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The overall goal of the study is to develop data that can convincingly guide clinicians on the use and efficacy of vedolizumab in patients with small bowel CD. There is an unmet need to identify response to vedolizumab in small bowel CD using objective endpoints. Current data suggest that MR enterography may meet this unmet need. There is an additional unmet need to develop predictive models incorporating both clinical and baseline radiological and endoscopic variables with higher discriminatory performance in identifying longer term clinical remission with vedolizumab. Finally, this proposal is strengthened by the exploratory studies which may identify new proteomic biomarkers that correlate with longer term radiological response with vedolizumab reflecting its latency of response. If successful, these serum biomarkers may guide a personalized approach to the treatment of small bowel CD with vedolizumab, allowing early identification of PNR, monitoring disease activity and the pharmacodynamics of vedolizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vedolizumab 300 MG Injection [Entyvio] | Experimental | Vedolizumab will be initiated at 300 mg intravenous (IV) dosing at 0, 2 and 6 weeks followed by the 1st maintenance with 300 mg IV at week 14. Patients who have not achieved clinical response at week 14 will be eligible to undergo dose escalation to 4 weekly dosing of vedolizumab depending on the judgement of the treating gastroenterologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab 300 MG Injection [Entyvio] | Drug | Vedolizumab Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiological Response | Radiological Transmural Response will be defined per-lesion and per-patient. Per-lesion TR will be defined as a decrease in the length of inflamed small bowel lesion from baseline or improvement in any imaging findings associated with severe mural inflammation, i.e., restricted diffusion, mural thickness, intramural T2 hyperintensity, peri-enteric T2 signal, and luminal ulcerations, without development of a new penetrating or stricturing complication. Worsened lesions will be fined as those with an increased score of any imaging parameter associated with severe mural inflammation. Unchanged lesions will be defined as those with unchanged (without worsening or improving) inflammatory parameters associated with severe mural inflammation. Patients will be then classified for TR as responders if all individual lesions improved and non-responders if any of the lesions worsened, a new lesion developed at the 4 month MRE and all other scenarios not meeting definition of response. | 24±2 weeks |
| Radiological Response | Radiological Transmural Response will be defined per-lesion and per-patient. Per-lesion TR will be defined as a decrease in the length of inflamed small bowel lesion from baseline or improvement in any imaging findings associated with severe mural inflammation, i.e., restricted diffusion, mural thickness, intramural T2 hyperintensity, peri-enteric T2 signal, and luminal ulcerations, without development of a new penetrating or stricturing complication. Worsened lesions will be fined as those with an increased score of any imaging parameter associated with severe mural inflammation. Unchanged lesions will be defined as those with unchanged (without worsening or improving) inflammatory parameters associated with severe mural inflammation. Patients will be then classified for TR as responders if all individual lesions improved and non-responders if any of the lesions worsened, a new lesion developed at the 4 month MRE and all other scenarios not meeting definition of response. | 52±2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parakkal Deepak, MBBS, MS | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27166131 | Background | Deepak P, Fletcher JG, Fidler JL, Barlow JM, Sheedy SP, Kolbe AB, Harmsen WS, Loftus EV, Hansel SL, Becker BD, Bruining DH. Radiological Response Is Associated With Better Long-Term Outcomes and Is a Potential Treatment Target in Patients With Small Bowel Crohn's Disease. Am J Gastroenterol. 2016 Jul;111(7):997-1006. doi: 10.1038/ajg.2016.177. Epub 2016 May 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vedolizumab 300 MG Injection [Entyvio] | Vedolizumab will be initiated at 300 mg intravenous (IV) dosing at 0, 2 and 6 weeks followed by the 1st maintenance with 300 mg IV at week 14. Patients who have not achieved clinical response at week 14 will be eligible to undergo dose escalation to 4 weekly dosing of vedolizumab depending on the judgement of the treating gastroenterologist. Vedolizumab 300 MG Injection [Entyvio]: Vedolizumab Injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vedolizumab 300 MG Injection [Entyvio] | Vedolizumab will be initiated at 300 mg intravenous (IV) dosing at 0, 2 and 6 weeks followed by the 1st maintenance with 300 mg IV at week 14. Patients who have not achieved clinical response at week 14 will be eligible to undergo dose escalation to 4 weekly dosing of vedolizumab depending on the judgement of the treating gastroenterologist. Vedolizumab 300 MG Injection [Entyvio]: Vedolizumab Injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Radiological Response | Radiological Transmural Response will be defined per-lesion and per-patient. Per-lesion TR will be defined as a decrease in the length of inflamed small bowel lesion from baseline or improvement in any imaging findings associated with severe mural inflammation, i.e., restricted diffusion, mural thickness, intramural T2 hyperintensity, peri-enteric T2 signal, and luminal ulcerations, without development of a new penetrating or stricturing complication. Worsened lesions will be fined as those with an increased score of any imaging parameter associated with severe mural inflammation. Unchanged lesions will be defined as those with unchanged (without worsening or improving) inflammatory parameters associated with severe mural inflammation. Patients will be then classified for TR as responders if all individual lesions improved and non-responders if any of the lesions worsened, a new lesion developed at the 4 month MRE and all other scenarios not meeting definition of response. | Posted | Number | participants | 24±2 weeks |
|
Over the course of the participants time in the study, which was 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vedolizumab 300 MG Injection [Entyvio] Every 8 Weeks | Vedolizumab will be initiated at 300 mg intravenous (IV) dosing at 0, 2 and 6 weeks followed by the 1st maintenance with 300 mg IV at week 14. Patients who have not achieved clinical response at week 14 will be eligible to undergo dose escalation to 4 weekly dosing of vedolizumab depending on the judgement of the treating gastroenterologist. Vedolizumab 300 MG Injection [Entyvio]: Vedolizumab Injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Parakkal Deepak | Washington University School of Medicine GI Division | 3143623201 | nixd@wustl.edu |
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| 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 | Nov 8, 2024 | Aug 21, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C543529 | vedolizumab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Montreal Location | Montreal location classification for were disease is present | Number | participants |
|
| Montreal Behavior | Count of Participants | Participants |
|
| Montreal Age Classification | Count of Participants | Participants |
|
| BMI | Body mass index (BMI) is a medical screening tool that measures the ratio of your height to your weight to estimate the amount of body fat you have. Healthcare providers calculate BMI by using weight in kilograms (kg) divided by the square of height in meters (m2). | Median | Inter-Quartile Range | kg/m^2 |
|
| Upper GI Involvement | Count of Participants | Participants |
|
| Perianal Involvement | Count of Participants | Participants |
|
| Baseline Harvey Bradshaw Index Score | The Harvey-Bradshaw Index (HBI) allow physicians to quickly categorize the severity of CD and detect remission. The total HBI score ranges from a minimum of "0" to "no theoretical maximum score." The theoretical maximum score is dependent on the number of liquid stools reported by the patient per day. A reported total HBI score of less than 5 indicates remission, 5-7 suggests mild severity, 8-16 denotes moderate severity, and greater than or equal to 16 demarks severe disease. | Mean | Inter-Quartile Range | units on a scale |
|
| Baseline Crohn's Disease Activity Index Score | The CDAI measures the severity of active disease using 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). The CDAI score is calculated by summing weighted scores for each item. CDAI scores range from minimum of 0 to maximum of 600, with higher scores indicating greater disease activity. Clinical remission is defined by a CDAI score of ≤ 150 points. | Mean | Inter-Quartile Range | units on a scale |
|
| Baseline EQ-5D Base_Mobility | The descriptive system comprises the same 5 dimensions as the EQ5D-3L (mobility, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The reported values are the breakdown of how many participants responded to each level at Baseline. | Count of Participants | Participants |
|
| Baseline EQ-5D Base_Self-Care | The descriptive system comprises the same 5 dimensions as the EQ5D-3L (mobility, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A total score is derived based on responses. The reported values are the breakdown of how many participants responded to each level at Baseline. | Count of Participants | Participants |
|
| Baselin eEQ-5D Base_Usual Activities | The descriptive system comprises the same 5 dimensions as the EQ5D-3L (mobility, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The reported values are the breakdown of how many participants responded to each level at Baseline. | Count of Participants | Participants |
|
| Baseline EQ-5D Base_Pain Discomfort | The descriptive system comprises the same 5 dimensions as the EQ5D-3L (mobility, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The reported values are the breakdown of how many participants responded to each level at Baseline. | Count of Participants | Participants |
|
| Baseline EQ-5D Base_Anxiety | The descriptive system comprises the same 5 dimensions as the EQ5D-3L (mobility, self care, usual activities, pain/discomfort, anxiety/depression). However, each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The reported values are the breakdown of how many participants responded to each level at Baseline. | Count of Participants | Participants |
|
| Baseline EQ-5D Base_Your Health Today, 0-100 | The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The EQ VAS has a scale of 0-100. This information can be used as a quantitative measure of health as judged by the individual respondents. The reported value is the median EQ-VAS score reported by all patients with a range of 65-90. | Median | Inter-Quartile Range | units on a scale of 0-100 |
|
| Vedolizumab 300 MG Injection [Entyvio] |
Vedolizumab will be initiated at 300 mg intravenous (IV) dosing at 0, 2 and 6 weeks followed by the 1st maintenance with 300 mg IV at week 14. Patients who have not achieved clinical response at week 14 will be eligible to undergo dose escalation to 4 weekly dosing of vedolizumab depending on the judgement of the treating gastroenterologist. Vedolizumab 300 MG Injection [Entyvio]: Vedolizumab Injection |
|
|
| Primary | Radiological Response | Radiological Transmural Response will be defined per-lesion and per-patient. Per-lesion TR will be defined as a decrease in the length of inflamed small bowel lesion from baseline or improvement in any imaging findings associated with severe mural inflammation, i.e., restricted diffusion, mural thickness, intramural T2 hyperintensity, peri-enteric T2 signal, and luminal ulcerations, without development of a new penetrating or stricturing complication. Worsened lesions will be fined as those with an increased score of any imaging parameter associated with severe mural inflammation. Unchanged lesions will be defined as those with unchanged (without worsening or improving) inflammatory parameters associated with severe mural inflammation. Patients will be then classified for TR as responders if all individual lesions improved and non-responders if any of the lesions worsened, a new lesion developed at the 4 month MRE and all other scenarios not meeting definition of response. | Posted | Number | participants | 52±2 weeks |
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| 0 |
| 46 |
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| 46 |
| EG001 | Vedolizumab 300 MG Injection [Entyvio] Every 4 Weeks (Dose Escalation) After Week 14 | Vedolizumab will be initiated at 300 mg intravenous (IV) dosing at 0, 2 and 6 weeks followed by the 1st maintenance with 300 mg IV at week 14. Patients who have not achieved clinical response at week 14 will be eligible to undergo dose escalation to 4 weekly dosing of vedolizumab depending on the judgement of the treating gastroenterologist. Vedolizumab 300 MG Injection [Entyvio]: Vedolizumab Injection | 0 | 2 | 0 | 2 | 0 | 2 |
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| D007410 | Intestinal Diseases |