-5353
Email
abhanvadia.cr@gmail.com
First Name & Middle Initial & Last Name & Degree
Amit Bhanvadia
Facility Name
University of California at Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
888-717-4463
Ext
7144567358
Email
parekhn@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Nimisha Parekh
Facility Name
Kaiser Permanate of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
303-720-2685
Email
christopher.j.shepela@kp.org
First Name & Middle Initial & Last Name & Degree
Christopher Shepela
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
203-281-5161
Ext
2032814463
Email
pginsburg@gastrocenter.org
First Name & Middle Initial & Last Name & Degree
Philip Ginsburg
Facility Name
West Central Gastroenterology d/b/a Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
727-347-0005
Email
uchoudhry@gastrofl.com
First Name & Middle Initial & Last Name & Degree
Umesh Choudhry
Facility Name
Gastroenterology Associates of Pensacola, PA
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
850-436-4536
Email
fnewman@gastrohealth.com
First Name & Middle Initial & Last Name & Degree
Frederic Newman
Facility Name
West Central Gastroenterology d/b/a Gastro Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33626
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
727-347-0005
Email
aawad@gastrofl.com
First Name & Middle Initial & Last Name & Degree
Amir Awad
Facility Name
Emory Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
404-778-3184
Email
tdhere@emory.edu
First Name & Middle Initial & Last Name & Degree
Tanvi Dhere
Facility Name
Grand Teton Research Group, PLL
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
208-522-4000
Email
scott@gtrgi.org
First Name & Middle Initial & Last Name & Degree
Michael Richins
Facility Name
GI Alliance
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
847-439-1005
Email
mbernsen@illinoisgastro.com
First Name & Middle Initial & Last Name & Degree
Mitchell Bernsen
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
773-834-7414
Email
drubin@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
David Rubin
Facility Name
GI Alliance
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
847-244-2960
Ext
8472442960
Email
jrosenberg@illinoisgastro.com
First Name & Middle Initial & Last Name & Degree
Jonathan Rosenberg
Facility Name
Comprehensive Gastrointestinal Health
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
224-407-4400
Email
jnathanson@compgihealth.com
First Name & Middle Initial & Last Name & Degree
Jeffrey Nathanson
Facility Name
Rockford Gastroenterology Associates, Ltd.
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
815-397-7340
Ext
8154847930
Email
drpatel@rockfordgi.com
First Name & Middle Initial & Last Name & Degree
Sunil Patel
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
317-944-3332
Email
mofische@iu.edu
First Name & Middle Initial & Last Name & Degree
Monika Fischer
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
515-225-6050
Ext
5155643979
Email
bleman@hmrtrials.com
First Name & Middle Initial & Last Name & Degree
Bernard Leman
Facility Name
University Of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
319-384-6336
Email
steven-polyak@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Steven Polyak
Facility Name
University of Kansas Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
913-588-6158
Ext
9135886019
Email
faslinia@kumc.edu
First Name & Middle Initial & Last Name & Degree
Florence Hosseini-Aslinia
Facility Name
GI Alliance - Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
225-927-1190
Ext
7850
Email
jchapman@tddctx.com
First Name & Middle Initial & Last Name & Degree
Jonathon Chapman
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
318-631-9121
Email
haguilar@gis.md
First Name & Middle Initial & Last Name & Degree
Humberto Aguilar
Facility Name
University of Maryland School of Medicine.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
410-706-3387
Email
spatil@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Seema Patil
Facility Name
Gastro Center of Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
410-290-6677
Email
rrai@gastromaryland.com
First Name & Middle Initial & Last Name & Degree
Rudrajit Rai
Facility Name
Lahey Clinic Inc. - PARENT ACCOUNT
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
781-744-8740
Email
randall.pellish@lahey.org
First Name & Middle Initial & Last Name & Degree
Randall Pellish
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
508-754-1956
Ext
7744424098
Email
christopher.marshall@umassmemorial.org
First Name & Middle Initial & Last Name & Degree
Christopher Marshall
Facility Name
Digestive Health to Clinical Research Institute of Michigan (CRIM)
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
248-267-8485
Email
john.weber@pinnaclegipartners.com
First Name & Middle Initial & Last Name & Degree
John Weber
Facility Name
Gastroenterology Associates of Western Michigan, P.L.C.
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
616-328-5344
Email
acoates@gastro-assoc-wm.com
First Name & Middle Initial & Last Name & Degree
Allan Coates
Facility Name
BVL Clinical Research
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
800-407-9314
Email
c.bartalos@bvlresearch.com
First Name & Middle Initial & Last Name & Degree
Christopher Bartalos
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
505-272-6225
Email
spaleti@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Swati Paleti
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
212-434-6785
Email
aswaminath@northwell.edu
First Name & Middle Initial & Last Name & Degree
Arun Swaminath
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
336-713-7331
Email
pagreen@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Patrick Green
Facility Name
Clinical Inquest Center Ltd
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
937-429-2422
Email
daniel@cic-america.com
First Name & Middle Initial & Last Name & Degree
Daniel Whitmer
Facility Name
Dayton Gastroenterology, Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
937-320-5050
Email
ikramuddin@daytongastro.com
First Name & Middle Initial & Last Name & Degree
Ilyas Ikramuddin
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
440-205-1225
Email
kfriedenberg@thectnx.com
First Name & Middle Initial & Last Name & Degree
Keith Friedenberg
Facility Name
Digestive Disease Specialists, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
405-702-1246
Email
david.stokesberry@okddsi.net
First Name & Middle Initial & Last Name & Degree
David Stokesberry
Facility Name
The Oregon Clinic, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
503-963-2707
Email
pkiyasu@orclinic.com
First Name & Middle Initial & Last Name & Degree
Phillip Kiyasu
Facility Name
Susquehanna Research Group, LLC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
717-914-7770
Email
lsurace@gicare.com
First Name & Middle Initial & Last Name & Degree
Lindsey Surace
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
215-349-8527
Email
faten.aberra@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Faten Aberra
Facility Name
Allegheny Center for Digestive Health
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
412-578-5676
Email
sandra.elhachem@ahn.org
First Name & Middle Initial & Last Name & Degree
Sandra El-Hachem
Facility Name
University of Pittsburgh Medical Center Health System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
773-597-8533
Email
schwartzm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Marc Schwartz
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
724-550-4099
Email
fruthardtresearch@yahoo.com
First Name & Middle Initial & Last Name & Degree
Frederick Ruthardt
Facility Name
Palmetto Primary Care Physician Division of Gastroenterology
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
843-376-0670
Email
bvanleer1@gmail.com
First Name & Middle Initial & Last Name & Degree
Brett Van Leer-Greenberg
Facility Name
Rapid City Medical Center, LLC
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
605-721-8181
Email
gitex66@gmail.com
First Name & Middle Initial & Last Name & Degree
Blake Jones
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
615-343-4767
Ext
6153224643
Email
elizabeth.a.scoville@vumc.org
First Name & Middle Initial & Last Name & Degree
Elizabeth Scoville
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
512-495-5641
Ext
5124955690
Email
linda.feagins@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Linda Feagins
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
713-798-8220
Email
rshukla@bcm.edu
First Name & Middle Initial & Last Name & Degree
Richa Shukla
Facility Name
GI Alliance - Southlake
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
817-612-5575
Email
tim.ritter@gialliance.com
First Name & Middle Initial & Last Name & Degree
Timothy Ritter
Facility Name
Care Access Research LLC
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
801-614-5505
Email
drgonzales@careaccessresearch.com
First Name & Middle Initial & Last Name & Degree
Chad Gonzales
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
801-587-7678
Email
ann.flynn@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Ann Flynn
Facility Name
GCGA Physicians LLC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
703-698-8960
Email
kmirkin@novagi.com
First Name & Middle Initial & Last Name & Degree
Kenneth Mirkin
Facility Name
Gastroenterology Associates
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
434-455-8670
Email
l.clark@gastrocentralva.com
First Name & Middle Initial & Last Name & Degree
Larry Clark
Facility Name
Washington Gastroenterology
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
425-452-8547
Email
vmohan@washgi.com
First Name & Middle Initial & Last Name & Degree
Venkatachala Mohan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/605cd65feb9d7e001f5bc6a2
Description
To obtain more information on the study, click on this link.

Learn more about this trial

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

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