Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis (NCT NCT02790138)
NCT ID: NCT02790138
Last Updated: 2022-02-24
Results Overview
Clinically relevant remission is defined as modified Pouchitis Disease Activity Index (mPDAI) score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease.
COMPLETED
PHASE4
102 participants
Week 14
2022-02-24
Participant Flow
Participants took part in the study at 31 investigative sites in Canada, United States, Belgium, France, Germany, Italy, Netherlands, Spain, and United Kingdom from 12 October 2016 to 2 February 2021.
Participants with a diagnosis of chronic or recurrent pouchitis were enrolled in a 1:1 ratio to receive placebo IV or vedolizumab IV 300 mg.
Participant milestones
| Measure |
Placebo IV
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
30
|
32
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
Reasons for withdrawal
| Measure |
Placebo IV
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
|
Overall Study
Significant Protocol Deviation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Voluntary Withdrawal
|
8
|
9
|
|
Overall Study
Lack of Efficacy
|
6
|
7
|
|
Overall Study
Reason not Specified
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis
Baseline characteristics by cohort
| Measure |
Placebo IV
n=51 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=51 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 13.48 • n=93 Participants
|
40.8 years
STANDARD_DEVIATION 11.32 • n=4 Participants
|
41.9 years
STANDARD_DEVIATION 12.44 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Height
|
175.3 cm
STANDARD_DEVIATION 9.10 • n=93 Participants
|
172.4 cm
STANDARD_DEVIATION 10.79 • n=4 Participants
|
173.8 cm
STANDARD_DEVIATION 10.04 • n=27 Participants
|
|
Weight
|
79.60 kg
STANDARD_DEVIATION 19.115 • n=93 Participants
|
72.13 kg
STANDARD_DEVIATION 17.588 • n=4 Participants
|
75.87 kg
STANDARD_DEVIATION 18.658 • n=27 Participants
|
|
Body Mass Index (BMI)
|
25.74 kg/m^2
STANDARD_DEVIATION 5.125 • n=93 Participants
|
24.13 kg/m^2
STANDARD_DEVIATION 4.891 • n=4 Participants
|
24.93 kg/m^2
STANDARD_DEVIATION 5.049 • n=27 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, as randomized.
Clinically relevant remission is defined as modified Pouchitis Disease Activity Index (mPDAI) score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease.
Outcome measures
| Measure |
Placebo IV
n=51 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=51 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 14
|
9.8 percentage of participants
Interval 3.3 to 21.4
|
31.4 percentage of participants
Interval 19.1 to 45.9
|
SECONDARY outcome
Timeframe: Week 34Population: FAS included all randomized participants who received at least 1 dose of study medication, as randomized.
Clinically relevant remission is defined as mPDAI score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease.
Outcome measures
| Measure |
Placebo IV
n=51 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=51 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 34
|
17.6 percentage of participants
Interval 8.4 to 30.9
|
35.3 percentage of participants
Interval 22.4 to 49.9
|
SECONDARY outcome
Timeframe: Weeks 14 and 34Population: FAS included all randomized participants who received at least 1 dose of study medication, as randomized.
PDAI remission is PDAI score \<7 and a reduction of PDAI score by ≥3 points from Baseline. The 18-point PDAI score is calculated as a sum of three 6-point scales with total possible subscore of 0 (best) to 6 (worse) and possible total score of 0 (best) to 18 (worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations. Each item is scored on scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0(best) to 6(worst);3) Acute Histologic Inflammation:Polymorphic nuclear leukocyte infiltration(0=None to 3=Severe plus crypt abscess),Ulceration per low power field\[mean\](0=0% to 3=\>50%) where higher scores indicate more severe disease.
Outcome measures
| Measure |
Placebo IV
n=51 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=51 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Percentage of Participants Achieving Pouchitis Disease Activity Index (PDAI) Remission at Weeks 14 and 34
Week 14
|
9.8 percentage of participants
Interval 3.3 to 21.4
|
35.3 percentage of participants
Interval 22.4 to 49.9
|
|
Percentage of Participants Achieving Pouchitis Disease Activity Index (PDAI) Remission at Weeks 14 and 34
Week 34
|
17.6 percentage of participants
Interval 8.4 to 30.9
|
37.3 percentage of participants
Interval 24.1 to 51.9
|
SECONDARY outcome
Timeframe: Baseline up to Week 34Population: FAS included all randomized participants who received at least 1 dose of study medication, as randomized.
Time to remission-time in days from start of treatment to PDAI Remission(PDAI score \<7 and decrease in PDAI score ≥3 points from Baseline).18-point PDAI score-calculated as sum of 3, 6-point scales with total possible subscore of 0(best) to 6(worse) and possible total score of 0(best)to18(worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations.Each item is scored on scale of 0=not present to 1=present summed up to an endoscopic subscore=0(best) to 6(worst);3)Acute Histologic Inflammation:Polymorphic nuclear leukocyte infiltration(0=None to 3=Severe plus crypt abscess),Ulceration per low power field\[mean\](0=0% to 3=\>50%),higher scores=more severe disease.
Outcome measures
| Measure |
Placebo IV
n=51 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=50 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Time to PDAI Remission
|
NA days
Median and 95% Confidence Interval (CI) was not estimated due to the low number of participants with events.
|
239.0 days
Interval 101.0 to
Upper limit of 95% CI was not estimated due do the low number of participants with events.
|
SECONDARY outcome
Timeframe: Weeks 14 and 34Population: FAS included all randomized participants who received at least 1 dose of study medication, as randomized.
Partial mPDAI response is defined as a reduction in mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst:1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease. Last observation carried forward (LOCF) method was used for analyses.
Outcome measures
| Measure |
Placebo IV
n=51 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=51 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Percentage of Participants Achieving a Partial mPDAI Response at Weeks 14 and 34
Week 14
|
33.3 percentage of participants
Interval 20.8 to 47.9
|
62.7 percentage of participants
Interval 48.1 to 75.9
|
|
Percentage of Participants Achieving a Partial mPDAI Response at Weeks 14 and 34
Week 34
|
29.4 percentage of participants
Interval 17.5 to 43.8
|
51.0 percentage of participants
Interval 36.6 to 65.2
|
SECONDARY outcome
Timeframe: Baseline up to Weeks 14 and 34Population: FAS included all randomized participants who received at least 1 dose of study medication, as randomized.
The PDAI Endoscopic Inflammation subscore is a sum of scores from findings for Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates, and Ulcerations, each scored on 0=not present to 1=present scale summed up to a subscore ranging from 0 (best) to 6 (worse) where higher scores = more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.
Outcome measures
| Measure |
Placebo IV
n=51 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=51 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Change From Baseline in PDAI Endoscopic Inflammation Subscore at Weeks 14 and 34
Baseline
|
4.5 score on a scale
Standard Deviation 1.36
|
4.6 score on a scale
Standard Deviation 1.15
|
|
Change From Baseline in PDAI Endoscopic Inflammation Subscore at Weeks 14 and 34
Change from Baseline at Week 14
|
-0.2 score on a scale
Standard Deviation 1.36
|
-1.1 score on a scale
Standard Deviation 1.59
|
|
Change From Baseline in PDAI Endoscopic Inflammation Subscore at Weeks 14 and 34
Change from Baseline at Week 34
|
-0.6 score on a scale
Standard Deviation 1.86
|
-1.2 score on a scale
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: Baseline up to Weeks 14 and 34Population: FAS included all randomized participants who received at least 1 dose of study medication, as randomized. Overall number analyzed are the number of participants with data evaluable for analyses.
The PDAI Acute Histologic Inflammation subscore is a sum score from findings for Polymorphic nuclear leukocyte infiltration (0=None to 3=Severe plus crypt abscess), and Ulceration per low power field \[mean\] (0=0% to 3= \>50%) summed up to a subscore ranging from 0 (best) to 6 (worse) where higher scores = more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.
Outcome measures
| Measure |
Placebo IV
n=51 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=50 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Change From Baseline in PDAI Acute Histologic Inflammation Subscore at Weeks 14 and 34
Baseline
|
2.6 score on a scale
Standard Deviation 1.39
|
2.5 score on a scale
Standard Deviation 1.42
|
|
Change From Baseline in PDAI Acute Histologic Inflammation Subscore at Weeks 14 and 34
Change from Baseline at Week 14
|
-0.1 score on a scale
Standard Deviation 1.33
|
-0.4 score on a scale
Standard Deviation 1.98
|
|
Change From Baseline in PDAI Acute Histologic Inflammation Subscore at Weeks 14 and 34
Change from Baseline at Week 34
|
-0.2 score on a scale
Standard Deviation 1.52
|
-0.2 score on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Baseline up to Weeks 14 and 34Population: FAS included all randomized participants who received at least 1 dose of study medication, as randomized. Overall number analyzed are the number of participants with data evaluable for analyses.
The 18-point PDAI score is calculated as a sum of three 6-point scales with total possible subscore of 0 (best) to 6 (worse) and possible total score of 0 (best) to 18 (worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations. Each item is scored on scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0(best) to 6(worst);3)Acute Histologic Inflammation:Polymorphic nuclear leukocyte infiltration(0=None to 3=Severe plus crypt abscess),Ulceration per low power field\[mean\](0=0% to 3=\>50%) where higher scores=more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.
Outcome measures
| Measure |
Placebo IV
n=51 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=50 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Change From Baseline in Total PDAI Score at Weeks 14 and 34
Baseline
|
10.5 score on a scale
Standard Deviation 2.48
|
10.5 score on a scale
Standard Deviation 2.20
|
|
Change From Baseline in Total PDAI Score at Weeks 14 and 34
Change from Baseline at Week 14
|
-1.3 score on a scale
Standard Deviation 2.68
|
-2.7 score on a scale
Standard Deviation 3.86
|
|
Change From Baseline in Total PDAI Score at Weeks 14 and 34
Change from Baseline at Week 34
|
-1.6 score on a scale
Standard Deviation 3.41
|
-2.9 score on a scale
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: Baseline up to Weeks 14, 22, and 34Population: FAS included all randomized participants who received at least 1 dose of study medication, as randomized. Overall number analyzed are the number of participants with data evaluable for analyses.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A negative change from Baseline indicates worsening. LOCF method was used for analyses.
Outcome measures
| Measure |
Placebo IV
n=50 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=51 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 14, 22, and 34
Baseline
|
131.5 score on a scale
Standard Deviation 30.78
|
137.9 score on a scale
Standard Deviation 33.53
|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 14, 22, and 34
Change from Baseline at Week 14
|
14.6 score on a scale
Standard Deviation 26.67
|
18.3 score on a scale
Standard Deviation 29.20
|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 14, 22, and 34
Change from Baseline at Week 22
|
16.0 score on a scale
Standard Deviation 29.12
|
21.3 score on a scale
Standard Deviation 31.28
|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 14, 22, and 34
Change from Baseline at Week 34
|
10.4 score on a scale
Standard Deviation 25.98
|
24.4 score on a scale
Standard Deviation 34.21
|
SECONDARY outcome
Timeframe: Baseline up to Weeks 14, 22, and 34Population: FAS included all randomized participants who received at least 1 dose of study medication, as randomized. Overall number analyzed are the number of participants with data evaluable for analyses.
The CGQL (Fazio score) is a quality-of-life indicator specifically for participants with ileal pouch-anal anastomosis. Participants rate 3 items (current quality of life, current quality of health, and current energy level), each on a scale of 0 to 10 (0=worst; 10=best). The scores are added, and the final CGQL utility score is obtained by dividing this result by 30. The total score ranges from 0 (worst) to 1 (best) where lower scores indicate less quality of life. A negative change from Baseline indicates worsening. LOCF method was used for analyses.
Outcome measures
| Measure |
Placebo IV
n=49 Participants
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=50 Participants
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Change From Baseline in Cleveland Global Quality of Life (CGQL) at Weeks 14, 22, and 34
Baseline
|
0.522 score on a scale
Standard Deviation 0.1953
|
0.556 score on a scale
Standard Deviation 0.1626
|
|
Change From Baseline in Cleveland Global Quality of Life (CGQL) at Weeks 14, 22, and 34
Change from Baseline at Week 14
|
0.051 score on a scale
Standard Deviation 0.1518
|
0.088 score on a scale
Standard Deviation 0.1715
|
|
Change From Baseline in Cleveland Global Quality of Life (CGQL) at Weeks 14, 22, and 34
Change from Baseline at Week 22
|
0.073 score on a scale
Standard Deviation 0.1491
|
0.093 score on a scale
Standard Deviation 0.1648
|
|
Change From Baseline in Cleveland Global Quality of Life (CGQL) at Weeks 14, 22, and 34
Change from Baseline at Week 34
|
0.056 score on a scale
Standard Deviation 0.1544
|
0.083 score on a scale
Standard Deviation 0.1831
|
Adverse Events
Placebo IV
Vedolizumab IV 300 mg
Serious adverse events
| Measure |
Placebo IV
n=51 participants at risk
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=51 participants at risk
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Pouchitis
|
2.0%
1/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
2/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.0%
1/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
1/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.0%
1/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo IV
n=51 participants at risk
Vedolizumab placebo-matching IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
Vedolizumab IV 300 mg
n=51 participants at risk
Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.
|
|---|---|---|
|
Gastrointestinal disorders
Pouchitis
|
39.2%
20/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
45.1%
23/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.6%
9/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.7%
7/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
19.6%
10/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
6/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.8%
6/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
9.8%
5/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.8%
5/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
5/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
2/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
2/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.8%
4/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
3.9%
2/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.8%
4/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
2.0%
1/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.8%
4/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
5.9%
3/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
1/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
3/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.8%
5/51 • From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER