A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02620046
• Other study ID #: MLN0002SC-3030
• Secondary ID: U1111-1168-09212
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 15, 2016
• Est. completion date: June 21, 2024

Study information

• Verified date: May 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis and Crohn's disease. Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC.

Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study.

For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens.

Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study.

After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.

Description:

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating participants with UC or CD. This study will look at the long-term side effects and response/remission of UC and CD in participants who received vedolizumab SC in a prior vedolizumab SC study.

The study will enroll up to 692 patients. All participants enrolled in this study will have previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a clinical response at Week 6 but who did achieve a clinical response at Week 14 after having received a third vedolizumab IV infusion at Week 6 in their previous study, will receive open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early from the Maintenance Period of their previous study due to disease worsening or need for rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW). Participants receiving SC 108 mg Q2W who experience treatment failure (disease worsening or need for rescue medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW.

This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC study will continue until vedolizumab SC becomes commercially available, the participant withdraws from the study, or the sponsor decides to close the study. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 746
• Est. completion date: June 21, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.

Exclusion Criteria:

1. Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study.

2. Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder developed during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise participant safety.

3. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer

Intervention

Drug:
• Vedolizumab SC
Vedolizumab SC 108 mg injection

Locations

Country	Name	City	State
Argentina	Hospital Italiano	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Centro Medico Viamonte SRL	Ciudad Autonoma de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Centro de Investigaciones Medicas Mar del Plata	Mar del Plata	Buenos Aires
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Ballarat Base Hospital	Ballarat	Victoria
Australia	Monash Medical Centre Clayton	Bentleigh East	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	Tennyson Centre Day Hospital	Kurralta Park	South Australia
Australia	St Frances Xavier Cabrini Hospital	Malvern	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Mater Hospital Brisbane	South Brisbane	Queensland
Australia	St John of God Subiaco Hospital	Subiaco	Western Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	AZ Sint-Lucas	Brugge
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	AZ Groeninge - Kennedylaan	Kortrijk
Belgium	ZNA Jan Palfijn	Merksem
Belgium	Clinique Saint-Pierre	Ottignies
Belgium	AZ Delta	Roeselare
Bosnia and Herzegovina	University Clinical Centre of the Republic of Srpska	Banja Luka
Bosnia and Herzegovina	University Clinical Hospital Mostar	Mostar
Brazil	UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu	Botucatu	Sao Paulo
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda	Goiania	Goias
Brazil	Hospital Sao Vicente de Paulo	Passo Fundo	Rio Grande Do Sul
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro	Rio de Janeiro	Rio Do Janeiro
Brazil	HUGG - Hospital Universitario Gaffree e Guinle	Rio de Janeiro	Rio Do Janeiro
Brazil	Faculdade de Medicina do ABC	Santo Andre	Sao Paulo
Brazil	Irmandade da Santa Casa da Misericordia de Santos	Santos	Sao Paulo
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto	Sao Jose do Rio Preto	Sao Paulo
Bulgaria	"MHAT Avis - Medica" OOD	Pleven
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD	Pleven
Bulgaria	MHAT - Silistra AD	Silistra
Bulgaria	MC "Tsaritsa Yoanna' EOOD	Sliven
Bulgaria	MHAT "Hadzhi Dimitar", OOD	Sliven
Bulgaria	"City Clinic UMHAC" EOOD	Sofia
Bulgaria	Fourth MHAT - Sofia EAD	Sofia
Bulgaria	Medical Center "Excelsior", OOD	Sofia
Bulgaria	Military Medical Academy - MHAT - Sofia	Sofia
Bulgaria	Second MHAT - Sofia AD	Sofia
Bulgaria	UMHAT "Sv. Ivan Rilski", EAD	Sofia
Bulgaria	UMHAT 'Sveta Anna' AD	Sofia
Bulgaria	UMHAT 'Tsaritsa Yoanna - ISUL', EAD	Sofia
Bulgaria	Medical Center "Nov Rehabilitatsionen Tsentar", EOOD	Stara Zagora
Canada	Zeidler Ledcor Centre - University of Alberta	Edmonton	Alberta
Canada	LHSC - University Hospital	London	Ontario
Canada	LHSC - Victoria Hospital	London	Ontario
Canada	Toronto Digestive Disease Associates, Inc.	Vaughan	Ontario
Canada	PerCuro Clinical Research Ltd.	Victoria	British Columbia
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	Clinical Hospital Centre Rijeka	Rijeka
Croatia	Special Hospital Medico	Rijeka
Croatia	Clinical Hospital Dubrava	Zagreb
Croatia	University hospital centre Zagreb	Zagreb
Czechia	CCBR - Czech Brno, s.r.o..	Brno
Czechia	Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove
Czechia	A-SHINE s.r.o.	Plzen
Czechia	CLINTRIAL s.r.o.	Praha 10
Czechia	CCBR Czech Prague, s.r.o.	Praha 3
Czechia	Axon Clinical s.r.o.	Praha 5
Czechia	Nemocnice Tabor a.s.	Tabor
Denmark	Odense Universitetshospital	Odense C
Denmark	Regionshospitalet Silkeborg	Silkeborg
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	West Tallinn Central Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
Germany	Charite - Campus Virchow-Klinikum	Berlin
Germany	DRK Kliniken Berlin Westend	Berlin
Germany	Krankenhaus Waldfriede e. V.	Berlin
Germany	Klinikum der Johann Wolfgang Goethe-Universitaet	Frankfurt	Hessen
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Kiel	Kiel	Schleswig Holstein
Germany	Universitaetsklinikum Koeln	Koeln	Nordrhein Westfalen
Germany	EUGASTRO GmbH	Leipzig	Sachsen
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Luebeck	Lubeck	Schleswig Holstein
Germany	Universitaetsklinikum Magdeburg A.oe.R	Magdeburg	Sachsen Anhalt
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz	Mainz	Rheinland Pfalz
Germany	LMU - Campus Grosshadern	Muenchen	Bayern
Hungary	Obudai Egeszsegugyi Centrum Kft.	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak	Budapest
Hungary	Markhot Ferenc Oktatokorhaz es Rendelointezet	Eger
Hungary	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza	Gyula
Hungary	Pest Megyei Flor Ferenc Korhaz	Kistarcsa
Hungary	Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz	Miskolc
Hungary	Karolina Korhaz-Rendelointezet	Mosonmagyarovar
Hungary	Pecsi Tudomanyegyetem	Pecs
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Szekesfehervar
Hungary	Tolna Megyei Balassa Janos Korhaz	Szekszard
Israel	HaEmek Medical Center	Afula
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka University Medical Center	Beer Sheva
Israel	Rambam Health Care Campus	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Galilee Medical Center	Nahariya
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rechovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi	Bologna
Italy	Azienda Ospedaliera Ospedale Cannizzaro	Catania
Italy	Azienda Ospedaliera Universitaria Policlinico G. Martino	Messina
Italy	Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)	Milano
Italy	A.O.U. Policlinico di Modena	Modena
Italy	Azienda Ospedaliera Universitaria "Federico II"	Napoli
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Azienda Ospedaliera Vincenzo Cervello	Palermo
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma
Italy	Policlinico Universitario Agostino Gemelli	Roma
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	I.R.C.C.S Policlinico San Donato	San Donato Milanese	Milano
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo	Foggia
Japan	Medical Hospital, Tokyo Medical and Dental University	Bunkyo-ku	Tokyo-To
Japan	Fukuoka University Chikushi Hospital	Chikushino-shi	Fukuoka-Ken
Japan	Fukuoka University Hospital	Fukuoka-shi	Fukuoka-Ken
Japan	Hamamatsu South Hospital	Hamamatsu-shi	Shizuoka-Ken
Japan	Hiroshima University Hospital	Hiroshima-shi	Hiroshima-Ken
Japan	Gokeikai Ofuna Chuo Hospital	Kamakura-shi	Kanagawa-Ken
Japan	Kurume University Hospital	Kurume-shi	Fukuoka-Ken
Japan	Ehime Prefectural Central Hospital	Matsuyama-shi	Ehime-Ken
Japan	Jikei University Hospital	Minato-ku	Tokyo-To
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo-To
Japan	Kyorin University Hospital	Mitaka-shi	Tokyo-To
Japan	Iwate Medical University Hospital	Morioka-shi	Iwate-Ken
Japan	Yokoyama IBD Clinic	Nagoya-shi	Aichi-Ken
Japan	Hyogo College of Medicine Hospital	Nishinomiya-shi	Hyogo-Ken
Japan	Okayama University Hospital	Okayama-shi	Okayama-Ken
Japan	Kinshukai Infusion Clinic	Osaka-shi	Osaka-Fu
Japan	Osaka City General Hospital	Osaka-shi	Osaka-Fu
Japan	Shiga University of Medical Science Hospital	Otsu-shi	Shiga-Ken
Japan	Saga University Hospital	Saga-shi	Saga-Ken
Japan	Toho University Sakura Medical Center	Sakura-shi	Chiba-Ken
Japan	Sapporo-Kosei General Hospital	Sapporo-shi	Hokkaido
Japan	Tokushukai Sapporo Higashi Tokushukai Hospital	Sapporo-shi	Hokkaido
Japan	Tokushukai Sapporo Tokushukai Hospital	Sapporo-shi	Hokkaido
Japan	JCHO Tokyo Yamate Medical Center	Shinjuku-ku	Tokyo-To
Japan	Keio University Hospital	Shinjuku-ku	Tokyo-To
Japan	Kagawa Prefectural Central Hospital	Takamatsu-shi	Kagawa-Ken
Japan	Wakayama Medical University Hospital	Wakayama-shi	Wakayama-Ken
Korea, Republic of	Kyungpook National University Hospital	Daegu	Gyeongsangbuk-do
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University	Seoul
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas
Lithuania	Klaipeda Republican Hospital, Public Institution	Klaipeda
Lithuania	Klaipeda University Hospital, Public Institution	Klaipeda
Lithuania	Vilnius University Hospital Santariskiu Clinics, Public Institution	Vilnius
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencia A.C.	Durango
Mexico	Centro de Investigacion Farmacologica del Bajio, S.C.	Leon	Guanajuato
Mexico	Morales Vargas Centro de Investigacion, S.C.	Leon	Guanajuato
Mexico	Christus Muguerza Sur S.A. de C.V.	Monterrey	Nuevo Leon
Mexico	Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo Leon
Mexico	Sociedad de Metabolismo y Corazon S.C	Veracruz
Mexico	iBiomed Guadalajara	Zapopan	Jalisco
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Universitair Medisch Centrum Groningen (UMCG)	Groningen
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Medisch Centrum	Rotterdam
Poland	SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego	Bialystok
Poland	NZOZ Vitamed	Bydgoszcz
Poland	SP CSK im. prof. K. Gibinskiego SUM	Katowice
Poland	Gabinet Endoskopii Przewodu Pokarmowego	Krakow
Poland	Santa Familia Centrum Badan, Profilaktyki i Leczenia	Lodz
Poland	SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM	Lodz
Poland	GASTROMED Sp. z o.o.	Lublin
Poland	Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin
Poland	Centralny Szpital Kliniczny MSW w Warszawie	Warszawa
Poland	Centrum Onkologii-Instytut im. M. Sklodowskiej Curie	Warszawa
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Nzoz Vivamed	Warszawa
Poland	Ars-Medica S.C Rybak Maria, Rybak Zbigniew	Wroclaw
Poland	LexMedica Osrodek Badan Klinicznych	Wroclaw
Romania	Institutul Clinic Fundeni	Bucuresti
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	S.C Centrul de Gastroenterologie Dr. Goldis S.R.L	Timisoara
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	TSBIH "Territorial Clinical Hospital"	Krasnoyarsk
Russian Federation	FSBIH "Central Clinical Hospital of Russian Academy of Sciences"	Moscow
Russian Federation	LLC "Novosibirsk GastroCenter"	Novosibirsk
Russian Federation	SBEIHPE Novosibirsk State Medical University	Novosibirsk
Russian Federation	BHI of Omsk region "Clinical Oncology Dispensary"	Omsk
Russian Federation	SBEI HPE "Rostov State Medical University" of the MoH of the RF	Rostov-on-Don
Russian Federation	LLC "RIAT SPb"	Saint-Petersburg
Russian Federation	SPb SBIH "City Hospital # 40 of Kurortnyi region"	Sestroretsk
Russian Federation	SPb SBIH "City Hospital of Saint Martyr Elizaveta"	St. Petersburg
Serbia	Clinical Center Bezanijska Kosa	Belgrade
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Center Zemun	Belgrade
Serbia	Clinical Helth Centre Zvezdara	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Center Nis	Nis
Serbia	Clinical Center of Vojvodina	Novi Sad
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta	Banska Bystrica
Slovakia	Univerzitna nemocnica Bratislava, Nemocnica Ruzinov	Bratislava
Slovakia	Gastroped s.r.o.	Kosice
Slovakia	KM Management spol. s r.o.	Nitra
Slovakia	Gastro I, s.r.o.	Presov
South Africa	Dr JP Wright Practice	Cape Town	Western Cape
South Africa	Dr MJ Prins Practice	Cape Town	Western Cape
South Africa	Dr CCM Ziady Practice	Pretoria	Gauteng
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitari de Girona Dr Josep Trueta	Girona
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Complejo Hospitalario de Pontevedra	Pontevedra
Sweden	Danderyds Sjukhus	Stockholm
Sweden	Karolinska Universitetssjukhuset - Solna	Stockholm
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Acibadem Fulya Hospital	Istanbul
Turkey	Haydarpasa Numune Training and Research Hospital	Istanbul
Turkey	Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty	Istanbul
Turkey	Marmara University Pendik Research and Training Hospital	Istanbul
Turkey	Kocaeli Derince Training and Research Hospital	Kocaeli
Turkey	Mersin University Medical Faculty	Mersin
Ukraine	RCNECRCH Dept of Surgery, SHEI Ukr BSMU	Chernivtsi
Ukraine	SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU	Dnipro
Ukraine	Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU	Ivano-Frankivsk
Ukraine	CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC	Kharkiv
Ukraine	CI A.and O. Tropiny City Clinical Hospital	Kherson
Ukraine	CI of Kyiv RC Kyiv Regional Clinical Hospital	Kyiv
Ukraine	Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU	Kyiv
Ukraine	MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE	Kyiv
Ukraine	Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU	Lviv
Ukraine	CI Odesa Regional Clinical Hospital	Odesa
Ukraine	Ternopil University Hospital	Ternopil
Ukraine	MCIC MC LLC Health Clinic	Vinnytsia
Ukraine	Private Small Enterprise Medical Center Pulse	Vinnytsia
Ukraine	Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU	Vinnytsia
Ukraine	CI City Hospital #1	Zaporizhzhia
United Kingdom	University Hospital Coventry	Coventry	West Midlands
United Kingdom	Royal Devon and Exeter Hospital (Wonford)	Exeter	Devon
United Kingdom	Royal Free Hospital	London	Greater London
United Kingdom	St George's Hospital	London	Greater London
United Kingdom	Whipps Cross University Hospital	London	Greater London
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	Shropshire
United Kingdom	Royal Wolverhampton hospital	Wolverhampton	West Midlands
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Ehrhardt Clinical Research, LLC	Belton	Missouri
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Rush University Medical Center	Chicago	Illinois
United States	Tri-State Gastroenterology Associates	Crestview Hills	Kentucky
United States	Dayton Gastroenterology, Inc	Dayton	Ohio
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	Gastroenterology Center of the MidSouth PC	Germantown	Tennessee
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Medical Research Center of Connecticut, LLC	Hamden	Connecticut
United States	Grand Teton Research Group, PLL	Idaho Falls	Idaho
United States	Nature Coast Clinical Research, LLC	Inverness	Florida
United States	Lafayette General Medical Center	Lafayette	Louisiana
United States	Florida Center for Gastroenterology	Largo	Florida
United States	Gastro-Enterology Research of Lima	Lima	Ohio
United States	Arkansas Primary Care Clinic, PA	Little Rock	Arkansas
United States	Gastroenterology Associates of Central Georgia	Macon	Georgia
United States	L & L Research Choices, Inc.	Miami	Florida
United States	Middlesex Gastroenterology Associates	Middletown	Connecticut
United States	Allegiance Research Specialists, LLC	Milwaukee	Wisconsin
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Digestive Health Center PA	Ocean Springs	Mississippi
United States	Research Concierge, LLC	Owensboro	Kentucky
United States	BRCR Medical Center, Inc.	Pembroke Pines	Florida
United States	Main Line Gastroenterology Associates	Perkasie	Pennsylvania
United States	Arizona Arthritis & Rheumatology Research, PLLC	Phoenix	Arizona
United States	Premier Medical Group of the Hudson Valley, PC	Poughkeepsie	New York
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	San Antonio Gastroenterology	San Antonio	Texas
United States	Virginia Mason Seattle Main Clinic	Seattle	Washington
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Atlanta Gastroenterology Specialists, PC	Suwanee	Georgia
United States	Cotton-O'Neil Clinical Research Center, Digestive Health	Topeka	Kansas
United States	Options Health Research	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Rocky Mountain Clinical Research, LLC	Wheat Ridge	Colorado
United States	Shafran Gastroenterology Center	Winter Park	Florida
United States	Gastroenterology Associates of Western Michigan, P.L.C.	Wyoming	Michigan
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan
United States	Florida Medical Clinic, P.A.	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Croatia,  Czechia,  Denmark,  Estonia,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment	Number of TEAEs and SAEs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of TEAEs and SAEs per 100-participant-years.	From start of study medication through 18 weeks after the last dose
Secondary	Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment	Number of AESIs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of AESIs per 100-participant-years. AESIs include hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML).	From start of study medication through 18 weeks after the last dose
Secondary	Percentage of Participants with Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response	Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and =25% from baseline, with an accompanying decrease in rectal bleeding subscore of =1 point from baseline or absolute rectal bleeding subscore of =1 point.	From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
Secondary	Percentage of Participants with Crohn's Disease Achieving Clinical Response	Clinical response is defined as a decrease in HBI score of =3 points from baseline in CD participants (randomized early terminator CD participants only [defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52]).	From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
Secondary	Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission	Clinical remission is defined as a partial Mayo score of = 2 with no individual subscore >1.	From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, up to 7 years
Secondary	Percentage of Participants with Crohn's Disease (CD) Achieving Clinical Remission	Clinical remission is defined as total HBI score of =4 points in CD participants only (defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52).	From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years

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