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Completed

NCT Number: NCT03824561

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients with any contraindication for vedolizumab

Treatment and study plan

Vedolizumab

Drug

Vedolizumab IV infusion

Other names: Entyvio for IV Infusion 300 mg

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab

    Time frame: Week 54

  2. Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab

    Time frame: Week 54

  3. Change From Baseline in Complete Mayo Scores

    Time frame: 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.

  4. Change From Baseline in Partial Mayo Scores

    Time frame: 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.

  5. Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2019
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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