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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Colitis, Ulcerative
• Intervention / Treatment: Drug: Vedolizumab SC

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.

• Study Type: Interventional
• Enrollment (Actual): 746
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1181ACH
      • Hospital Italiano
    • Mar del Plata, Buenos Aires, Argentina, B7600FYK
      • Centro de Investigaciones Medicas Mar Del Plata
  • Ciudad Autonoma Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1120AAC
      • Centro Medico Viamonte SRL
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Hospital Brisbane
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Kurralta Park, South Australia, Australia, 5037
      • Tennyson Centre Day Hospital
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Ballarat Base Hospital
    • Bentleigh East, Victoria, Australia, 3165
      • Monash Medical Centre Clayton
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
    • Malvern, Victoria, Australia, 3144
      • St Frances Xavier Cabrini Hospital
    • Melbourne, Victoria, Australia, 3000
      • Royal Melbourne Hospital
    • Melbourne, Victoria, Australia, 3181
      • The Alfred Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
    • Subiaco, Western Australia, Australia, 6008
      • St John of God Subiaco Hospital
• Belgium
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis
  • Brugge, Belgium, 8310
    • AZ Sint-Lucas
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Kortrijk, Belgium, 8500
    • AZ Groeninge - Kennedylaan
  • Merksem, Belgium, 2170
    • ZNA Jan Palfijn
  • Ottignies, Belgium, 1340
    • Clinique Saint-Pierre
  • Roeselare, Belgium, 8800
    • AZ Delta
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical Centre of the Republic of Srpska
  • Mostar, Bosnia and Herzegovina, 88000
    • University Clinical Hospital Mostar
• Brazil
  • Goias
    • Goiania, Goias, Brazil, 74535-170
      • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • Rio Do Janeiro
    • Rio de Janeiro, Rio Do Janeiro, Brazil, 20270-004
      • HUGG - Hospital Universitario Gaffree e Guinle
    • Rio de Janeiro, Rio Do Janeiro, Brazil, 21941-913
      • HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
      • Hospital São Vicente de Paulo
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618-970
      • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
    • Santo Andre, Sao Paulo, Brazil, 09060-650
      • Faculdade de Medicina do ABC
    • Santos, Sao Paulo, Brazil, 11075-900
      • Irmandade da Santa Casa da Misericórdia de Santos
    • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
      • Fundação Faculdade Regional de Medicina de São José do Rio Preto
• Bulgaria
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Pleven, Bulgaria, 5800
    • "MHAT Avis - Medica" OOD
  • Silistra, Bulgaria, 7500
    • MHAT - Silistra AD
  • Sliven, Bulgaria, 8800
    • MHAT "Hadzhi Dimitar", OOD
  • Sliven, Bulgaria, 8800
    • MC "Tsaritsa Yoanna' EOOD
  • Sofia, Bulgaria, 1407
    • "City Clinic UMHAC" EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
  • Sofia, Bulgaria, 1527
    • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Sofia, Bulgaria, 1606
    • Fourth MHAT - Sofia EAD
  • Sofia, Bulgaria, 1407
    • Medical Center "Excelsior", OOD
  • Sofia, Bulgaria, 1202
    • Second MHAT - Sofia AD
  • Sofia, Bulgaria, 1750
    • UMHAT 'Sveta Anna' AD
  • Sofia, Bulgaria, 1606
    • Military Medical Academy - MHAT - Sofia
  • Stara Zagora, Bulgaria, 6000
    • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2X8
      • Zeidler Ledcor Centre - University of Alberta
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 3M9
      • PerCuro Clinical Research Ltd.
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • LHSC - University Hospital
    • London, Ontario, Canada, N6A 5W9
      • LHSC - Victoria Hospital
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates, Inc.
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Centre Osijek
  • Rijeka, Croatia, 51000
    • Clinical Hospital Centre Rijeka
  • Rijeka, Croatia, 51000
    • Special Hospital Medico
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Clinical Hospital Dubrava
• Czechia
  • Brno, Czechia, 60200
    • CCBR - Czech Brno, s.r.o..
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK s.r.o.
  • Plzen, Czechia, 31200
    • A-SHINE s.r.o.
  • Praha 10, Czechia, 100 00
    • CLINTRIAL s.r.o.
  • Praha 3, Czechia, 13000
    • CCBR Czech Prague, s.r.o.
  • Praha 5, Czechia, 15000
    • Axon Clinical s.r.o.
  • Tabor, Czechia, 39001
    • Nemocnice Tábor a.s.
• Denmark
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
  • Silkeborg, Denmark, 8600
    • Regionshospitalet Silkeborg
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
  • Tartu, Estonia, 50406
    • Tartu University Hospital
• Germany
  • Berlin, Germany, 13353
    • Charité - Campus Virchow-Klinikum
  • Berlin, Germany, 14050
    • DRK Kliniken Berlin Westend
  • Berlin, Germany, 14163
    • Krankenhaus Waldfriede e. V.
  • Bayern
    • Muenchen, Bayern, Germany, 81377
      • LMU - Campus Grosshadern
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Klinikum Der Johann Wolfgang Goethe-Universitaet
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover
  • Nordrhein Westfalen
    • Koeln, Nordrhein Westfalen, Germany, 50937
      • Universitaetsklinikum Koeln
  • Rheinland Pfalz
    • Mainz, Rheinland Pfalz, Germany, 55131
      • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Eugastro GmbH
  • Sachsen Anhalt
    • Magdeburg, Sachsen Anhalt, Germany, 39120
      • Universitaetsklinikum Magdeburg A.oe.R
  • Schleswig Holstein
    • Kiel, Schleswig Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
    • Lubeck, Schleswig Holstein, Germany, 23538
      • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem
  • Budapest, Hungary, 1136
    • Pannonia Maganorvosi Centrum
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft.
  • Budapest, Hungary, 1125
    • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
  • Eger, Hungary, 3300
    • Markhot Ferenc Oktatokorhaz és Rendelointezet
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz
  • Miskolc, Hungary, 3526
    • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
  • Mosonmagyarovar, Hungary, H-9200
    • Karolina Korhaz-Rendelointezet
  • Pecs, Hungary, 7624
    • Pécsi Tudományegyetem
  • Szekesfehervar, Hungary, 8000
    • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Szekszard, Hungary, 7100
    • Tolna Megyei Balassa János Kórház
• Israel
  • Afula, Israel, 18101
    • HaEmek Medical Center
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center
  • Beer Sheva, Israel, 8410101
    • Soroka University Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Holon, Israel, 58100
    • Wolfson Medical Center
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center
  • Nahariya, Israel, 2210001
    • Galilee Medical Center
  • Ramat Gan, Israel, 5265601
    • Chaim Sheba Medical Center
  • Rechovot, Israel, 7610001
    • Kaplan Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Catania, Italy, 95100
    • Azienda Ospedaliera Ospedale Cannizzaro
  • Messina, Italy, 98125
    • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Milano, Italy, 20157
    • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • Modena, Italy, 41124
    • A.O.U. Policlinico di Modena
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria "Federico II"
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Palermo, Italy, 90146
    • Azienda Ospedaliera Vincenzo Cervello
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00152
    • Azienda Ospedaliera San Camillo Forlanini
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas
    • San Donato Milanese, Milano, Italy, 20097
      • I.R.C.C.S Policlinico San Donato
• Japan
  • Aichi-Ken
    • Nagoya-shi, Aichi-Ken, Japan, 460-0022
      • Yokoyama IBD Clinic
  • Chiba-Ken
    • Sakura-shi, Chiba-Ken, Japan, 285-8741
      • Toho University Sakura Medical Center
  • Ehime-Ken
    • Matsuyama-shi, Ehime-Ken, Japan, 790-0024
      • Ehime Prefectural Central Hospital
  • Fukuoka-Ken
    • Chikushino-shi, Fukuoka-Ken, Japan, 818-8502
      • Fukuoka University Chikushi Hospital
    • Fukuoka-shi, Fukuoka-Ken, Japan, 814-0180
      • Fukuoka University Hospital
    • Kurume-shi, Fukuoka-Ken, Japan, 830-0011
      • Kurume University Hospital
  • Hiroshima-Ken
    • Hiroshima-shi, Hiroshima-Ken, Japan, 734-8551
      • Hiroshima University Hospital
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 004-0041
      • Tokushukai Sapporo Tokushukai Hospital
    • Sapporo-shi, Hokkaido, Japan, 060-0033
      • Sapporo-Kosei General Hospital
    • Sapporo-shi, Hokkaido, Japan, 065-0033
      • Tokushukai Sapporo Higashi Tokushukai Hospital
  • Hyogo-Ken
    • Nishinomiya-shi, Hyogo-Ken, Japan, 663-8501
      • Hyogo College of Medicine Hospital
  • Iwate-Ken
    • Morioka-shi, Iwate-Ken, Japan, 020-8505
      • Iwate Medical University Hospital
  • Kagawa-Ken
    • Takamatsu-shi, Kagawa-Ken, Japan, 760-8557
      • Kagawa Prefectural Central Hospital
  • Kanagawa-Ken
    • Kamakura-shi, Kanagawa-Ken, Japan, 247-0056
      • Gokeikai Ofuna Chuo Hospital
  • Okayama-Ken
    • Okayama-shi, Okayama-Ken, Japan, 700-8558
      • Okayama University Hospital
  • Osaka-Fu
    • Osaka-shi, Osaka-Fu, Japan, 530-0011
      • Kinshukai Infusion Clinic
    • Osaka-shi, Osaka-Fu, Japan, 534-0021
      • Osaka City General Hospital
  • Saga-Ken
    • Saga-shi, Saga-Ken, Japan, 849-8501
      • Saga University Hospital
  • Shiga-Ken
    • Otsu-shi, Shiga-Ken, Japan, 520-2192
      • Shiga University of Medical Science Hospital
  • Shizuoka-Ken
    • Hamamatsu-shi, Shizuoka-Ken, Japan, 430-0846
      • Hamamatsu South Hospital
  • Tokyo-To
    • Bunkyo-ku, Tokyo-To, Japan, 113-8519
      • Medical Hospital, Tokyo Medical and Dental University
    • Minato-ku, Tokyo-To, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Minato-ku, Tokyo-To, Japan, 105-8471
      • Jikei University Hospital
    • Mitaka-shi, Tokyo-To, Japan, 181-8611
      • Kyorin University Hospital
    • Shinjuku-ku, Tokyo-To, Japan, 169-0073
      • JCHO Tokyo Yamate Medical Center
    • Shinjuku-ku, Tokyo-To, Japan, 160-8582
      • Keio University Hospital
  • Wakayama-Ken
    • Wakayama-shi, Wakayama-Ken, Japan, 641-8510
      • Wakayama Medical University Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of, 41944
      • Kyungpook National University Hospital
• Lithuania
  • Kaunas, Lithuania, 50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Klaipeda, Lithuania, 92288
    • Klaipeda University Hospital, Public Institution
  • Klaipeda, Lithuania, 92231
    • Klaipeda Republican Hospital, Public Institution
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santariskiu Clinics, Public Institution
• Mexico
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Veracruz, Mexico, 91910
    • Sociedad de Metabolismo y Corazon S.C
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigacion, S.C.
    • Leon, Guanajuato, Mexico, 37520
      • Centro de Investigacion Farmacologica del Bajío, S.C.
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45030
      • iBiomed Guadalajara
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
    • Monterrey, Nuevo Leon, Mexico, 64908
      • Christus Muguerza Sur S.A. de C.V.
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • Dordrecht, Netherlands, 3317 NM
    • Albert Schweitzer Ziekenhuis
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen (UMCG)
  • Maastricht, Netherlands, 6202 AZ
    • Maastricht University Medical Center
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medisch Centrum
• Poland
  • Bialystok, Poland, 15-275
    • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  • Bydgoszcz, Poland, 85-079
    • NZOZ Vitamed
  • Katowice, Poland, 40-752
    • SP CSK im. prof. K. Gibinskiego SUM
  • Krakow, Poland, 31-009
    • Gabinet Endoskopii Przewodu Pokarmowego
  • Lodz, Poland, 90-302
    • SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
  • Lublin, Poland, 20-582
    • Gastromed Sp. z o.o.
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia-Szczecińskie Centrum Medyczne
  • Warszawa, Poland, 03-580
    • NZOZ Vivamed
  • Warszawa, Poland, 02-781
    • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSW w Warszawie
  • Warszawa, Poland, 00-632
    • Centrum Zdrowia MDM
  • Wroclaw, Poland, 53-114
    • LexMedica Osrodek Badan Klinicznych
  • Wroclaw, Poland, 53-333
    • Ars-Medica S.C Rybak Maria, Rybak Zbigniew
• Romania
  • Bucuresti, Romania, 020125
    • Spitalul Clinic Colentina
  • Bucuresti, Romania, 022328
    • Institutul Clinic Fundeni
  • Timisoara, Romania, 300002
    • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
• Russian Federation
  • Kazan, Russian Federation, 420012
    • Kazan State Medical University
  • Krasnoyarsk, Russian Federation, 660022
    • TSBIH "Territorial Clinical Hospital"
  • Moscow, Russian Federation, 119333
    • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
  • Novosibirsk, Russian Federation, 630007
    • LLC "Novosibirsk GastroCenter"
  • Novosibirsk, Russian Federation, 630091
    • SBEIHPE Novosibirsk State Medical University
  • Omsk, Russian Federation, 644013
    • BHI of Omsk region "Clinical Oncology Dispensary"
  • Rostov-on-Don, Russian Federation, 344022
    • SBEI HPE "Rostov State Medical University" of the MoH of the RF
  • Saint-Petersburg, Russian Federation, 197373
    • LLC "RIAT SPb"
  • Sestroretsk, Russian Federation, 197706
    • SPb SBIH "City Hospital # 40 of Kurortnyi region"
  • St. Petersburg, Russian Federation, 195257
    • SPb SBIH "City Hospital of Saint Martyr Elizaveta"
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11080
    • Clinical Center Bezanijska kosa
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • Clinical Helth Centre Zvezdara
  • Belgrade, Serbia, 11080
    • Clinical Center Zemun
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Nis, Serbia, 18000
    • Clinical Center Nis
  • Novi Sad, Serbia, 21000
    • Clinical Center of Vojvodina
• Slovakia
  • Banska Bystrica, Slovakia, 97517
    • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Bratislava, Slovakia, 82606
    • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Kosice, Slovakia, 04001
    • Gastroped s.r.o.
  • Nitra, Slovakia, 949 01
    • KM Management spol. s r.o.
  • Presov, Slovakia, 080 01
    • Gastro I, s.r.o.
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0181
      • Dr CCM Ziady Practice
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7708
      • Dr JP Wright Practice
    • Cape Town, Western Cape, South Africa, 7500
      • Dr MJ Prins Practice
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Dr Josep Trueta
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Pontevedra, Spain, 36164
    • Complejo Hospitalario de Pontevedra
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
• Sweden
  • Stockholm, Sweden, 182 88
    • Danderyds Sjukhus
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset - Solna
• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11490
    • Tri-Service General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
• Turkey
  • Ankara, Turkey, 06100
    • Ankara University Medical Faculty
  • Ankara, Turkey, 06500
    • Gazi University Medical Faculty
  • Istanbul, Turkey, 34349
    • Acibadem Fulya Hospital
  • Istanbul, Turkey, 34668
    • Haydarpasa Numune Training and Research Hospital
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Istanbul, Turkey, 34899
    • Marmara University Pendik Research and Training Hospital
  • Kocaeli, Turkey, 41380
    • Kocaeli Derince Training and Research Hospital
  • Mersin, Turkey, 33343
    • Mersin University Medical Faculty
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • RCNECRCH Dept of Surgery, SHEI Ukr BSMU
  • Dnipro, Ukraine, 49074
    • SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
  • Ivano-Frankivsk, Ukraine, 76008
    • Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
  • Kharkiv, Ukraine, 61037
    • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • Kherson, Ukraine, 73000
    • CI A.and O. Tropiny City Clinical Hospital
  • Kyiv, Ukraine, 1023
    • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • Kyiv, Ukraine, 1023
    • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
  • Kyiv, Ukraine, 1103
    • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  • Lviv, Ukraine, 79059
    • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  • Odesa, Ukraine, 65025
    • CI Odesa Regional Clinical Hospital
  • Ternopil, Ukraine, 46002
    • Ternopil University Hospital
  • Vinnytsia, Ukraine, 21005
    • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
  • Vinnytsia, Ukraine, 21001
    • Private Small Enterprise Medical Center Pulse
  • Vinnytsia, Ukraine, 21009
    • MCIC MC LLC Health Clinic
  • Zaporizhzhia, Ukraine, 69014
    • CI City Hospital #1
• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon and Exeter Hospital (Wonford)
  • Greater London
    • London, Greater London, United Kingdom, NW3 2QG
      • Royal Free Hospital
    • London, Greater London, United Kingdom, E11 1NR
      • Whipps Cross University Hospital
    • London, Greater London, United Kingdom, SW170QT
      • St George's Hospital
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR47UY
      • Norfolk and Norwich University Hospital
  • Shropshire
    • Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
      • Royal Shrewsbury Hospital
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • University Hospital Coventry
    • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
      • Royal Wolverhampton hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85307
      • Arizona Arthritis & Rheumatology Research, PLLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Arkansas Primary Care Clinic, PA
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Rocky Mountain Clinical Research, LLC
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut, LLC
    • Middletown, Connecticut, United States, 06457
      • Middlesex Gastroenterology Associates
  • Florida
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research, LLC
    • Largo, Florida, United States, 33777
      • Florida Center for Gastroenterology
    • Miami, Florida, United States, 33176
      • L & L Research Choices, Inc.
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Pembroke Pines, Florida, United States, 33028
      • BRCR Medical Center, Inc.
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia
    • Suwanee, Georgia, United States, 30024
      • Atlanta Gastroenterology Specialists, PC
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Grand Teton Research Group, PLL
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Tri-State Gastroenterology Associates
    • Owensboro, Kentucky, United States, 42303
      • Research Concierge, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Gastroenterology Associates, LLC
    • Lafayette, Louisiana, United States, 70503
      • Lafayette General Medical Center
    • Shreveport, Louisiana, United States, 71103
      • Louisiana Research Center, LLC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan, P.L.C.
    • Ypsilanti, Michigan, United States, 48197
      • Huron Gastroenterology Associates
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Mississippi
    • Ocean Springs, Mississippi, United States, 39564
      • Digestive Health Center PA
  • Missouri
    • Belton, Missouri, United States, 64012
      • Ehrhardt Clinical Research, LLC
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • AGA Clinical Research Associates, LLC
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley, PC
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
  • Ohio
    • Dayton, Ohio, United States, 45415
      • Dayton Gastroenterology, Inc
    • Lima, Ohio, United States, 45806
      • Gastro-Enterology Research of Lima
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research
  • Pennsylvania
    • Perkasie, Pennsylvania, United States, 18944
      • Main Line Gastroenterology Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastroenterology Center of the MidSouth PC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • San Antonio, Texas, United States, 78212
      • San Antonio Gastroenterology
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Seattle Main Clinic
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Allegiance Research Specialists, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Vedolizumab SC; Vedolizumab SC 108 mg injection
Experimental: 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.	Drug: Vedolizumab SC; Vedolizumab SC 108 mg injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment	AESIs included hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML). 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
Number of Participants With Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response at Week 48	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. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.	Week 48
Number of Participants With Crohn's Disease Achieving Clinical Response Based on Harvey-Bradshaw Index (HBI) Scores at Week 48	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]). As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.	Week 48
Number of Participants With Ulcerative Colitis Achieving Clinical Remission Based on Partial Mayo Score	Clinical remission is defined as a partial Mayo score of ≤2 with no individual subscore >1. As per planned analysis, data for this outcome measure is grouped and presented for participants with ulcerative colitis.	Week 48
Number of Participants With Crohn's Disease Achieving Clinical Remission Based on Harvey-Bradshaw Index (HBI) Scores	Clinical remission is defined as total HBI score of ≤4 points. As per planned analysis, data for this outcome measure is grouped and presented for participants with Crohn's disease.	Week 48

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Medical Director Clinical Science, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2016
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): June 12, 2024

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 30, 2015
• First Posted (Estimated): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Crohn Disease; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: MLN0002SC-3030; U1111-1168-0921 (Registry Identifier: WHO); 2015-000482-31 (EudraCT Number); JapicCTI-163220 (Registry Identifier: JapicCTI); MLN0002SC-3030CTIL (Registry Identifier: Israel); 16/LO/0110 (Registry Identifier: NRES); NL55765.056.16 (Registry Identifier: CCMO); 189751 (Registry Identifier: HC-CTD); 163300410A0052 (Registry Identifier: NREC); MOH_2017-01-05_000040 (Other Identifier: CRS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No