Study Stopped
Early Completed - Alternative Source of Drug Available
Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease
Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
3 other identifiers
interventional
331
18 countries
78
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2016
Longer than P75 for phase_4
78 active sites
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
First Submitted
Initial submission to the registry
April 15, 2016
CompletedFirst Posted
Study publicly available on registry
April 19, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2023
CompletedResults Posted
Study results publicly available
November 18, 2023
CompletedNovember 18, 2023
November 1, 2023
6.4 years
April 15, 2016
November 1, 2023
November 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is an important medical event. Percentages are rounded off to the nearest decimal point.
From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
Percentage of Participants With Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. AESIs included serious infections (opportunistic infections, such as progressive multifocal leukoencephalopathy \[PML\]), malignancies, liver injury, infusion-related hypersensitivity reactions, and injection site reactions. Percentages are rounded off to the nearest decimal point.
From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
Study Arms (1)
Vedolizumab 300 mg
EXPERIMENTALVedolizumab 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (78)
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Western Hospital
Footscray, Victoria, 3011, Australia
Cabrini Medical Centre
Malvern, Victoria, 3144, Australia
Box Hill Hospital
Box Hill, 3128, Australia
Royal Brisbane & Women's Hospital
Herston, 4029, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Multiprofile Hospital For Active Treatment Ruse
Rousse, 7002, Bulgaria
City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia, 1784, Bulgaria
Karlovarska krajska nemocnice a.s.
Karlovy Vary, Karlovarsk Kraj, 360 66, Czechia
Hepato-Gastroenterologie HK, s. r. o.
Hradec Králové, 500 12, Czechia
Oblastni nemocnice Kladno, a.s.
Kladno, 272 01, Czechia
Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
Pardubice, 532 03, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Institut klinicke a experimentalni mediciny
Prague, 140 21, Czechia
ISCARE I.V.F. a.s.
Prague, 170 00, Czechia
Nemocnice Strakonice, a.s.
Strakonice, 386 29, Czechia
Nemocnice Tabor, a.s.
Tábor, 390 03, Czechia
Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, 401 13, Czechia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
East Tallinn Central Hospital
Tallinn, EE-10138, Estonia
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, 6720, Hungary
Bekes Megyei Kozponti Korhaz
Békéscsaba, 5600, Hungary
Peterfy Sandor utcai Korhaz-Rendelintezet es Baleseti Kozpont
Budapest, 1076, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
Budapest, 1125, Hungary
Szent Pantaleon Korhaz-Rendelointezet
Dunaújváros, 2400, Hungary
Bugat Pal Korhaz
Gyöngyös, 3200, Hungary
Bekes Megyei Kozponti Korhaz
Gyula, 5700, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Karolina Korhaz Rendelointezet
Mosonmagyaróvár, 9200, Hungary
Kanizsai Dorottya Korhaz
Nagykanizsa, 8800, Hungary
Pecsi Tudomanyegyetem
Pécs, 7624, Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Owaisi Hospital and Research Centre
Hyderabad, Andhra Pradesh, 500058, India
Lakeshore Hospital
Kochi, Kerala, 682304, India
KEM Hospital Research Centre
Pune, Maharashtra, 411011, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
VGM Hospital Institute of Gastroenterology
Coimbatore, Tamil Nadu, 641005, India
Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Pauls Stradins Clinical University Hospital
Riga, LV-1002, Latvia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Christchurch Hospital
Christchurch, Canterbury, 8011, New Zealand
Waikato Hospital
Hamilton, Waikato Region, 3240, New Zealand
Shakespeare Specialist Group
Auckland, 620, New Zealand
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 31-531, Poland
Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Lesser Poland Voivodeship, 31-826, Poland
Ars Medica
Wroclaw, Lower Silesian Voivodeship, 53-333, Poland
Centrum Medyczne sw. Lukasza
Częstochowa, Silesian Voivodeship, 42-202, Poland
SPZOZ Wojewodzki Szpital Zespolony im J Sniadeckiego
Bialystok, 15-950, Poland
10 Wojskowy Szpital Kliniczny z Poliklinika
Bydgoszcz, 85-681, Poland
Corpora-Med
Gliwice, 44-122, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, 00-632, Poland
Centralny Szpital Kliniczny MSW
Warsaw, 02-507, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50556, Poland
Colentina Clinical Hospital
Bucharest, 20125, Romania
Fundeni Clinical Institute
Bucharest, 22322, Romania
City Clinical Hospital #24
Moscow, 125005, Russia
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
Nizhny Novgorod, 603126, Russia
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, 191015, Russia
Union Clinic, LLC
Saint Petersburg, 191119, Russia
St.Petersburg Multi Field City Hospital #2
Saint Petersburg, 194354, Russia
Medical Company Hepatolog, LLC
Samara, 443093, Russia
Military Medical Academy
Belgrade, 11000, Serbia
CLINRESCO, ARWYP Medical Suites
Johannesburg, Gauteng, 1619, South Africa
St Augustines Medical Centre
Durban, KwaZulu-Natal, 4001, South Africa
Kingsbury Hospital
Claremont, Western Cape, 7708, South Africa
Universitas Hospital
Bloemfontein, 9301, South Africa
Yeungnam University Hospital
Daegu, 705-703, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul, 120-752, South Korea
Kyung Hee University Hospital
Seoul, 130-702, South Korea
Samsung Medical Center - PPDS
Seoul, 135-710, South Korea
Asan Medical Center - PPDS
Seoul, 138-736, South Korea
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34890, Turkey (Türkiye)
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsia, Vinnytsia Oblast, 21029, Ukraine
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Poltava, 36011, Ukraine
Related Publications (1)
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.
PMID: 33210333DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2016
First Posted
April 19, 2016
Study Start
August 1, 2016
Primary Completion
January 3, 2023
Study Completion
January 3, 2023
Last Updated
November 18, 2023
Results First Posted
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- 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.
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.