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Colitis, UlcerativeNCT04872491

A Study of Vedolizumab in Adults in Real-World Practice

An observational study of Colitis, Ulcerative and Crohn Disease, run by Takeda at 40 sites in China.

Completed

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

Official record
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Trial summary

Vedolizumab is a medicine that is currently prescribed for adults with moderately to severely active ulcerative colitis or Crohn's disease. In this study, adults with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis, Ulcerative, Crohn Disease
Type of treatment
Injection or infusion
How many people
500 participants
Where
40 sitesChina
Study dates
22 Oct 2021to 17 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with UC or CD, who have been prescribed and will start vedolizumab in clinical practice will be observed prospectively.

Who may be able to join

  • Diagnosed with UC or CD
  • Firstly prescribed with vedolizumab

Who cannot join

  • Currently enrolled in or plan to participate in any other clinical trials (that is, interventional study)
  • Contraindicated for vedolizumab according to product package insert

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

China40 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

  • Xiangya Hospital, Central South University

    Changsha, Hu'nan, 410008

  • The Third Xiangya Hospital of Central South University

    Changsha, Hu'nan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing General Hospital

    Chongqing, Chongqing Municipality, 400013

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou, Guangdong, 510120

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310000

  • Zhejiang Provincial Hospital of Chinese Medicine

    Hangzhou, Zhejiang, 310006

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Heilongjiang Provincial Hospital (Nanshang )

    Harbin, Heilongjiang, 150036

  • Huizhou Central People's Hospital

    Huizhou, Guangdong, 516001

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272029

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646099

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210000

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu, 210029

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning, 110004

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong, 518000

  • Suzhou Municipal Hospital Original Region

    Suzhou, Jiangsu, 251002

  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430022

  • The 2nd Hospital of XiAn Jiaotong University

    Xi'an, Shan'xi, 710004

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi’an, Shanxi, 710061

Other trials in China

About this study

Official title: A Prospective, Multicenter, Single-arm, Observational Study to Evaluate the Safety and Effectiveness of Vedolizumab in Real-World Clinical Practice in China

Vedolizumab is a medicine that is currently prescribed for adults with moderately to severely active ulcerative colitis or Crohn's disease.

In this study, adults with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. The main aim of the study is to check if participants have side effects from vedolizumab.

The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

Read the detailed description

This is a non-interventional, prospective study of participants with UC or CD who are prescribed and will start vedolizumab in the real word setting for the first time.

This study will evaluate the safety and effectiveness of vedolizumab in a routine clinical practice setting under real world conditions.

The study will enroll approximately 500 participants. The data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic data capture (eDC). All participants will be enrolled in a single observational group:

  • Participants with UC or CD

This multi-center trial will be conducted in China. The overall duration of the study will be approximately 72 weeks.

Keywords
Drug Therapy
Medical subject headings
Colitis, Ulcerative, Crohn Disease

What participants receive

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

Study groups in NCT04872491
Study groupRoleWhat they receive
Participants With UC or CDParticipants diagnosed with UC or CD who are prescribed and will start treatment with vedolizumab 300 milligram (mg), infusion, intravenously, at Weeks 0, 2, 6, and every 8 weeks thereafter for up to 54 weeks will be observed prospectively for 72 weeks.

What is being measured

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

  1. Percentage of Participants With Adverse Events (AEs)

    Measured: Up to Week 72

  2. Percentage of Participants With Serious Adverse Events (SAEs)

    Measured: Up to Week 72

  3. Percentage of Participants With Adverse Events of Special Interests (AESIs)

    Measured: Up to Week 72

  4. Percentage of Participants With Adverse Drug Reactions (ADRs)

    Measured: Up to Week 72

Secondary outcomes (6)

  1. Percentage of Participants With Ulcerative Colitis (UC) Achieving Clinical Response Based on Partial Mayo Score

    Clinical response in UC is defined as greater than or equal to (>=) 2 points reduction in partial mayo clinic score and >=25 percent (%) decrease from baseline score accompanied with >=1 point decrease in rectal bleeding sub-score or absolute rectal bleeding sub-score less than or equal to (<=) 1 point. Partial mayo score is an instrument designed to measure disease activity of UC. It consists of 3 sub-scores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease.

    Measured: Week 14

  2. Percentage of Participants With Crohn's Disease (CD) Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI)

    Clinical response in CD is defined as >=3-point decrease in the HBI score. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0 equal to [=] very well to 4 = terrible), abdominal pain (0 = none to 3 = severe), number of liquid or soft stools per day, abdominal mass (0 = none to 3 = definite and tender), and complications (8 items; 1 score per item). The total score is sum of sub-scores, where score less than (<) 5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and greater than (>) 16 = severe disease activity.

    Measured: Week 14

  3. Percentage of Participants With UC Achieving Clinical Remission Based on Partial Mayo Score

    Clinical remission in UC is defined as partial mayo clinic score <=2 with no sub-score >1. Partial mayo score is an instrument designed to measure disease activity of UC. It consists of 3 sub-scores: stool frequency, rectal bleeding, and physician rating of disease activity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease.

    Measured: Week 54

  4. Percentage of Participants With CD Achieving Clinical Remission Based on HBI

    Clinical remission in CD is defined as HBI score of <=4 points. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0 = very well to 4 = terrible), abdominal pain (0 = none to 3 = severe), number of liquid or soft stools per day, abdominal mass (0 = none to 3 = definite and tender), and complications (8 items; 1 score per item). The total score is sum of sub-scores, where score <5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and >16 = severe disease activity.

    Measured: Week 54

  5. Percentage of Participants With UC Achieving Endoscopic Remission

    Endoscopic remission in UC is defined as mayo endoscopic sub-score <=1. Mayo endoscopic sub-score (findings on endoscopy), each graded from 0 to 3 where 0 = Normal mucosa or inactive disease, 1 = Mild activity (erythema, decreased vascular pattern, mild friability), 2 = Moderate activity (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe activity (spontaneous bleeding, large ulcerations). Higher scores indicating more severe disease.

    Measured: Week 54

  6. Percentage of Participants With CD Achieving Endoscopic Remission

    Endoscopic remission in CD is defined as absence of any ulcers excluding aphthous ulcers.

    Measured: Week 54

Timeline

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

  1. First posted4 May 2021
  2. Study start22 Oct 2021
  3. Primary completion17 Jul 2024
  4. Study completion17 Jul 2024

Resources

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
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04872491
Sponsor's protocol ID
Vedolizumab-5064
Status last verified
Jul 2024
First submitted
3 May 2021
Last updated
22 Jul 2024
Results posted
No
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Colitis, Ulcerative and Crohn Disease, run by Takeda at 40 sites in China.

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 2 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 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants With Adverse Events (AEs) (time frame: Up to Week 72). The study lists 4 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 NCT04872491.

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 22 Jul 2024.

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