Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]
- Registration Number
- NCT03824561
- Lead Sponsor
- Takeda
- Brief Summary
The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC) patients in the routine clinical setting.
- Detailed Description
The drug being tested in this survey is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have UC.
This survey is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical setting. The planned number of observed patients will be approximately 1,000.
This multi-center observational trial will be conducted in Japan.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1096
- Have moderate or severe active UC
- Have inadequate response to existing therapies
Patients with any contraindication for vedolizumab
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vedolizumab 300 mg Vedolizumab Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care.
- Primary Outcome Measures
Name Time Method Number of Participants who have One or More Adverse Events Up to Week 54 Adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants who have One or More Adverse Drug Reactions Up to Week 54 AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Fecal Calprotectin Baseline and multiple time points up to Week 54 Number of Participants who continue the Therapy After 3 Doses of Vedolizumab After 3 doses of vedolizumab (Week 6 to 14) Number of Participants who have a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab After 3 doses of vedolizumab (Week 6 to 14) Change from Baseline in Complete Mayo Scores Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Complete Mayo score sums 4 sub-scores and ranges from 0 to 12, with higher scores indicating more severe disease.
Change from Baseline in Partial Mayo Scores Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Partial Mayo score sums 3 sub-scores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease.
Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 The SIBDQ is an instrument used to assess quality of life and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score will be reported and is ranging from 10 to 70 with a higher score indicates a better health-related quality of life.
Trial Locations
- Locations (1)
Takeda Selected Site
🇯🇵Tokyo, Japan