search
Back to results

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

Primary Purpose

Colitis, Ulcerative, Crohn Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Vedolizumab
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Drug Therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study.
  2. In the opinion of the investigator, the participant is continuing to derive benefit from vedolizumab and 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.
  3. A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
  4. A female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.

Exclusion Criteria:

  1. For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement.
  2. Has any clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the participant being in the study.
  3. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period.
  4. If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter.
  5. Has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose.

Sites / Locations

  • The Canberra Hospital
  • Western Hospital
  • Cabrini Medical Centre
  • Box Hill Hospital
  • Royal Brisbane & Women's Hospital
  • Fiona Stanley Hospital
  • Multiprofile Hospital For Active Treatment Ruse
  • City Clinic University Multiprofile Hospital for Active Treatment EOOD
  • Karlovarska krajska nemocnice a.s.
  • Hepato-Gastroenterologie HK, s. r. o.
  • Oblastni nemocnice Kladno, a.s.
  • Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
  • Fakultni nemocnice Kralovske Vinohrady
  • Institut klinicke a experimentalni mediciny
  • ISCARE I.V.F. a.s.
  • Nemocnice Strakonice, a.s.
  • Nemocnice Tabor, a.s.
  • Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem, o.z.
  • West Tallinn Central Hospital
  • East Tallinn Central Hospital
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Bekes Megyei Kozponti Korhaz
  • Peterfy Sandor utcai Korhaz-Rendelintezet es Baleseti Kozpont
  • Semmelweis Egyetem
  • Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
  • Szent Pantaleon Korhaz-Rendelointezet
  • Bugat Pal Korhaz
  • Bekes Megyei Kozponti Korhaz
  • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Karolina Korhaz Rendelointezet
  • Kanizsai Dorottya Korhaz
  • Pecsi Tudomanyegyetem
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Tolna Megyei Balassa Janos Korhaz
  • Owaisi Hospital and Research Centre
  • All India Institute of Medical Sciences
  • Lakeshore Hospital
  • KEM Hospital Research Centre
  • VGM Hospital Institute of Gastroenterology
  • Policlinico San Donato
  • Istituto Clinico Humanitas
  • Yeungnam University Hospital
  • Seoul National University Hospital
  • Severance Hospital Yonsei University Health System - PPDS
  • Kyung Hee University Hospital
  • Samsung Medical Center - PPDS
  • Asan Medical Center - PPDS
  • Pauls Stradins Clinical University Hospital
  • University Malaya Medical Centre
  • Christchurch Hospital
  • Waikato Hospital
  • Shakespeare Specialist Group
  • Ars Medica
  • SP ZOZ Szpital Uniwersytecki w Krakowie
  • Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
  • Centrum Medyczne sw. Lukasza
  • SPZOZ Wojewodzki Szpital Zespolony im J Sniadeckiego
  • 10 Wojskowy Szpital Kliniczny z Poliklinika
  • Corpora-Med
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Centralny Szpital Kliniczny MSW
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
  • Fundeni Clinical Institute
  • Colentina Clinical Hospital
  • City Clinical Hospital #24
  • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
  • Russian Medical Military Academy n.a. S.M. Kirov
  • Medical Company Hepatolog, LLC
  • Union Clinic, LLC
  • St.Petersburg Multi Field City Hospital #2
  • Military Medical Academy
  • CLINRESCO, ARWYP Medical Suites
  • St Augustines Medical Centre
  • Kingsbury Hospital
  • Universitas Hospital
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
  • Medical Clinical Research Center of Medical Center LLC Health Clinic
  • Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vedolizumab 300 mg

Arm Description

Vedolizumab 300 mg, intravenous (IV) infusion, once every 8 weeks until vedolizumab is commercially available. (Per MM approval, dosing regimen may be modified per physician's decision).

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants With Adverse Events of Special Interest (AESIs)

Secondary Outcome Measures

Full Information

First Posted
April 15, 2016
Last Updated
March 10, 2023
Sponsor
Takeda
search

1. Study Identification

Unique Protocol Identification Number
NCT02743806
Brief Title
Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease
Official Title
Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
January 11, 2023 (Actual)
Study Completion Date
January 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to monitor ongoing safety in subjects with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying subjects 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 subject may be expected to develop worsening of disease if they were to modify treatment.
Detailed Description
The drug being used in this study is called vedolizumab, which is being used to treat people who have ulcerative colitis or Crohn's disease. This study will monitor ongoing safety in the people who take vedolizumab. Participants who have successfully completed the participation in qualifying vedolizumab clinical studies will be enrolled and assigned to receive: • Vedolizumab 300 mg All participants will receive an intravenous infusion once every 8 weeks until vedolizumab is available through commercial channels, including reimbursement, for the participant's clinical scenario, or until participant withdrawal, whichever comes first. (Per MM approval, dosing regiman may be modified) This multicenter trial will be conducted worldwide. Participants will make multiple visits to the clinic and a final visit at 18 weeks after receiving the last dose of study infusion of vedolizumab for a safety follow-up assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative, Crohn Disease
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
329 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vedolizumab 300 mg
Arm Type
Experimental
Arm Description
Vedolizumab 300 mg, intravenous (IV) infusion, once every 8 weeks until vedolizumab is commercially available. (Per MM approval, dosing regimen may be modified per physician's decision).
Intervention Type
Drug
Intervention Name(s)
Vedolizumab
Other Intervention Name(s)
MLN0002, Entyvio, Kynteles
Intervention Description
Vedolizumab IV infusion
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
From enrolment until the time the subject exits the study
Title
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Time Frame
From enrolment until the time the subject exits the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study. In the opinion of the investigator, the participant is continuing to derive benefit from vedolizumab and 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. A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. A female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. Exclusion Criteria: For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement. Has any clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the participant being in the study. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period. If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter. Has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Cabrini Medical Centre
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Multiprofile Hospital For Active Treatment Ruse
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
City Clinic University Multiprofile Hospital for Active Treatment EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Karlovarska krajska nemocnice a.s.
City
Karlovy Vary
State/Province
Karlovarsk Kraj
ZIP/Postal Code
360 66
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s. r. o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Oblastni nemocnice Kladno, a.s.
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Institut klinicke a experimentalni mediciny
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
ISCARE I.V.F. a.s.
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Facility Name
Nemocnice Strakonice, a.s.
City
Strakonice
ZIP/Postal Code
386 29
Country
Czechia
Facility Name
Nemocnice Tabor, a.s.
City
Tabor
ZIP/Postal Code
390 03
Country
Czechia
Facility Name
Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem, o.z.
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
EE-10138
Country
Estonia
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Peterfy Sandor utcai Korhaz-Rendelintezet es Baleseti Kozpont
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Szent Pantaleon Korhaz-Rendelointezet
City
Dunaujvaros
ZIP/Postal Code
2400
Country
Hungary
Facility Name
Bugat Pal Korhaz
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Karolina Korhaz Rendelointezet
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Kanizsai Dorottya Korhaz
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Tolna Megyei Balassa Janos Korhaz
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Owaisi Hospital and Research Centre
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500058
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Lakeshore Hospital
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682304
Country
India
Facility Name
KEM Hospital Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
VGM Hospital Institute of Gastroenterology
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641005
Country
India
Facility Name
Policlinico San Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System - PPDS
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Samsung Medical Center - PPDS
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Christchurch Hospital
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Shakespeare Specialist Group
City
Auckland
ZIP/Postal Code
620
Country
New Zealand
Facility Name
Ars Medica
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-333
Country
Poland
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Centrum Medyczne sw. Lukasza
City
Czestochowa
State/Province
Slaskie
ZIP/Postal Code
42-202
Country
Poland
Facility Name
SPZOZ Wojewodzki Szpital Zespolony im J Sniadeckiego
City
Bialystok
ZIP/Postal Code
15-950
Country
Poland
Facility Name
10 Wojskowy Szpital Kliniczny z Poliklinika
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Corpora-Med
City
Gliwice
ZIP/Postal Code
44-122
Country
Poland
Facility Name
Centrum Zdrowia Matki, Dziecka i Mlodziezy
City
Warsaw
ZIP/Postal Code
00-632
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50556
Country
Poland
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
22322
Country
Romania
Facility Name
Colentina Clinical Hospital
City
Bucuresti
ZIP/Postal Code
20125
Country
Romania
Facility Name
City Clinical Hospital #24
City
Moscow
ZIP/Postal Code
125005
Country
Russian Federation
Facility Name
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Russian Medical Military Academy n.a. S.M. Kirov
City
Saint Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Medical Company Hepatolog, LLC
City
Samara
ZIP/Postal Code
443093
Country
Russian Federation
Facility Name
Union Clinic, LLC
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
St.Petersburg Multi Field City Hospital #2
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
CLINRESCO, ARWYP Medical Suites
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
St Augustines Medical Centre
City
Durban
State/Province
Kwazulu - Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Kingsbury Hospital
City
Claremont
State/Province
Western Cape
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Universitas Hospital
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Medical Clinical Research Center of Medical Center LLC Health Clinic
City
Vinnytsia
State/Province
Vinnyts'ka Oblast
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Citations:
PubMed Identifier
33210333
Citation
Danese S, Subramaniam K, Van Zyl J, Adsul S, Lindner D, Roth J, Vermeire S. Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme. Aliment Pharmacol Ther. 2021 Jan;53(2):265-272. doi: 10.1111/apt.16160. Epub 2020 Nov 18.
Results Reference
derived
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b60394db2bf003ab4a23d?idFilter=%5B%22Vedolizumab-4013%22%5D
Description
To obtain more information about this study, click this link.

Learn more about this trial

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

We'll reach out to this number within 24 hrs