An observational study in Ulcerative Colitis, sponsored by Takeda. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Takeda · Observational
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.
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.
1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.
This study's enrollment of 1,110 is above the median of 157 across 395 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
UC patients treated with vedolizumab for IV infusion 300 mg as part of routine medical care
Exclusion Criteria:
Patients with any contraindication for 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.
Drug: Vedolizumab
Vedolizumab IV infusion
Also known as: Entyvio for IV Infusion 300 mg
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
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
Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab
Time frame: Week 54
Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab
Time frame: Week 54
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
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
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
Participants took part in the study at 197 investigative sites in Japan, from 1 February 2019 to 12 February 2025.
| Milestone | Vedolizumab 300 mg |
|---|---|
| Started | 1110 |
| Completed | 1091 |
| Not completed | 19 |
| Withdrew: Protocol violation | 19 |
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.
| Participants | Vedolizumab 300 mg |
|---|---|
| Number of Participants Who Experienced at Least One Adverse Events (AEs) | 208 |
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.
| Participants | Vedolizumab 300 mg |
|---|---|
| Number of Participants Who Experienced at Least One Adverse Drug Reactions | 60 |
| Participants | Vedolizumab 300 mg |
|---|---|
| With Presence | 904 |
| With Absence | 158 |
| Participants | Vedolizumab 300 mg |
|---|---|
| Continued Participants | 880 |
| Not Continued Participants | 182 |
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.
| score on a scale | Vedolizumab 300 mg |
|---|---|
| Change From Baseline in Complete Mayo Scores | -2.1 ± 3.67 |
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.
| score on a scale | Vedolizumab 300 mg |
|---|---|
| Change From Baseline in Partial Mayo Scores | -3.4 ± 2.42 |
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.
| score on a scale | Vedolizumab 300 mg |
|---|---|
| Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | 9.3 ± 12.86 |
Collected over Up to Week 54. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vedolizumab 300 mg | 5/1,091 (0.5%) | 82/1,091 (7.5%) | 29/1,091 (2.7%) |
| Event | Vedolizumab 300 mg |
|---|---|
| Colitis ulcerativeGastrointestinal disorders | 37/1091 |
| AppendicitisInfections and infestations | 3/1091 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/1091 |
| AnaemiaBlood and lymphatic system disorders | 3/1091 |
| Metastases to lungNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/1091 |
| Eosinophilic pneumoniaRespiratory, thoracic and mediastinal disorders | 2/1091 |
| PancreatitisGastrointestinal disorders | 2/1091 |
| Bile duct stoneHepatobiliary disorders | 2/1091 |
| Atypical pneumoniaInfections and infestations | 1/1091 |
| GastroenteritisInfections and infestations | 1/1091 |
| Event | Vedolizumab 300 mg |
|---|---|
| NasopharyngitisInfections and infestations | 15/1091 |
| Infusion related reactionInjury, poisoning and procedural complications | 14/1091 |
Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
| Age, Continuous(years) | Vedolizumab 300 mg |
|---|---|
| Mean | 44.3 ± 17.45 |
| Sex: Female, Male(Participants) | Vedolizumab 300 mg |
|---|---|
| Female | 470 |
| Male | 621 |
| Race and Ethnicity Not Collected(Participants) | Vedolizumab 300 mg |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Takeda