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

Last updated: November 1, 2023
Sponsor: Takeda
Overall Status: Terminated

Phase

4

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Vedolizumab

Clinical Study ID

NCT02743806
Vedolizumab-4013
2016-000678-40
U1111-1180-9339
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Received vedolizumab (excluding comparator or placebo participants) duringparticipation in a qualifying vedolizumab study.
  2. In the opinion of the investigator, the participant is continuing to derive benefitfrom vedolizumab and continued treatment with vedolizumab is desired because there isno other comparable product available or the participant may be expected to developworsening of disease if they were to modify treatment.
  3. A male participant who is non-sterilized and sexually active with a female partner ofchildbearing potential agrees to use adequate contraception from signing of informedconsent 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 anon-sterilized male partner agrees to use routinely adequate contraception fromsigning of informed consent throughout the duration of the study and for 18 weeksafter last dose.

Exclusion

Exclusion Criteria:

  1. For the participant's particular clinical scenario, vedolizumab is currently availableto 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 thedosing 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 pregnantbefore, during, or within 18 weeks after participating in this study; or intending todonate ova during such time period.
  4. If male, the participant intends to donate sperm during the course of this study orfor 18 weeks thereafter.
  5. Has received a live vaccine in the last 18 weeks or is in need of a live vaccineduring the study or up to 18 weeks after the last study dose.

Study Design

Total Participants: 331
Treatment Group(s): 1
Primary Treatment: Vedolizumab
Phase: 4
Study Start date:
August 01, 2016
Estimated Completion Date:
January 03, 2023

Study 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 (IV) 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 regimen 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.

Connect with a study center

  • The Canberra Hospital

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • empty

    Brisbane, Queensland
    Australia

    Site Not Available

  • Western Hospital

    Footscray, Victoria 3011
    Australia

    Site Not Available

  • Cabrini Medical Centre

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, 3128
    Australia

    Site Not Available

  • Royal Brisbane & Women's Hospital

    Herston, 4029
    Australia

    Site Not Available

  • Fiona Stanley Hospital

    Murdoch, 6150
    Australia

    Site Not Available

  • Multiprofile Hospital For Active Treatment Ruse

    Ruse, 7002
    Bulgaria

    Site Not Available

  • City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia, 1784
    Bulgaria

    Site Not Available

  • empty

    Praha, Praha, hlavni mesto
    Czech Republic

    Site Not Available

  • Karlovarska krajska nemocnice a.s.

    Karlovy Vary, Karlovarsk Kraj 360 66
    Czechia

    Site Not Available

  • Hepato-Gastroenterologie HK, s. r. o.

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • Oblastni nemocnice Kladno, a.s.

    Kladno, 272 01
    Czechia

    Site Not Available

  • Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

    Pardubice, 532 03
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Institut klinicke a experimentalni mediciny

    Praha 4, 140 21
    Czechia

    Site Not Available

  • ISCARE I.V.F. a.s.

    Praha 7, 170 00
    Czechia

    Site Not Available

  • Nemocnice Strakonice, a.s.

    Strakonice, 386 29
    Czechia

    Site Not Available

  • Nemocnice Tabor, a.s.

    Tabor, 390 03
    Czechia

    Site Not Available

  • Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem, o.z.

    Usti Nad Labem, 401 13
    Czechia

    Site Not Available

  • East Tallinn Central Hospital

    Tallinn, EE-10138
    Estonia

    Site Not Available

  • West Tallinn Central Hospital

    Tallinn, 10617
    Estonia

    Site Not Available

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, Csongrad 6720
    Hungary

    Site Not Available

  • Bekes Megyei Kozponti Korhaz

    Bekescsaba, 5600
    Hungary

    Site Not Available

  • Peterfy Sandor utcai Korhaz-Rendelintezet es Baleseti Kozpont

    Budapest, 1076
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1088
    Hungary

    Site Not Available

  • Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

    Budapest, 1125
    Hungary

    Site Not Available

  • Szent Pantaleon Korhaz-Rendelointezet

    Dunaujvaros, 2400
    Hungary

    Site Not Available

  • Bugat Pal Korhaz

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Bekes Megyei Kozponti Korhaz

    Gyula, 5700
    Hungary

    Site Not Available

  • Somogy Megyei Kaposi Mor Oktato Korhaz

    Kaposvar, 7400
    Hungary

    Site Not Available

  • empty

    Kistarcsa,
    Hungary

    Site Not Available

  • empty

    Miskolc,
    Hungary

    Site Not Available

  • Karolina Korhaz Rendelointezet

    Mosonmagyarovar, 9200
    Hungary

    Site Not Available

  • Kanizsai Dorottya Korhaz

    Nagykanizsa, 8800
    Hungary

    Site Not Available

  • Pecsi Tudomanyegyetem

    Pecs, 7624
    Hungary

    Site Not Available

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Tolna Megyei Balassa Janos Korhaz

    Szekszard, 7100
    Hungary

    Site Not Available

  • Owaisi Hospital and Research Centre

    Hyderabad, Andhra Pradesh 500058
    India

    Site Not Available

  • All India Institute of Medical Sciences

    New Delhi, Delhi 110029
    India

    Site Not Available

  • Lakeshore Hospital

    Kochi, Kerala 682304
    India

    Site Not Available

  • KEM Hospital Research Centre

    Pune, Maharashtra 411011
    India

    Site Not Available

  • VGM Hospital Institute of Gastroenterology

    Coimbatore, Tamil Nadu 641005
    India

    Site Not Available

  • empty

    Napoli, Campania
    Italy

    Site Not Available

  • Policlinico San Donato

    San Donato Milanese, Milano 20097
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • empty

    Roma, Lazio
    Korea, Republic of

    Site Not Available

  • empty

    Padova, Veneto
    Korea, Republic of

    Site Not Available

  • Yeungnam University Hospital

    Daegu, 705-703
    Korea, Republic of

    Site Not Available

  • empty

    Ravenna,
    Korea, Republic of

    Site Not Available

  • empty

    Rozzano (MI),
    Korea, Republic of

    Site Not Available

  • Asan Medical Center - PPDS

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital

    Seoul, 130-702
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center - PPDS

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002
    Latvia

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Christchurch Hospital

    Christchurch, Canterbury 8011
    New Zealand

    Site Not Available

  • Waikato Hospital

    Hamilton, Waikato 3240
    New Zealand

    Site Not Available

  • Shakespeare Specialist Group

    Auckland, 620
    New Zealand

    Site Not Available

  • Ars Medica

    Wroclaw, Dolnoslaskie 53-333
    Poland

    Site Not Available

  • empty

    Krak0w, Malopolskie
    Poland

    Site Not Available

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, Malopolskie 31-531
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    Krakow, Malopolskie 31-826
    Poland

    Site Not Available

  • Centrum Medyczne sw. Lukasza

    Czestochowa, Slaskie 42-202
    Poland

    Site Not Available

  • empty

    Poznan, Wielkopolskie
    Poland

    Site Not Available

  • SPZOZ Wojewodzki Szpital Zespolony im J Sniadeckiego

    Bialystok, 15-950
    Poland

    Site Not Available

  • 10 Wojskowy Szpital Kliniczny z Poliklinika

    Bydgoszcz, 85-681
    Poland

    Site Not Available

  • Corpora-Med

    Gliwice, 44-122
    Poland

    Site Not Available

  • Centrum Zdrowia Matki, Dziecka i Mlodziezy

    Warsaw, 00-632
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny MSW

    Warszawa, 02-507
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50556
    Poland

    Site Not Available

  • Fundeni Clinical Institute

    Bucharest, 22322
    Romania

    Site Not Available

  • Colentina Clinical Hospital

    Bucuresti, 20125
    Romania

    Site Not Available

  • empty

    Lipetsk,
    Russian Federation

    Site Not Available

  • City Clinical Hospital #24

    Moscow, 125005
    Russian Federation

    Site Not Available

  • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

    Nizhniy Novgorod, 603126
    Russian Federation

    Site Not Available

  • empty

    Nizhny Novgorod,
    Russian Federation

    Site Not Available

  • Russian Medical Military Academy n.a. S.M. Kirov

    Saint Petersburg, 191015
    Russian Federation

    Site Not Available

  • Medical Company Hepatolog, LLC

    Samara, 443093
    Russian Federation

    Site Not Available

  • empty

    St Petersburg,
    Russian Federation

    Site Not Available

  • St.Petersburg Multi Field City Hospital #2

    St. Petersburg, 194354
    Russian Federation

    Site Not Available

  • Union Clinic, LLC

    St. Petersburg, 191119
    Russian Federation

    Site Not Available

  • Military Medical Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • empty

    Nitra,
    Slovakia

    Site Not Available

  • empty

    Nove Mesto Nad Vahom,
    Slovakia

    Site Not Available

  • empty

    Presov,
    Slovakia

    Site Not Available

  • CLINRESCO, ARWYP Medical Suites

    Johannesburg, Gauteng 1619
    South Africa

    Site Not Available

  • St Augustines Medical Centre

    Durban, Kwazulu - Natal 4001
    South Africa

    Site Not Available

  • Kingsbury Hospital

    Claremont, Western Cape 7708
    South Africa

    Site Not Available

  • Universitas Hospital

    Bloemfontein, 9301
    South Africa

    Site Not Available

  • empty

    Kaohsiung,
    Taiwan

    Site Not Available

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34890
    Turkey

    Site Not Available

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsia, Vinnyts'ka Oblast 21029
    Ukraine

    Site Not Available

  • Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

    Poltava, 36011
    Ukraine

    Site Not Available

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