Special Drug-Use Surveillance Study on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis]

An observational study of Ulcerative Colitis, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Ulcerative Colitis
What is being tested?: Vedolizumab
Type of treatment: Injection or infusion
How many people: 1,110 participants
Where: 1 siteJapan
Study dates: 1 Feb 2019to 12 Feb 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: UC patients treated with vedolizumab for IV infusion 300 mg as part of routine medical care

Who may be able to join

Have moderate or severe active UC
Have inadequate response to existing therapies

Who cannot join

Patients with any contraindication for vedolizumab

Trial locations and contacts

1 site in 1 country.

Japan1 site

Takeda Selected Site
Tokyo

Other trials in Japan

About this study

Official title: Special Drug-Use Surveillance Study on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]

Read the 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.

Conditions: Ulcerative Colitis
Being tested: Vedolizumab
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VedolizumabDrug
Also called Entyvio for IV Infusion 300 mg
Vedolizumab IV infusion

Study groups in NCT03824561
Study group	Role	What they receive
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 will receive IV infusion as part of routine medical care. Receives: Drug: Vedolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Up to Week 54

Secondary outcomes (5)

Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab
Measured: Week 54
Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201912 Feb 2025

First posted31 Jan 2019
Study start1 Feb 2019
Primary completion12 Feb 2025
Study completion12 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03824561
Sponsor's protocol ID: Vedolizumab-5033
Other IDs: jRCT1080224534
Status last verified: Aug 2025
First submitted: 29 Jan 2019
Last updated: 11 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Matsuoka K, Hisamatsu T, Mikami Y, Yamamoto T, Motoya S, Shinzaki S, Iwakiri R, Sugiura K, Nishimura K, Kajita M, Fernandez JL. Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study. Adv Ther. 2023 Jun;40(6):2902-2914. doi: 10.1007/s12325-023-02500-6. Epub 2023 May 4.
PubMed 37140705

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Drug-Use Surveillance Study on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]
ClinicalTrials.gov ID: NCT03824561
Acronym / sponsor ID: Vedolizumab-5033
Conditions: Ulcerative Colitis
Study type: Observational
Recruitment status: Completed
Enrolment: 1,110 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 1 Feb 2019 (actual)
Primary completion: 12 Feb 2025 (actual)
Study completion: 12 Feb 2025 (actual)
First posted: 31 Jan 2019 (actual)
Results: Posted 11 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 multi-center observational trial will be conducted in Japan.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Vedolizumab 300 mg	–	Drug: VedolizumabVedolizumab 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: UC patients treated with vedolizumab for IV infusion 300 mg as part of routine medical care

Key inclusion criteria (2 listed)

Have moderate or severe active UC
Have inadequate response to existing therapies

Key exclusion criteria (1 listed)

Patients with any contraindication for vedolizumab

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VedolizumabAlso: Entyvio for IV Infusion 300 mgVedolizumab IV infusion	Drug	Vedolizumab 300 mg

Primary outcome

Number of Participants Who Experienced at Least One Adverse Events (AEs)
Time frame: 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
Time frame: 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.

5 secondary outcomes

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
Time frame: Baseline and Week 54
Change From Baseline in Partial Mayo Scores
Time frame: Baseline and Week 54
Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
Time frame: Baseline and Week 54

Results and safety

Results posted to the registry on 11 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vedolizumab 300 mg	1,110	1,091

Primary outcome: Number of Participants Who Experienced at Least One Adverse Events (AEs)

Time frame: Up to Week 54. Count of participants. Unit: Participants

Measure	Vedolizumab 300 mg n = 1091
Value	208

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.

Primary outcome: Number of Participants Who Experienced at Least One Adverse Drug Reactions

Time frame: Up to Week 54. Count of participants. Unit: Participants

Measure	Vedolizumab 300 mg n = 1091
Value	60

Population analysed: Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 54. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vedolizumab 300 mg	82 of 1,091 (7.5%)	29 of 1,091 (2.7%)	5 of 1,091

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37140705Matsuoka K, Hisamatsu T, Mikami Y, Yamamoto T, Motoya S, Shinzaki S, Iwakiri R, Sugiura K, Nishimura K, Kajita M, Fernandez JL. Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study. Adv Ther. 2023 Jun;40(6):2902-2914. doi: 10.1007/s12325-023-02500-6. Epub 2023 May 4.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: 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.

Related trials for Ulcerative Colitis

Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by Takeda at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced at Least One Adverse Events (AEs) (time frame: Up to Week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03824561, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.