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Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

NCT02743806 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2023-11-18

Study results available
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Summary

The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.

Conditions

  • Colitis, Ulcerative
  • Crohn Disease

Interventions

DRUG

Vedolizumab

Vedolizumab IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2023-01-03
Completion
2023-01-03
FDA Drug
Yes

Countries

  • Australia
  • Bulgaria
  • Czechia
  • Estonia
  • Hungary
  • India
  • Italy
  • Latvia
  • Malaysia
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02743806 on ClinicalTrials.gov