Trial Outcomes & Findings for Defining Predictors of RT Response to Vedolizumab in IBD (NCT NCT03142321)
NCT ID: NCT03142321
Last Updated: 2025-09-17
Results Overview
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.
COMPLETED
PHASE4
48 participants
24±2 weeks
2025-09-17
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
Week 14 Dose Escalation to Every 4 Weeks
|
2
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Defining Predictors of RT Response to Vedolizumab in IBD
Baseline characteristics by cohort
| Measure |
Vedolizumab 300 MG Injection [Entyvio]
n=48 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
33.95 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=93 Participants
|
|
Montreal Location
L1 - terminal ileum
|
8 participants
n=93 Participants
|
|
Montreal Location
L3 - ileocolonic
|
40 participants
n=93 Participants
|
|
Montreal Behavior
B1 non-stricturing, non-penetrating
|
22 Participants
n=93 Participants
|
|
Montreal Behavior
B1p non-stricturing, non-penetrating with perianal disease
|
3 Participants
n=93 Participants
|
|
Montreal Behavior
B2 stricturing
|
8 Participants
n=93 Participants
|
|
Montreal Behavior
B2p stricturing with perianal disease
|
1 Participants
n=93 Participants
|
|
Montreal Behavior
B3 penetrating
|
7 Participants
n=93 Participants
|
|
Montreal Behavior
B3p penetrating with perianal disease
|
7 Participants
n=93 Participants
|
|
Montreal Age Classification
1 - Age of diagnosis at 16 years or younger
|
6 Participants
n=93 Participants
|
|
Montreal Age Classification
2 - Age of diagnosis at 17-40 years
|
32 Participants
n=93 Participants
|
|
Montreal Age Classification
3 - Age of diagnosis at >40 years
|
10 Participants
n=93 Participants
|
|
BMI
|
28.10 kg/m^2
n=93 Participants
|
|
Upper GI Involvement
No
|
37 Participants
n=93 Participants
|
|
Upper GI Involvement
Yes
|
11 Participants
n=93 Participants
|
|
Perianal Involvement
No
|
37 Participants
n=93 Participants
|
|
Perianal Involvement
Perianal Involvement
|
11 Participants
n=93 Participants
|
|
Baseline Harvey Bradshaw Index Score
|
5 units on a scale
n=93 Participants
|
|
Baseline Crohn's Disease Activity Index Score
|
143.00 units on a scale
n=93 Participants
|
|
Baseline EQ-5D Base_Mobility
1 - No problem walking
|
36 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Mobility
2 - Slight problems walking
|
2 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Mobility
3 - Moderate problems walking
|
3 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Mobility
4 - Severe problems walking
|
0 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Mobility
5 - Unable to walk
|
0 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Mobility
NA
|
7 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Self-Care
1 - No problems washing or dressing
|
37 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Self-Care
2 - Slight problems washing or dressing
|
3 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Self-Care
3 - Moderate problems washing or dressing
|
1 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Self-Care
4 - Severe problems washing or dressing
|
0 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Self-Care
5 - Unable to wash or dress
|
0 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Self-Care
NA
|
7 Participants
n=93 Participants
|
|
Baselin eEQ-5D Base_Usual Activities
1 - No problems doing usual activities
|
26 Participants
n=93 Participants
|
|
Baselin eEQ-5D Base_Usual Activities
2 - Slight problems doing usual activities
|
7 Participants
n=93 Participants
|
|
Baselin eEQ-5D Base_Usual Activities
3 - Moderate problems doing usual activities
|
7 Participants
n=93 Participants
|
|
Baselin eEQ-5D Base_Usual Activities
4 - Severe problems doing usual activities
|
1 Participants
n=93 Participants
|
|
Baselin eEQ-5D Base_Usual Activities
5 - Unable to do usual activities
|
0 Participants
n=93 Participants
|
|
Baselin eEQ-5D Base_Usual Activities
NA
|
7 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Pain Discomfort
1 - No pain or discomfort
|
15 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Pain Discomfort
2 - Slight pain or discomfort
|
8 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Pain Discomfort
3 - Moderate pain or discomfort
|
10 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Pain Discomfort
4 - Severe pain or discomfort
|
6 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Pain Discomfort
5 - Extreme pain or discomfort
|
2 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Pain Discomfort
NA
|
7 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Anxiety
1 - Not anxious or depressed
|
22 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Anxiety
2 - Slightly anxious or depressed
|
6 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Anxiety
3 - Moderately anxious or depressed
|
6 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Anxiety
4 - Severely anxious or depressed
|
7 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Anxiety
5 - Extremely anxious or depressed
|
0 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Anxiety
NA
|
7 Participants
n=93 Participants
|
|
Baseline EQ-5D Base_Your Health Today, 0-100
|
80 units on a scale of 0-100
n=93 Participants
|
PRIMARY outcome
Timeframe: 24±2 weeksRadiological 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.
Outcome measures
| Measure |
Vedolizumab 300 MG Injection [Entyvio]
n=22 Participants
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
|
|---|---|
|
Radiological Response
Transmural Ulcer Healing
|
21 participants
|
|
Radiological Response
Transmural Remission
|
16 participants
|
PRIMARY outcome
Timeframe: 52±2 weeksRadiological 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.
Outcome measures
| Measure |
Vedolizumab 300 MG Injection [Entyvio]
n=12 Participants
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
|
|---|---|
|
Radiological Response
Transmural Ulcer Healing
|
12 participants
|
|
Radiological Response
Transmural Remission
|
9 participants
|
Adverse Events
Vedolizumab 300 MG Injection [Entyvio] Every 8 Weeks
Vedolizumab 300 MG Injection [Entyvio] Every 4 Weeks (Dose Escalation) After Week 14
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Parakkal Deepak
Washington University School of Medicine GI Division
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place