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

Crohn Disease Clinical Trial

Official title:

Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02743806
• Other study ID #: Vedolizumab-4013
• Secondary ID: 2016-000678-40U1
• Status: Terminated
• Phase: Phase 4
• Start date: August 1, 2016
• Est. completion date: January 3, 2023

Study information

• Verified date: November 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 331
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Ulcer

Intervention

Drug:
• Vedolizumab
Vedolizumab IV infusion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Australia,  Bulgaria,  Czechia,  Estonia,  Hungary,  India,  Italy,  Korea, Republic of,  Latvia,  Malaysia,  New Zealand,  Poland,  Romania,  Russian Federation,  Serbia,  South Africa,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)

External Links

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