A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
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
10 other identifiers
interventional
746
31 countries
293
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2016
Longer than P75 for phase_3
293 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
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedStudy Start
First participant enrolled
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2024
CompletedResults Posted
Study results publicly available
April 3, 2025
CompletedApril 3, 2025
March 1, 2025
8.2 years
November 19, 2015
March 17, 2025
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
A TEAE was defined as an adverse event (AE) that started or worsened on or after study Day 1 (defined as day first dosed) and no more than 18 weeks after the last dose of study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose and resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event such as acute liver failure, pulmonary hypertension, or confirmed or suspected transmission of an infectious agent by a medicinal product. Participant years is defined as the total exposure-time of the participants in the respective treatment group. Incidence per 100 participant years is defined as (Number of participants with events\*100/participant years). As per planned analysis, data for this outcome measure is grouped and presented per disease condition.
Up to 97.9 months
Secondary Outcomes (5)
Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
Up to 97.9 months
Number of Participants With Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response at Week 48
Week 48
Number of Participants With Crohn's Disease Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) Scores at Week 48
Week 48
Number of Participants With Ulcerative Colitis Achieving Clinical Remission Based on Partial Mayo Score
Week 48
Number of Participants With Crohn's Disease Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI) Scores
Week 48
Study Arms (2)
Ulcerative Colitis: Vedolizumab 108 mg
EXPERIMENTALParticipants 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.
Crohn's Disease: Vedolizumab 108 mg
EXPERIMENTALParticipants 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.
Interventions
Vedolizumab SC 108 mg injection
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study.
- 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.
- Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (301)
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85307, United States
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, 72204, United States
Rocky Mountain Clinical Research, LLC
Wheat Ridge, Colorado, 80033, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Middlesex Gastroenterology Associates
Middletown, Connecticut, 06457, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452, United States
Florida Center for Gastroenterology
Largo, Florida, 33777, United States
L & L Research Choices, Inc.
Miami, Florida, 33176, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
BRCR Medical Center, Inc.
Pembroke Pines, Florida, 33028, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, 30024, United States
Grand Teton Research Group, PLL
Idaho Falls, Idaho, 83404, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606, United States
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky, 41017, United States
Research Concierge, LLC
Owensboro, Kentucky, 42303, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Lafayette General Medical Center
Lafayette, Louisiana, 70503, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103, United States
Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, 48197, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Digestive Health Center PA
Ocean Springs, Mississippi, 39564, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, 64012, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12601, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Dayton Gastroenterology, Inc
Dayton, Ohio, 45415, United States
Gastro-Enterology Research of Lima
Lima, Ohio, 45806, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
Main Line Gastroenterology Associates
Perkasie, Pennsylvania, 18944, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425, United States
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
San Antonio Gastroenterology
San Antonio, Texas, 78212, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Virginia Mason Seattle Main Clinic
Seattle, Washington, 98101, United States
Allegiance Research Specialists, LLC
Milwaukee, Wisconsin, 53226, United States
Hospital Italiano
Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, B7600FYK, Argentina
Centro Medico Viamonte SRL
Buenos Aires, Ciudad Autonoma Buenos Aires, C1120AAC, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Tennyson Centre Day Hospital
Kurralta Park, South Australia, 5037, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3350, Australia
Monash Medical Centre Clayton
Bentleigh East, Victoria, 3165, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
St Frances Xavier Cabrini Hospital
Malvern, Victoria, 3144, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3000, Australia
The Alfred Hospital
Melbourne, Victoria, 3181, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Imeldaziekenhuis
Bonheiden, 2820, Belgium
AZ Sint-Lucas
Bruges, 8310, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
AZ Groeninge - Kennedylaan
Kortrijk, 8500, Belgium
ZNA Jan Palfijn
Merksem, 2170, Belgium
Clinique Saint-Pierre
Ottignies, 1340, Belgium
AZ Delta
Roeselare, 8800, Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar, 88000, Bosnia and Herzegovina
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, Goiás, 74535-170, Brazil
HUGG - Hospital Universitario Gaffree e Guinle
Rio de Janeiro, Rio Do Janeiro, 20270-004, Brazil
HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio Do Janeiro, 21941-913, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-970, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
Irmandade da Santa Casa da Misericordia de Santos
Santos, São Paulo, 11075-900, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
"MHAT Avis - Medica" OOD
Pleven, 5800, Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
MHAT - Silistra AD
Silistra, 7500, Bulgaria
MC "Tsaritsa Yoanna' EOOD
Sliven, 8800, Bulgaria
MHAT "Hadzhi Dimitar", OOD
Sliven, 8800, Bulgaria
Second MHAT - Sofia AD
Sofia, 1202, Bulgaria
"City Clinic UMHAC" EOOD
Sofia, 1407, Bulgaria
Medical Center "Excelsior", OOD
Sofia, 1407, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, 1527, Bulgaria
Fourth MHAT - Sofia EAD
Sofia, 1606, Bulgaria
Military Medical Academy - MHAT - Sofia
Sofia, 1606, Bulgaria
UMHAT 'Sveta Anna' AD
Sofia, 1750, Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, 6000, Bulgaria
Zeidler Ledcor Centre - University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8V 3M9, Canada
LHSC - University Hospital
London, Ontario, N6A 5A5, Canada
LHSC - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4Y7, Canada
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
Clinical Hospital Centre Rijeka
Rijeka, 51000, Croatia
Special Hospital Medico
Rijeka, 51000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
University hospital centre Zagreb
Zagreb, 10000, Croatia
CCBR - Czech Brno, s.r.o..
Brno, 60200, Czechia
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, 500 12, Czechia
A-SHINE s.r.o.
Pilsen, 31200, Czechia
CLINTRIAL s.r.o.
Prague, 100 00, Czechia
CCBR Czech Prague, s.r.o.
Prague, 13000, Czechia
Axon Clinical s.r.o.
Prague, 15000, Czechia
Nemocnice Tabor a.s.
Tábor, 39001, Czechia
Odense Universitetshospital
Odense C, 5000, Denmark
Regionshospitalet Silkeborg
Silkeborg, 8600, Denmark
West Tallinn Central Hospital
Tallinn, 10617, Estonia
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 50406, Estonia
LMU - Campus Grosshadern
Munich, Bavaria, 81377, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt am Main, Hesse, 60590, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
EUGASTRO GmbH
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Magdeburg A.oe.R
Magdeburg, Saxony-Anhalt, 39120, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, Schleswig-Holstein, 23538, Germany
Charite - Campus Virchow-Klinikum
Berlin, 13353, Germany
DRK Kliniken Berlin Westend
Berlin, 14050, Germany
Krankenhaus Waldfriede e. V.
Berlin, 14163, Germany
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, 1125, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, 3300, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula, 5700, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143, Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526, Hungary
Karolina Korhaz-Rendelointezet
Mosonmagyaróvár, H-9200, Hungary
Pecsi Tudomanyegyetem
Pécs, 7624, Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
HaEmek Medical Center
Afula, 18101, Israel
Barzilai Medical Center
Ashkelon, 78278, Israel
Soroka University Medical Center
Beersheba, 8410101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Ospedale Cannizzaro
Catania, 95100, Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, 98125, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, 20157, Italy
A.O.U. Policlinico di Modena
Modena, 41124, Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli, 80131, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Azienda Ospedaliera Vincenzo Cervello
Palermo, 90146, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Yokoyama IBD Clinic
Nagoya, Aichi-ken, 460-0022, Japan
Toho University Sakura Medical Center
Sakura-shi, Chiba, 285-8741, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004-0041, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, 060-0033, Japan
Tokushukai Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033, Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi, Hyōgo, 663-8501, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557, Japan
Gokeikai Ofuna Chuo Hospital
Kamakura-shi, Kanagawa, 247-0056, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Kinshukai Infusion Clinic
Osaka, Osaka, 530-0011, Japan
Osaka City General Hospital
Osaka, Osaka, 534-0021, Japan
Saga University Hospital
Saga, Saga-ken, 849-8501, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
Hamamatsu South Hospital
Hamamatsu, Shizuoka, 430-0846, Japan
Medical Hospital, Tokyo Medical and Dental University
Bunkyō City, Tokyo-To, 113-8519, Japan
Jikei University Hospital
Minatoku, Tokyo-To, 105-8471, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, Tokyo-To, 108-8642, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo-To, 181-8611, Japan
Keio University Hospital
Shinjuku-ku, Tokyo-To, 160-8582, Japan
JCHO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo-To, 169-0073, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, 50009, Lithuania
Klaipeda Republican Hospital, Public Institution
Klaipėda, 92231, Lithuania
Klaipeda University Hospital, Public Institution
Klaipėda, 92288, Lithuania
Vilnius University Hospital Santariskiu Clinics, Public Institution
Vilnius, LT-08661, Lithuania
Morales Vargas Centro de Investigacion, S.C.
León, Guanajuato, 37000, Mexico
Centro de Investigacion Farmacologica del Bajio, S.C.
León, Guanajuato, 37520, Mexico
iBiomed Guadalajara
Zapopan, Jalisco, 45030, Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Christus Muguerza Sur S.A. de C.V.
Monterrey, Nuevo León, 64908, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Sociedad de Metabolismo y Corazon S.C
Veracruz, 91910, Mexico
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3317 NM, Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, 9713 GZ, Netherlands
Maastricht University Medical Center
Maastricht, 6202 AZ, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 CE, Netherlands
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok, 15-275, Poland
NZOZ Vitamed
Bydgoszcz, 85-079, Poland
SP CSK im. prof. K. Gibinskiego SUM
Katowice, 40-752, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
Lodz, 90-153, Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302, Poland
GASTROMED Sp. z o.o.
Lublin, 20-582, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Centrum Zdrowia MDM
Warsaw, 00-632, Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, 02-781, Poland
Nzoz Vivamed
Warsaw, 03-580, Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114, Poland
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
Wroclaw, 53-333, Poland
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, 300002, Romania
Kazan State Medical University
Kazan', 420012, Russia
TSBIH "Territorial Clinical Hospital"
Krasnoyarsk, 660022, Russia
FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
Moscow, 119333, Russia
LLC "Novosibirsk GastroCenter"
Novosibirsk, 630007, Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk, 630091, Russia
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, 644013, Russia
SBEI HPE "Rostov State Medical University" of the MoH of the RF
Rostov-on-Don, 344022, Russia
SPb SBIH "City Hospital of Saint Martyr Elizaveta"
Saint Petersburg, 195257, Russia
LLC "RIAT SPb"
Saint Petersburg, 197373, Russia
SPb SBIH "City Hospital # 40 of Kurortnyi region"
Sestroretsk, 197706, Russia
Clinical Center of Serbia
Belgrade, 11000, Serbia
Clinical Helth Centre Zvezdara
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Center Bezanijska Kosa
Belgrade, 11080, Serbia
Clinical Center Zemun
Belgrade, 11080, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Center Nis
Niš, 18000, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, 97517, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 82606, Slovakia
Gastroped s.r.o.
Košice, 04001, Slovakia
KM Management spol. s r.o.
Nitra, 949 01, Slovakia
Gastro I, s.r.o.
Prešov, 080 01, Slovakia
Dr CCM Ziady Practice
Pretoria, Gauteng, 0181, South Africa
Dr MJ Prins Practice
Cape Town, Western Cape, 7500, South Africa
Dr JP Wright Practice
Cape Town, Western Cape, 7708, South Africa
Kyungpook National University Hospital
Daegu, Gyeongsangbuk-do, 41944, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital, Yonsei University
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, 17007, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Complejo Hospitalario de Pontevedra
Pontevedra, 36164, Spain
Karolinska Universitetssjukhuset - Solna
Stockholm, 171 76, Sweden
Danderyds Sjukhus
Stockholm, 182 88, Sweden
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Ankara University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Acibadem Fulya Hospital
Istanbul, 34349, Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital
Istanbul, 34668, Turkey (Türkiye)
Marmara University Pendik Research and Training Hospital
Istanbul, 34899, Turkey (Türkiye)
Kocaeli Derince Training and Research Hospital
Kocaeli, 41380, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33343, Turkey (Türkiye)
RCNECRCH Dept of Surgery, SHEI Ukr BSMU
Chernivtsi, 58002, Ukraine
SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
Dnipro, 49074, Ukraine
Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76008, Ukraine
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
Kharkiv, 61037, Ukraine
CI A.and O. Tropiny City Clinical Hospital
Kherson, 73000, Ukraine
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, 1023, Ukraine
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
Kyiv, 1023, Ukraine
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
Kyiv, 1103, Ukraine
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv, 79059, Ukraine
CI Odesa Regional Clinical Hospital
Odesa, 65025, Ukraine
Ternopil University Hospital
Ternopil, 46002, Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, 21001, Ukraine
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, 21005, Ukraine
MCIC MC LLC Health Clinic
Vinnytsia, 21009, Ukraine
CI City Hospital #1
Zaporizhzhia, 69014, Ukraine
Royal Devon and Exeter Hospital (Wonford)
Exeter, Devon, EX2 5DW, United Kingdom
Whipps Cross University Hospital
London, Greater London, E11 1NR, United Kingdom
Royal Free Hospital
London, Greater London, NW3 2QG, United Kingdom
St George's Hospital
London, Greater London, SW170QT, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR47UY, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, Shropshire, SY3 8XQ, United Kingdom
University Hospital Coventry
Coventry, West Midlands, CV2 2DX, United Kingdom
Royal Wolverhampton hospital
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Related Publications (1)
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.
PMID: 37492976DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2015
First Posted
December 2, 2015
Study Start
April 15, 2016
Primary Completion
June 12, 2024
Study Completion
June 12, 2024
Last Updated
April 3, 2025
Results First Posted
April 3, 2025
Record last verified: 2025-03
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 provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.