Ulcerative Colitis
Conditions
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 study is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have UC. This study 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.
Interventions
DRUGVedolizumab
Vedolizumab IV infusion
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Have moderate or severe active UC 2. Have inadequate response to existing therapies
Exclusion criteria
Patients with any contraindication for vedolizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Events (AEs) | Up to Week 54 | An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. |
| Number of Participants Who Experienced at Least One Adverse Drug Reactions | Up to Week 54 | An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. Adverse drug reaction refers to AE related to administered drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Complete Mayo Scores | Baseline 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 subscores and ranges from 0 to 12, with higher scores indicating more severe disease. |
| Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab | Week 54 | — |
| Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | Baseline and Week 54 | The SIBDQ is an instrument used to assess quality of life (QOL) 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 is ranging from 10 to 70 with a higher score indicates a better health-related quality of life. Change from Baseline in SIBDQ total score was reported. |
| Change From Baseline in Partial Mayo Scores | Baseline 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 subscores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease. |
| Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab | Week 54 | — |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 197 investigative sites in Japan, from 1 February 2019 to 12 February 2025.
Pre-assignment details
Participants with ulcerative colitis who received Vedolizumab IV infusion 300 mg were enrolled. Participants received Vedolizumab IV infusion 300 mg as part of a routine normal practice.
Participants by arm
| Arm | Count |
|---|---|
| Vedolizumab 300 mg Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice. | 1,091 |
| Total | 1,091 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 19 |
Baseline characteristics
| Characteristic | Vedolizumab 300 mg | — |
|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 17.45 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 470 Participants | — |
| Sex: Female, Male Male | 621 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 1,091 |
| other Total, other adverse events | 29 / 1,091 |
| serious Total, serious adverse events | 82 / 1,091 |
Outcome results
Primary
Number of Participants Who Experienced at Least One Adverse Drug Reactions
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. Adverse drug reaction refers to AE related to administered drug.
Time frame: Up to Week 54
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vedolizumab 300 mg | Number of Participants Who Experienced at Least One Adverse Drug Reactions | 60 Participants |
Primary
Number of Participants Who Experienced at Least One Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Time frame: Up to Week 54
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vedolizumab 300 mg | Number of Participants Who Experienced at Least One Adverse Events (AEs) | 208 Participants |
Secondary
Change From Baseline in Complete Mayo Scores
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 subscores and ranges from 0 to 12, with higher scores indicating more severe disease.
Time frame: Baseline and Week 54
Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vedolizumab 300 mg | Change From Baseline in Complete Mayo Scores | -2.1 score on a scale | Standard Deviation 3.67 |
Secondary
Change From Baseline in Partial Mayo Scores
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 subscores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease.
Time frame: Baseline and Week 54
Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vedolizumab 300 mg | Change From Baseline in Partial Mayo Scores | -3.4 score on a scale | Standard Deviation 2.42 |
Secondary
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
The SIBDQ is an instrument used to assess quality of life (QOL) 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 is ranging from 10 to 70 with a higher score indicates a better health-related quality of life. Change from Baseline in SIBDQ total score was reported.
Time frame: Baseline and Week 54
Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vedolizumab 300 mg | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | 9.3 score on a scale | Standard Deviation 12.86 |
Secondary
Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab
Time frame: Week 54
Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vedolizumab 300 mg | Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab | Continued Participants | 880 Participants |
| Vedolizumab 300 mg | Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab | Not Continued Participants | 182 Participants |
Secondary
Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab
Time frame: Week 54
Population: Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vedolizumab 300 mg | Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab | With Presence | 904 Participants |
| Vedolizumab 300 mg | Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab | With Absence | 158 Participants |