Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PaCR-2017C2-8172-IC | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute (PCORI) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Crohn's and Colitis Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor necrosis factor (TNF) medications, using data from two existing cohorts.
This study is a secondary analysis using data from participants in the IBD Partners and SPARC-IBD cohorts. Data received from IBD Partners consists of patient-reported outcomes gathered via online surveys (baseline and 6-month follow-ups). Data received from SPARC-IBD consists of patient-reported outcomes gathered via surveys (baseline and follow-ups) as well as data from clinical records.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn's Disease (Vedolizumab) | Participants with Crohn's disease (CD) who reported taking vedolizumab. | ||
| Crohn's Disease (Ustekinumab) | Participants with Crohn's disease (CD) who reported taking ustekinumab. | ||
| Ulcerative Colitis (Vedolizumab) | Participants with Ulcerative colitis (UC) who reported taking vedolizumab. | ||
| Ulcerative Colitis (Tofacitinib) | Participants with Ulcerative colitis (UC) who reported taking tofacitinib. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Measures of Pain Interference | NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health). | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
| PROMIS Measures of Fatigue | NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Fatigue. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more fatigue (poorer health). | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Index Medication Persistence | Medication persistence was defined as continuing index medication. | 4-10 months after medication initiation |
| Number of Participants Using Corticosteroids at Follow-Up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Population: participants in IBD Partners or SPARC cohort.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Kappelman, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crohn's & Colitis Foundation | New York | New York | 10017 | United States | ||
| University of North Carolina |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Crohn's Disease (Vedolizumab) | Participants with Crohn's disease (CD) who reported taking vedolizumab. |
| FG001 | Crohn's Disease (Ustekinumab) | Participants with Crohn's disease (CD) who reported taking ustekinumab. |
| FG002 | Ulcerative Colitis (Vedolizumab) | Participants with Ulcerative colitis (UC) who reported taking vedolizumab. |
| FG003 | Ulcerative Colitis (Tofacitinib) | Participants with Ulcerative colitis (UC) who reported taking tofacitinib. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Crohn's Disease (Vedolizumab) | Participants with Crohn's disease (CD) who reported taking vedolizumab. |
| BG001 | Crohn's Disease (Ustekinumab) | Participants with Crohn's disease (CD) who reported taking ustekinumab. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PROMIS Measures of Pain Interference | NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health). | Posted | Mean | Standard Deviation | T-score | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
|
Adverse Events were not collected.
This was an observational study and not designed to assess adverse events; therefore, safety reporting was not applicable for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crohn's Disease (Vedolizumab) | Participants with Crohn's disease (CD) who reported taking vedolizumab. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kappelman, MD, MPH | University of North Carolina at Chapel Hill | 919-843-5908 | michael_kappelman@med.unc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2019 | Feb 17, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants who reported using corticosteroids.
| 4-10 months after medication initiation |
| Short Crohn's Disease Activity Index (sCDAI) | Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patients' symptoms using only a questionnaire, which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, stool frequency, and general well-being reported as a total score. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI with scores ranging from 0 to 600, such that scores,<150 define remission, 150 to 219 mild activity, 220 to 450 moderate activity, and greater than 450 severe activity. | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
| Mayo Clinic Score | The Mayo Clinic Score (MCS) asks 2 questions about (1) stool frequency and (2) rectal bleeding with an overall score range (0-6). Higher scores reflect more disease symptomatology. | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
| PROMIS Social Satisfaction Score | NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of social satisfaction. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score for social satisfaction indicates better health. | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
| Chapel Hill |
| North Carolina |
| 27599-7555 |
| United States |
| BG002 | Ulcerative Colitis (Vedolizumab) | Participants with Ulcerative colitis (UC) who reported taking vedolizumab. |
| BG003 | Ulcerative Colitis (Tofacitinib) | Participants with Ulcerative colitis (UC) who reported taking tofacitinib. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG002 | Ulcerative Colitis (Vedolizumab) | Participants with Ulcerative colitis (UC) who reported taking vedolizumab. |
| OG003 | Ulcerative Colitis (Tofacitinib) | Participants with Ulcerative colitis (UC) who reported taking tofacitinib. |
|
|
|
| Primary | PROMIS Measures of Fatigue | NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Fatigue. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more fatigue (poorer health). | Posted | Mean | Standard Deviation | T-score | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
|
|
|
|
| Secondary | Number of Participants With Index Medication Persistence | Medication persistence was defined as continuing index medication. | Posted | Count of Participants | Participants | 4-10 months after medication initiation |
|
|
|
|
| Secondary | Number of Participants Using Corticosteroids at Follow-Up | Participants who reported using corticosteroids. | All available data are reported. | Posted | Count of Participants | Participants | 4-10 months after medication initiation |
|
|
|
|
| Secondary | Short Crohn's Disease Activity Index (sCDAI) | Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patients' symptoms using only a questionnaire, which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, stool frequency, and general well-being reported as a total score. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI with scores ranging from 0 to 600, such that scores,<150 define remission, 150 to 219 mild activity, 220 to 450 moderate activity, and greater than 450 severe activity. | This outcome applies only to those participants who have Crohn's disease. | Posted | Mean | Standard Deviation | score on a scale | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
|
|
|
|
| Secondary | Mayo Clinic Score | The Mayo Clinic Score (MCS) asks 2 questions about (1) stool frequency and (2) rectal bleeding with an overall score range (0-6). Higher scores reflect more disease symptomatology. | This outcome applies only to those participants who have ulcerative colitis. All available data are reported. | Posted | Mean | Standard Deviation | score on a scale | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
|
|
|
|
| Secondary | PROMIS Social Satisfaction Score | NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of social satisfaction. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score for social satisfaction indicates better health. | Posted | Mean | Standard Deviation | T-score | Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Crohn's Disease (Ustekinumab) | Participants with Crohn's disease (CD) who reported taking ustekinumab. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Ulcerative Colitis (Vedolizumab) | Participants with Ulcerative colitis (UC) who reported taking vedolizumab. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Ulcerative Colitis (Tofacitinib) | Participants with Ulcerative colitis (UC) who reported taking tofacitinib. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| Superiority |
| Superiority |
| Superiority |
| Superiority |