Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
CDPATHâ„¢ 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 CDPATHâ„¢ 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.
The tool being tested in this study is called CDPATHâ„¢. CDPATHâ„¢ 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 CDPATHâ„¢.
The study will enroll approximately 200 patients. Participants and health care providers (HCPs) will be surveyed to understand their satisfaction with the CDPATHâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDPATHâ„¢ | Experimental | Participants with CD will be using CDPATHâ„¢ 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 CDPATHâ„¢ analysis. 1 additional sample will be collected for future potential biomarker analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDPATHâ„¢ | Other | Crohn's disease risk prediction tool. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Real-world Practice in Each Risk Category at Baseline Based on the CDPATHâ„¢ Tool Results | The risk profile of an individual participant with CD is the output of the CDPATHâ„¢ tool. Categories for CD includes low, medium, high risk of developing a CD complication within 3 years. | Baseline (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Specific Treatment Path and Choice Based on CDPATHâ„¢ 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Research, PLLC | Phoenix | Arizona | 85032 | United States | ||
| VA Loma Linda Healthcare System |
Not provided
| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
Not provided
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.
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood Draw | Other | Three blood samples will be drawn. |
|
| 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 |
| 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 |
| 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 |
| Patient-Reported Satisfaction and Experience Score with the CDPATHâ„¢ Tool | Participant's satisfaction and experience with the CDPATHâ„¢ 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 |
| 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 |
| 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 |
| Change from First Assessment in Health Care Provider (HCP)-reported Assessment of the Feasibility and Usability of the CDPATHâ„¢ Tool | HCP-reported CDPATHâ„¢ 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) |
| Loma Linda |
| California |
| 92357 |
| United States |
| United Medical Doctors | Murrieta | California | 92563 | United States |
| University of Southern California Medical Center | Newport Beach | California | 92663 | United States |
| Clinnova Research Solutions | Orange | California | 92868 | United States |
| University of California at Irvine Medical Center | Orange | California | 92868 | United States |
| Kaiser Permanate of Colorado | Aurora | Colorado | 80014 | United States |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33762 | United States |
| Gastroenterology Associates of Pensacola, PA | Pensacola | Florida | 32503 | United States |
| Grand Teton Research Group, PLL | Idaho Falls | Idaho | 83404 | United States |
| GI Alliance | Arlington Heights | Illinois | 60005 | United States |
| GI Alliance | Gurnee | Illinois | 60031 | United States |
| Comprehensive Gastrointestinal Health | Northbrook | Illinois | 60062 | United States |
| Rockford Gastroenterology Associates, Ltd. | Rockford | Illinois | 61107 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242-1009 | United States |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | United States |
| GI Alliance - Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | United States |
| Gastro Center of Maryland | Columbia | Maryland | 21045 | United States |
| Lahey Clinic Inc. - PARENT ACCOUNT | Burlington | Massachusetts | 01805 | United States |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131-0001 | United States |
| Lenox Hill Hospital | New York | New York | 10075-1850 | United States |
| Clinical Inquest Center Ltd | Beavercreek | Ohio | 45431 | United States |
| Dayton Gastroenterology, Inc | Dayton | Ohio | 45415 | United States |
| The Oregon Clinic, P.C. | Portland | Oregon | 97220-9442 | United States |
| Susquehanna Research Group, LLC | Camp Hill | Pennsylvania | 17011 | United States |
| Allegheny Center for Digestive Health | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center Health System | Pittsburgh | Pennsylvania | 15213 | United States |
| Frontier Clinical Research, LLC | Uniontown | Pennsylvania | 15401 | United States |
| Palmetto Primary Care Physician Division of Gastroenterology | Summerville | South Carolina | 29486 | United States |
| Rapid City Medical Center, LLC | Rapid City | South Dakota | 57701 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37204 | United States |
| The University of Texas at Austin | Austin | Texas | 78712 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| GI Alliance - Southlake | Southlake | Texas | 76092 | United States |
| Care Access Research Berkley | Ogden | Utah | 84403 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| GCGA Physicians LLC | Fairfax | Virginia | 22031 | United States |
| Gastroenterology Associates | Lynchburg | Virginia | 24502 | United States |
| GI Alliance | Bellevue | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided