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

NCT ID: NCT02743806

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 331 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2023-01-03

Brief 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.

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 (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.

Conditions

Colitis, Ulcerative; Crohn Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vedolizumab 300 mg

Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) that maybe reduced to once every 4 weeks (Q4W) based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years.

Group Type: EXPERIMENTAL

Vedolizumab

Intervention Type: DRUG

Vedolizumab IV infusion

Interventions

Vedolizumab

Vedolizumab IV infusion

Intervention Type: DRUG

Other Intervention Names

MLN0002; Entyvio; Kynteles

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

The Canberra Hospital

Garran, Australian Capital Territory, Australia

Western Hospital

Footscray, Victoria, Australia

Cabrini Medical Centre

Malvern, Victoria, Australia

Box Hill Hospital

Box Hill, , Australia

Royal Brisbane & Women's Hospital

Herston, , Australia

Fiona Stanley Hospital

Murdoch, , Australia

Multiprofile Hospital For Active Treatment Ruse

Rousse, , Bulgaria

City Clinic University Multiprofile Hospital for Active Treatment EOOD

Sofia, , Bulgaria

Karlovarska krajska nemocnice a.s.

Karlovy Vary, Karlovarsk Kraj, Czechia

Hepato-Gastroenterologie HK, s. r. o.

Hradec Králové, , Czechia

Oblastni nemocnice Kladno, a.s.

Kladno, , Czechia

Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

Pardubice, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Institut klinicke a experimentalni mediciny

Prague, , Czechia

ISCARE I.V.F. a.s.

Prague, , Czechia

Nemocnice Strakonice, a.s.

Strakonice, , Czechia

Nemocnice Tabor, a.s.

Tábor, , Czechia

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

Ústí nad Labem, , Czechia

West Tallinn Central Hospital

Tallinn, , Estonia

East Tallinn Central Hospital

Tallinn, , Estonia

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Csongrád megye, Hungary

Bekes Megyei Kozponti Korhaz

Békéscsaba, , Hungary

Peterfy Sandor utcai Korhaz-Rendelintezet es Baleseti Kozpont

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

Budapest, , Hungary

Szent Pantaleon Korhaz-Rendelointezet

Dunaújváros, , Hungary

Bugat Pal Korhaz

Gyöngyös, , Hungary

Bekes Megyei Kozponti Korhaz

Gyula, , Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

Karolina Korhaz Rendelointezet

Mosonmagyaróvár, , Hungary

Kanizsai Dorottya Korhaz

Nagykanizsa, , Hungary

Pecsi Tudomanyegyetem

Pécs, , Hungary

Tolna Megyei Balassa Janos Korhaz

Szekszárd, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

Owaisi Hospital and Research Centre

Hyderabad, Andhra Pradesh, India

Lakeshore Hospital

Kochi, Kerala, India

KEM Hospital Research Centre

Pune, Maharashtra, India

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

VGM Hospital Institute of Gastroenterology

Coimbatore, Tamil Nadu, India

Policlinico San Donato

San Donato Milanese, Milano, Italy

Istituto Clinico Humanitas

Rozzano, , Italy

Pauls Stradins Clinical University Hospital

Riga, , Latvia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Christchurch Hospital

Christchurch, Canterbury, New Zealand

Waikato Hospital

Hamilton, Waikato Region, New Zealand

Shakespeare Specialist Group

Auckland, , New Zealand

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Ars Medica

Wroclaw, Lower Silesian Voivodeship, Poland

Centrum Medyczne sw. Lukasza

Częstochowa, Silesian Voivodeship, Poland

SPZOZ Wojewodzki Szpital Zespolony im J Sniadeckiego

Bialystok, , Poland

10 Wojskowy Szpital Kliniczny z Poliklinika

Bydgoszcz, , Poland

Corpora-Med

Gliwice, , Poland

Centrum Zdrowia Matki, Dziecka i Mlodziezy

Warsaw, , Poland

Centralny Szpital Kliniczny MSW

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, , Poland

Colentina Clinical Hospital

Bucharest, , Romania

Fundeni Clinical Institute

Bucharest, , Romania

City Clinical Hospital #24

Moscow, , Russia

Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

Nizhny Novgorod, , Russia

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

Saint Petersburg, , Russia

Union Clinic, LLC

Saint Petersburg, , Russia

St.Petersburg Multi Field City Hospital #2

Saint Petersburg, , Russia

Medical Company Hepatolog, LLC

Samara, , Russia

Military Medical Academy

Belgrade, , Serbia

CLINRESCO, ARWYP Medical Suites

Johannesburg, Gauteng, South Africa

St Augustines Medical Centre

Durban, KwaZulu-Natal, South Africa

Kingsbury Hospital

Claremont, Western Cape, South Africa

Universitas Hospital

Bloemfontein, , South Africa

Yeungnam University Hospital

Daegu, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System - PPDS

Seoul, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Samsung Medical Center - PPDS

Seoul, , South Korea

Asan Medical Center - PPDS

Seoul, , South Korea

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Medical Clinical Research Center of Medical Center LLC Health Clinic

Vinnytsia, Vinnytsia Oblast, Ukraine

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

Poltava, , Ukraine

Countries

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

References

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.

Reference Type: DERIVED

PMID: 33210333 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b60394db2bf003ab4a23d?idFilter=%5B%22Vedolizumab-4013%22%5D

To obtain more information about this study, click this link.

Other Identifiers

2016-000678-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1180-9339

Identifier Type: REGISTRY

Identifier Source: secondary_id

Vedolizumab-4013

Identifier Type: -

Identifier Source: org_study_id