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

NCT03824561 | Completed Results

• 2 other identifiers: Vedolizumab-5033jRCT1080224534
• Study Type: observational
• Target: 1,110
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to Week 54

Secondary Outcomes (5)

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

  Week 54

• Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab

  Week 54

• Change From Baseline in Complete Mayo Scores

  Baseline and Week 54

• Change From Baseline in Partial Mayo Scores

  Baseline and Week 54

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

  Baseline and Week 54

Study Arms (1)

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.

Drug: Vedolizumab

Interventions

Vedolizumab DRUG

Vedolizumab IV infusion

Also known as: Entyvio for IV Infusion 300 mg

Vedolizumab 300 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients with any contraindication for vedolizumab

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 37140705 DERIVED

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab; Infusions, Intravenous

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: February 1, 2019
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (1)