The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). Vedolizumab is commercially available in Japan for 8-weekly treatment but not for 4-weekly treatment. The study doctors will also monitor side effects from the study treatment. This study will take place in Japan. At the first visit, the study doctor will check if each person can take part. For those who can take part, participants will receive vedolizumab intravenously once every 4 weeks. After 3 infusions of vedolizumab (which will be 12 weeks of treatment), the study doctor will assess if symptoms of the participants have improved. Participants who do not have improved symptoms after 12 weeks of treatment with vedolizumab will stop this treatment. Then, they will visit the study clinic 16 weeks after their last infusion of vedolizumab for a final check-up. Participants who have improved symptoms after 12 weeks of treatment with vedolizumab will continue to receive vedolizumab every 4 weeks. Then, after their last infusion of vedolizumab, the participants will visit the study clinic 16 weeks later for a final check-up. Finally, the study clinic will make a phone call to each participant 6 months after their last infusion to check if they have any health problems.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Vedolizumab 300 mg, IV infusion
Ieda Hospital
Toyota, Aichi-ken, Japan
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Tsujinaka Hospital
Kashiwa, Chiba, Japan
Toho University Sakura Medical Center
Sakura, Chiba, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Sapporo Kosei General Hospital
Sapporo, Hokkaido, Japan
Hyogo College of Medicine Hospital
Nishinomiya, Hyōgo, Japan
Ofuna Chuo Hospital
Kamakura, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
...and 10 more locations
UC Cohort: Percentage of Participants With Clinical Response at Week 12 Based on Modified Mayo Score
Clinical response was defined as a reduction of greater than or equal to (\>=) 2 points and \>=25 percent (%) in modified mayo score, and a decrease of \>=1 point in rectal bleeding sub-score or rectal bleeding sub-score of less than or equal to (\<=) 1 from baseline (Week 0). Mayo score was an instrument designed to measure disease activity of UC. Modified mayo score consisted of 3 sub-scores: stool frequency, rectal bleeding, and mayo endoscopic sub-score (findings on endoscopy), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9. Here, a higher score indicated more severe disease.
Time frame: At Week 12
CD Cohort: Percentage of Participants With Clinical Response at Week 12
Clinical response was defined as a reduction of \>=70 points in Crohn's Disease Activity Index (CDAI) score from baseline (Week 0). A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicated greater disease activity.
Time frame: At Week 12
UC Cohort: Percentage of Participants With Clinical Remission at Week 12 Based on Modified Mayo Score
Clinical remission was defined as a modified Mayo score of less than or equal to (\<=) 2, and no individual sub-score greater than (\>) 1. Mayo score was an instrument designed to measure disease activity of UC. Modified Mayo score consisted of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic sub-score (findings on endoscopy), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score ranged of 0 to 9. Here, a higher score indicated a more severe disease.
Time frame: At Week 12
UC Cohort: Percentage of Participants With Mucosal Healing at Week 12
Mucosal healing was defined as a Mayo endoscopic sub-score of \<=1, in participants with baseline Mayo endoscopic sub-score of \>=2. Mayo score consisted of 4 sub-scores: stool frequency, rectal bleeding, mayo endoscopic sub-score (findings on endoscopy) and physician's global assessment, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score ranged of 0 to 12. Here, a higher score indicated a more severe disease.
Time frame: At Week 12
UC Cohort: Percentage of Participants With Corticosteroid-Free Remission Based on Partial Mayo Score
Corticosteroid-free remission was defined as participants using oral corticosteroids at baseline (Week 0) who have discontinued oral corticosteroids and were in clinical remission based on partial Mayo score at Week 52. Clinical remission based on partial Mayo score was defined as a partial Mayo score of =\<2, and no individual sub-score \>1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and physician's global assessment, each graded from 0 to 3 with higher scores indicated more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicated more severe disease.
Time frame: At Week 52
CD Cohort: Percentage of Participants With Clinical Remission at Week 12
Clinical remission was defined as a CDAI score of \<=150. A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicating greater disease activity.
Time frame: At Week 12
CD Cohort: Percentage of Participants With Enhanced Clinical Response at Week 12
Enhanced clinical response was defined as a reduction of \>=100 points in CDAI score from baseline (Week 0). A CDAI was a multi-item instrument that measured severity of active Crohn's Disease monitored over 7 days included participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI total score was equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores ranged approximately from 0 to 600, higher scores indicating greater disease activity.
Time frame: At Week 12
CD Cohort: Percentage of Participants With Corticosteroid-Free Remission
Corticosteroid-free remission was defined as participants using oral corticosteroids at baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52.
Time frame: At Week 52
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