NCT04002180

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 Crohn's disease (CD) patients in the routine clinical setting.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jul 2019Jun 2026

First Submitted

Initial submission to the registry

June 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

7 years

First QC Date

June 26, 2019

Last Update Submit

January 4, 2026

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (2)

  • Number of Participants who have One or More Adverse Events

    Adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Up to Week 54

  • Number of Participants who have One or More Adverse Drug Reactions

    AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

    Up to Week 54

Secondary Outcomes (11)

  • Change from Baseline in Crohn's Disease Activity Index (CDAI) Score

    Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)

  • Percentage of Participants with CDAI-100 Response

    Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)

  • Percentage of Participants with CDAI-70 Response

    Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)

  • Percentage of Participants with Clinical Remission

    Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)

  • Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

    Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)

  • +6 more secondary outcomes

Study Arms (1)

Vedolizumab 300 mg

Vedolizumab (Genetical Recombination) 300 mg, IV infusion, 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 (Genetical Recombination)

Interventions

Vedolizumab (Genetical Recombination)DRUG

Vedolizumab IV infusion

Also known as: Entyvio for IV Infusion 300 mg
Vedolizumab 300 mg

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients with any contraindication for vedolizumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

vedolizumabInfusions, Intravenous

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, Parenteral

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 26, 2019

First Posted

June 28, 2019

Study Start

July 1, 2019

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

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.
More information

Locations

JP(1)