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

NCT ID: NCT02620046

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 746 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-15
• Study Completion Date: 2024-06-12

Brief 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 (UC) and Crohn's disease (CD). 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.

Detailed 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.

Conditions

Colitis, Ulcerative; Crohn's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ulcerative Colitis: Vedolizumab 108 mg

Participants with ulcerative colitis (UC) who completed the Maintenance Phase in MLN0002SC-3027 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3027 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3027 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.

Group Type: EXPERIMENTAL

Vedolizumab SC

Intervention Type: DRUG

Vedolizumab SC 108 mg injection

Crohn's Disease: Vedolizumab 108 mg

Participants with Crohn's disease (CD) who completed the Maintenance Phase in MLN0002SC-3031 (Week 52 assessment) or who did not achieve a clinical response at Week 6 in MLN0002SC-3031 but who did achieve a clinical response at Week 14 of the parent study after having received a third vedolizumab IV infusion at Week 6 in the parent study received vedolizumab SC 108 mg Q2W in this study whereas who withdrew early from the Maintenance Phase (at Week 14 onwards) in MLN0002SC-3031 due to disease worsening or need for rescue medications received vedolizumab SC 108 mg QW.

Group Type: EXPERIMENTAL

Vedolizumab SC

Intervention Type: DRUG

Vedolizumab SC 108 mg injection

Interventions

Vedolizumab SC

Vedolizumab SC 108 mg injection

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Arizona Arthritis & Rheumatology Research, PLLC

Phoenix, Arizona, United States

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, United States

Rocky Mountain Clinical Research, LLC

Wheat Ridge, Colorado, United States

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Middlesex Gastroenterology Associates

Middletown, Connecticut, United States

Nature Coast Clinical Research, LLC

Inverness, Florida, United States

Florida Center for Gastroenterology

Largo, Florida, United States

L & L Research Choices, Inc.

Miami, Florida, United States

Gastroenterology Group of Naples

Naples, Florida, United States

BRCR Medical Center, Inc.

Pembroke Pines, Florida, United States

Shafran Gastroenterology Center

Winter Park, Florida, United States

Florida Medical Clinic, P.A.

Zephyrhills, Florida, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Gastroenterology Associates of Central Georgia

Macon, Georgia, United States

Atlanta Gastroenterology Specialists, PC

Suwanee, Georgia, United States

Grand Teton Research Group, PLL

Idaho Falls, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, United States

Tri-State Gastroenterology Associates

Crestview Hills, Kentucky, United States

Research Concierge, LLC

Owensboro, Kentucky, United States

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, United States

Lafayette General Medical Center

Lafayette, Louisiana, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Gastroenterology Associates of Western Michigan, P.L.C.

Wyoming, Michigan, United States

Huron Gastroenterology Associates

Ypsilanti, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Digestive Health Center PA

Ocean Springs, Mississippi, United States

Ehrhardt Clinical Research, LLC

Belton, Missouri, United States

AGA Clinical Research Associates, LLC

Egg Harbor, New Jersey, United States

Long Island Clinical Research Associates

Great Neck, New York, United States

Premier Medical Group of the Hudson Valley, PC

Poughkeepsie, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Dayton Gastroenterology, Inc

Dayton, Ohio, United States

Gastro-Enterology Research of Lima

Lima, Ohio, United States

Options Health Research

Tulsa, Oklahoma, United States

Main Line Gastroenterology Associates

Perkasie, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Gastroenterology Center of the MidSouth PC

Germantown, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

San Antonio Gastroenterology

San Antonio, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Virginia Mason Seattle Main Clinic

Seattle, Washington, United States

Allegiance Research Specialists, LLC

Milwaukee, Wisconsin, United States

Hospital Italiano

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Centro Medico Viamonte SRL

Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Tennyson Centre Day Hospital

Kurralta Park, South Australia, Australia

Ballarat Base Hospital

Ballarat, Victoria, Australia

Monash Medical Centre Clayton

Bentleigh East, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 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

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia

Imeldaziekenhuis

Bonheiden, , Belgium

AZ Sint-Lucas

Bruges, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

AZ Groeninge - Kennedylaan

Kortrijk, , Belgium

ZNA Jan Palfijn

Merksem, , Belgium

Clinique Saint-Pierre

Ottignies, , Belgium

AZ Delta

Roeselare, , Belgium

University Clinical Centre of the Republic of Srpska

Banja Luka, , Bosnia and Herzegovina

University Clinical Hospital Mostar

Mostar, , Bosnia and Herzegovina

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

Goiânia, Goiás, Brazil

HUGG - Hospital Universitario Gaffree e Guinle

Rio de Janeiro, Rio Do Janeiro, Brazil

HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio Do Janeiro, 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

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, São Paulo, Brazil

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Irmandade da Santa Casa da Misericordia de Santos

Santos, São Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

"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

Second MHAT - Sofia AD

Sofia, , Bulgaria

"City Clinic UMHAC" EOOD

Sofia, , Bulgaria

Medical Center "Excelsior", OOD

Sofia, , Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, , Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

Sofia, , Bulgaria

Fourth MHAT - Sofia EAD

Sofia, , Bulgaria

Military Medical Academy - MHAT - Sofia

Sofia, , Bulgaria

UMHAT 'Sveta Anna' AD

Sofia, , Bulgaria

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

Stara Zagora, , Bulgaria

Zeidler Ledcor Centre - University of Alberta

Edmonton, Alberta, Canada

PerCuro Clinical Research Ltd.

Victoria, British Columbia, Canada

LHSC - University Hospital

London, Ontario, Canada

LHSC - Victoria Hospital

London, Ontario, Canada

Toronto Digestive Disease Associates, Inc.

Vaughan, Ontario, Canada

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, , Croatia

CCBR - Czech Brno, s.r.o..

Brno, , Czechia

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, , Czechia

A-SHINE s.r.o.

Pilsen, , Czechia

CLINTRIAL s.r.o.

Prague, , Czechia

CCBR Czech Prague, s.r.o.

Prague, , Czechia

Axon Clinical s.r.o.

Prague, , Czechia

Nemocnice Tabor a.s.

Tábor, , Czechia

Odense Universitetshospital

Odense C, , Denmark

Regionshospitalet Silkeborg

Silkeborg, , Denmark

West Tallinn Central Hospital

Tallinn, , Estonia

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

LMU - Campus Grosshadern

Munich, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Hesse, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Rhineland-Palatinate, Germany

EUGASTRO GmbH

Leipzig, Saxony, Germany

Universitaetsklinikum Magdeburg A.oe.R

Magdeburg, Saxony-Anhalt, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig-Holstein, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, Schleswig-Holstein, Germany

Charite - Campus Virchow-Klinikum

Berlin, , Germany

DRK Kliniken Berlin Westend

Berlin, , Germany

Krankenhaus Waldfriede e. V.

Berlin, , Germany

Obudai Egeszsegugyi Centrum Kft.

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, , Hungary

Pannonia Maganorvosi Centrum

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

Mosonmagyaróvár, , Hungary

Pecsi Tudomanyegyetem

Pécs, , Hungary

Tolna Megyei Balassa Janos Korhaz

Szekszárd, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

HaEmek Medical Center

Afula, , Israel

Barzilai Medical Center

Ashkelon, , Israel

Soroka University Medical Center

Beersheba, , 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

Rehovot, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

I.R.C.C.S Policlinico San Donato

San Donato Milanese, Milano, 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)

Milan, , Italy

A.O.U. Policlinico di Modena

Modena, , Italy

Azienda Ospedaliera Universitaria "Federico II"

Napoli, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Azienda Ospedaliera Vincenzo Cervello

Palermo, , Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, , Italy

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Yokoyama IBD Clinic

Nagoya, Aichi-ken, Japan

Toho University Sakura Medical Center

Sakura-shi, Chiba, Japan

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Tokushukai Sapporo Tokushukai Hospital

Sapporo, Hokkaido, Japan

Sapporo-Kosei General Hospital

Sapporo, Hokkaido, Japan

Tokushukai Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Hyogo College of Medicine Hospital

Nishinomiya-shi, Hyōgo, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, Japan

Gokeikai Ofuna Chuo Hospital

Kamakura-shi, Kanagawa, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Kinshukai Infusion Clinic

Osaka, Osaka, Japan

Osaka City General Hospital

Osaka, Osaka, Japan

Saga University Hospital

Saga, Saga-ken, Japan

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Hamamatsu South Hospital

Hamamatsu, Shizuoka, Japan

Medical Hospital, Tokyo Medical and Dental University

Bunkyō City, Tokyo-To, Japan

Jikei University Hospital

Minatoku, Tokyo-To, Japan

Kitasato University Kitasato Institute Hospital

Minatoku, Tokyo-To, Japan

Kyorin University Hospital

Mitaka-shi, Tokyo-To, Japan

Keio University Hospital

Shinjuku-ku, Tokyo-To, Japan

JCHO Tokyo Yamate Medical Center

Shinjuku-ku, Tokyo-To, Japan

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Klaipeda Republican Hospital, Public Institution

Klaipėda, , Lithuania

Klaipeda University Hospital, Public Institution

Klaipėda, , Lithuania

Vilnius University Hospital Santariskiu Clinics, Public Institution

Vilnius, , Lithuania

Morales Vargas Centro de Investigacion, S.C.

León, Guanajuato, Mexico

Centro de Investigacion Farmacologica del Bajio, S.C.

León, Guanajuato, Mexico

iBiomed Guadalajara

Zapopan, Jalisco, Mexico

Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Christus Muguerza Sur S.A. de C.V.

Monterrey, Nuevo León, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, , Mexico

Sociedad de Metabolismo y Corazon S.C

Veracruz, , Mexico

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, , Netherlands

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

SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM

Lodz, , Poland

Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, , Poland

GASTROMED Sp. z o.o.

Lublin, , Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, , Poland

Centrum Zdrowia MDM

Warsaw, , Poland

Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, , Poland

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

Warsaw, , Poland

Nzoz Vivamed

Warsaw, , Poland

LexMedica Osrodek Badan Klinicznych

Wroclaw, , Poland

Ars-Medica S.C Rybak Maria, Rybak Zbigniew

Wroclaw, , Poland

Spitalul Clinic Colentina

Bucharest, , Romania

Institutul Clinic Fundeni

Bucharest, , Romania

S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

Timișoara, , Romania

Kazan State Medical University

Kazan', , Russia

TSBIH "Territorial Clinical Hospital"

Krasnoyarsk, , Russia

FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

Moscow, , Russia

LLC "Novosibirsk GastroCenter"

Novosibirsk, , Russia

SBEIHPE Novosibirsk State Medical University

Novosibirsk, , Russia

BHI of Omsk region "Clinical Oncology Dispensary"

Omsk, , Russia

SBEI HPE "Rostov State Medical University" of the MoH of the RF

Rostov-on-Don, , Russia

SPb SBIH "City Hospital of Saint Martyr Elizaveta"

Saint Petersburg, , Russia

LLC "RIAT SPb"

Saint Petersburg, , Russia

SPb SBIH "City Hospital # 40 of Kurortnyi region"

Sestroretsk, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Helth Centre Zvezdara

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinical Center Bezanijska Kosa

Belgrade, , Serbia

Clinical Center Zemun

Belgrade, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Center Nis

Niš, , Serbia

Clinical Center of Vojvodina

Novi Sad, , Serbia

Fakultna nemocnica s poliklinikou F.D. Roosevelta

Banská Bystrica, , Slovakia

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava, , Slovakia

Gastroped s.r.o.

Košice, , Slovakia

KM Management spol. s r.o.

Nitra, , Slovakia

Gastro I, s.r.o.

Prešov, , Slovakia

Dr CCM Ziady Practice

Pretoria, Gauteng, South Africa

Dr MJ Prins Practice

Cape Town, Western Cape, South Africa

Dr JP Wright Practice

Cape Town, Western Cape, South Africa

Kyungpook National University Hospital

Daegu, Gyeongsangbuk-do, South Korea

Yeungnam University Hospital

Daegu, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Universitari de Girona Dr Josep Trueta

Girona, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Complejo Hospitalario de Pontevedra

Pontevedra, , Spain

Karolinska Universitetssjukhuset - Solna

Stockholm, , Sweden

Danderyds Sjukhus

Stockholm, , Sweden

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Acibadem Fulya Hospital

Istanbul, , Turkey (Türkiye)

Haydarpasa Numune Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Marmara University Pendik Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Kocaeli Derince Training and Research Hospital

Kocaeli, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

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

MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

Kyiv, , Ukraine

Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

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

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

MCIC MC LLC Health Clinic

Vinnytsia, , Ukraine

CI City Hospital #1

Zaporizhzhia, , Ukraine

Royal Devon and Exeter Hospital (Wonford)

Exeter, Devon, United Kingdom

Whipps Cross University Hospital

London, Greater London, United Kingdom

Royal Free Hospital

London, Greater London, United Kingdom

St George's Hospital

London, Greater London, United Kingdom

Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, Shropshire, United Kingdom

University Hospital Coventry

Coventry, West Midlands, United Kingdom

Royal Wolverhampton hospital

Wolverhampton, West Midlands, United Kingdom

Countries

United States; Argentina; Australia; Belgium; Bosnia and Herzegovina; Brazil; Bulgaria; Canada; Croatia; Czechia; Denmark; Estonia; Germany; Hungary; Israel; Italy; Japan; Lithuania; Mexico; Netherlands; Poland; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

Ungaro RC, Kadali H, Zhang W, Adsul S, Reinisch W. Impact of Concomitant 5-Aminosalicylic Acid Therapy on Vedolizumab Efficacy and Safety in Inflammatory Bowel Disease: Post Hoc Analyses of Clinical Trial Data. J Crohns Colitis. 2023 Dec 30;17(12):1949-1961. doi: 10.1093/ecco-jcc/jjad113.

Reference Type: DERIVED

PMID: 37492976 (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/5f6b60274db2bf003ab498d5

To obtain more information on the study, click here/on this link

Other Identifiers

U1111-1168-0921

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-000482-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

JapicCTI-163220

Identifier Type: REGISTRY

Identifier Source: secondary_id

MLN0002SC-3030CTIL

Identifier Type: REGISTRY

Identifier Source: secondary_id

16/LO/0110

Identifier Type: REGISTRY

Identifier Source: secondary_id

NL55765.056.16

Identifier Type: REGISTRY

Identifier Source: secondary_id

189751

Identifier Type: REGISTRY

Identifier Source: secondary_id

163300410A0052

Identifier Type: REGISTRY

Identifier Source: secondary_id

MOH_2017-01-05_000040

Identifier Type: OTHER

Identifier Source: secondary_id

MLN0002SC-3030

Identifier Type: -

Identifier Source: org_study_id