Clinical trial NCT02743806: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Colitis, Ulcerative
Crohn Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-04-19
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 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)
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Garran
country: Australia
facility: The Canberra Hospital
state: Australian Capital Territory
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Medical Centre
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Ruse
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Ruse
city: Sofia
country: Bulgaria
facility: City Clinic University Multiprofile Hospital for Active Treatment EOOD
city: Karlovy Vary
country: Czechia
facility: Karlovarska krajska nemocnice a.s.
state: Karlovarsk Kraj
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s. r. o.
city: Kladno
country: Czechia
facility: Oblastni nemocnice Kladno, a.s.
city: Pardubice
country: Czechia
facility: Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 4
country: Czechia
facility: Institut klinicke a experimentalni mediciny
city: Praha 7
country: Czechia
facility: ISCARE I.V.F. a.s.
city: Strakonice
country: Czechia
facility: Nemocnice Strakonice, a.s.
city: Tabor
country: Czechia
facility: Nemocnice Tabor, a.s.
city: Usti Nad Labem
country: Czechia
facility: Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem, o.z.
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
state: Csongrad
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz-Rendelintezet es Baleseti Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
city: Dunaujvaros
country: Hungary
facility: Szent Pantaleon Korhaz-Rendelointezet
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Mosonmagyarovar
country: Hungary
facility: Karolina Korhaz Rendelointezet
city: Nagykanizsa
country: Hungary
facility: Kanizsai Dorottya Korhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Hyderabad
country: India
facility: Owaisi Hospital and Research Centre
state: Andhra Pradesh
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: Kochi
country: India
facility: Lakeshore Hospital
state: Kerala
city: Pune
country: India
facility: KEM Hospital Research Centre
state: Maharashtra
city: Coimbatore
country: India
facility: VGM Hospital Institute of Gastroenterology
state: Tamil Nadu
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
state: Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital
state: Waikato
city: Auckland
country: New Zealand
facility: Shakespeare Specialist Group
city: Wroclaw
country: Poland
facility: Ars Medica
state: Dolnoslaskie
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
state: Malopolskie
city: Krakow
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
state: Malopolskie
city: Czestochowa
country: Poland
facility: Centrum Medyczne sw. Lukasza
state: Slaskie
city: Bialystok
country: Poland
facility: SPZOZ Wojewodzki Szpital Zespolony im J Sniadeckiego
city: Bydgoszcz
country: Poland
facility: 10 Wojskowy Szpital Kliniczny z Poliklinika
city: Gliwice
country: Poland
facility: Corpora-Med
city: Warsaw
country: Poland
facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucuresti
country: Romania
facility: Colentina Clinical Hospital
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #24
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
city: Saint Petersburg
country: Russian Federation
facility: Russian Medical Military Academy n.a. S.M. Kirov
city: Samara
country: Russian Federation
facility: Medical Company Hepatolog, LLC
city: St. Petersburg
country: Russian Federation
facility: Union Clinic, LLC
city: St. Petersburg
country: Russian Federation
facility: St.Petersburg Multi Field City Hospital #2
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Johannesburg
country: South Africa
facility: CLINRESCO, ARWYP Medical Suites
state: Gauteng
city: Durban
country: South Africa
facility: St Augustines Medical Centre
state: Kwazulu - Natal
city: Claremont
country: South Africa
facility: Kingsbury Hospital
state: Western Cape
city: Bloemfontein
country: South Africa
facility: Universitas Hospital
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
city: Vinnytsia
country: Ukraine
facility: Medical Clinical Research Center of Medical Center LLC Health Clinic
state: Vinnyts'ka Oblast
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
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.