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

Primary Purpose

Colitis, Ulcerative, Crohn's Disease

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vedolizumab SC
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Drug therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Arizona Arthritis & Rheumatology Research, PLLC
  • Arkansas Primary Care Clinic, PA
  • Rocky Mountain Clinical Research, LLC
  • Medical Research Center of Connecticut, LLC
  • Middlesex Gastroenterology Associates
  • Nature Coast Clinical Research, LLC
  • Florida Center for Gastroenterology
  • L & L Research Choices, Inc.
  • Gastroenterology Group of Naples
  • BRCR Medical Center, Inc.
  • Shafran Gastroenterology Center
  • Florida Medical Clinic, P.A.
  • Atlanta Gastroenterology Associates
  • Gastroenterology Associates of Central Georgia
  • Atlanta Gastroenterology Specialists, PC
  • Grand Teton Research Group, PLL
  • Rush University Medical Center
  • Carle Foundation Hospital
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Tri-State Gastroenterology Associates
  • Research Concierge, LLC
  • Gastroenterology Associates, LLC
  • Lafayette General Medical Center
  • Louisiana Research Center, LLC
  • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
  • Clinical Research Institute of Michigan, LLC
  • Gastroenterology Associates of Western Michigan, P.L.C.
  • Huron Gastroenterology Associates
  • Mayo Clinic - Rochester
  • Digestive Health Center PA
  • Ehrhardt Clinical Research, LLC
  • AGA Clinical Research Associates, LLC
  • Long Island Clinical Research Associates
  • Premier Medical Group of the Hudson Valley, PC
  • University of North Carolina at Chapel Hill
  • Dayton Gastroenterology, Inc
  • Gastro-Enterology Research of Lima
  • Options Health Research
  • Main Line Gastroenterology Associates
  • Medical University of South Carolina (MUSC)
  • Gastroenterology Center of the MidSouth PC
  • Vanderbilt University Medical Center
  • San Antonio Gastroenterology
  • Tyler Research Institute, LLC
  • Gastroenterology Associates of Tidewater
  • Virginia Mason Seattle Main Clinic
  • Allegiance Research Specialists, LLC
  • Hospital Italiano
  • Centro de Investigaciones Medicas Mar del Plata
  • Centro Medico Viamonte SRL
  • Concord Repatriation General Hospital
  • Nepean Hospital
  • Mater Hospital Brisbane
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Tennyson Centre Day Hospital
  • Ballarat Base Hospital
  • Monash Medical Centre Clayton
  • St Vincent's Hospital Melbourne
  • St Frances Xavier Cabrini Hospital
  • Royal Melbourne Hospital
  • The Alfred Hospital
  • Fiona Stanley Hospital
  • St John of God Subiaco Hospital
  • Imeldaziekenhuis
  • AZ Sint-Lucas
  • Universitair Ziekenhuis Gent
  • AZ Groeninge - Kennedylaan
  • ZNA Jan Palfijn
  • Clinique Saint-Pierre
  • AZ Delta
  • University Clinical Centre of the Republic of Srpska
  • University Clinical Hospital Mostar
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • HUGG - Hospital Universitario Gaffree e Guinle
  • HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
  • Hospital Sao Vicente de Paulo
  • Hospital de Clinicas de Porto Alegre
  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
  • Faculdade de Medicina do ABC
  • Irmandade da Santa Casa da Misericordia de Santos
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • "MHAT Avis - Medica" OOD
  • UMHAT 'Dr. Georgi Stranski', EAD
  • MHAT - Silistra AD
  • MC "Tsaritsa Yoanna' EOOD
  • MHAT "Hadzhi Dimitar", OOD
  • Second MHAT - Sofia AD
  • "City Clinic UMHAC" EOOD
  • Medical Center "Excelsior", OOD
  • UMHAT "Sv. Ivan Rilski", EAD
  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Fourth MHAT - Sofia EAD
  • Military Medical Academy - MHAT - Sofia
  • UMHAT 'Sveta Anna' AD
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  • Zeidler Ledcor Centre - University of Alberta
  • PerCuro Clinical Research Ltd.
  • LHSC - University Hospital
  • LHSC - Victoria Hospital
  • Toronto Digestive Disease Associates, Inc.
  • Clinical Hospital Centre Osijek
  • Clinical Hospital Centre Rijeka
  • Special Hospital Medico
  • Clinical Hospital Dubrava
  • University hospital centre Zagreb
  • CCBR - Czech Brno, s.r.o..
  • Hepato-Gastroenterologie HK s.r.o.
  • A-SHINE s.r.o.
  • CLINTRIAL s.r.o.
  • CCBR Czech Prague, s.r.o.
  • Axon Clinical s.r.o.
  • Nemocnice Tabor a.s.
  • Odense Universitetshospital
  • Regionshospitalet Silkeborg
  • West Tallinn Central Hospital
  • North Estonia Medical Centre Foundation
  • Tartu University Hospital
  • LMU - Campus Grosshadern
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Koeln
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Universitaetsklinikum Magdeburg A.oe.R
  • EUGASTRO GmbH
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
  • Charite - Campus Virchow-Klinikum
  • DRK Kliniken Berlin Westend
  • Krankenhaus Waldfriede e. V.
  • Obudai Egeszsegugyi Centrum Kft.
  • Semmelweis Egyetem
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
  • Pannonia Maganorvosi Centrum
  • Markhot Ferenc Oktatokorhaz es Rendelointezet
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Pest Megyei Flor Ferenc Korhaz
  • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
  • Karolina Korhaz-Rendelointezet
  • Pecsi Tudomanyegyetem
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Tolna Megyei Balassa Janos Korhaz
  • HaEmek Medical Center
  • Barzilai Medical Center
  • Soroka University Medical Center
  • Rambam Health Care Campus
  • Wolfson Medical Center
  • Shaare Zedek Medical Center
  • Galilee Medical Center
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Istituto Clinico Humanitas
  • I.R.C.C.S Policlinico San Donato
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Azienda Ospedaliera Ospedale Cannizzaro
  • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • A.O.U. Policlinico di Modena
  • Azienda Ospedaliera Universitaria "Federico II"
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera Vincenzo Cervello
  • Azienda Ospedaliera San Camillo Forlanini
  • Policlinico Universitario Agostino Gemelli
  • Yokoyama IBD Clinic
  • Toho University Sakura Medical Center
  • Ehime Prefectural Central Hospital
  • Fukuoka University Chikushi Hospital
  • Fukuoka University Hospital
  • Kurume University Hospital
  • Hiroshima University Hospital
  • Tokushukai Sapporo Tokushukai Hospital
  • Sapporo-Kosei General Hospital
  • Tokushukai Sapporo Higashi Tokushukai Hospital
  • Hyogo College of Medicine Hospital
  • Iwate Medical University Hospital
  • Kagawa Prefectural Central Hospital
  • Gokeikai Ofuna Chuo Hospital
  • Okayama University Hospital
  • Kinshukai Infusion Clinic
  • Osaka City General Hospital
  • Saga University Hospital
  • Shiga University of Medical Science Hospital
  • Hamamatsu South Hospital
  • Medical Hospital, Tokyo Medical and Dental University
  • Jikei University Hospital
  • Kitasato University Kitasato Institute Hospital
  • Kyorin University Hospital
  • Keio University Hospital
  • JCHO Tokyo Yamate Medical Center
  • Wakayama Medical University Hospital
  • Kyungpook National University Hospital
  • Yeungnam University Hospital
  • Kyung Hee University Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University
  • Asan Medical Center
  • Samsung Medical Center
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Klaipeda Republican Hospital, Public Institution
  • Klaipeda University Hospital, Public Institution
  • Vilnius University Hospital Santariskiu Clinics, Public Institution
  • Morales Vargas Centro de Investigacion, S.C.
  • Centro de Investigacion Farmacologica del Bajio, S.C.
  • iBiomed Guadalajara
  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Christus Muguerza Sur S.A. de C.V.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Sociedad de Metabolismo y Corazon S.C
  • Academisch Medisch Centrum
  • Albert Schweitzer Ziekenhuis
  • Universitair Medisch Centrum Groningen (UMCG)
  • Maastricht University Medical Center
  • Erasmus Medisch Centrum
  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  • NZOZ Vitamed
  • SP CSK im. prof. K. Gibinskiego SUM
  • Gabinet Endoskopii Przewodu Pokarmowego
  • SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
  • Santa Familia Centrum Badan, Profilaktyki i Leczenia
  • GASTROMED Sp. z o.o.
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Centrum Zdrowia MDM
  • Centralny Szpital Kliniczny MSW w Warszawie
  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Nzoz Vivamed
  • LexMedica Osrodek Badan Klinicznych
  • Ars-Medica S.C Rybak Maria, Rybak Zbigniew
  • Spitalul Clinic Colentina
  • Institutul Clinic Fundeni
  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
  • Kazan State Medical University
  • TSBIH "Territorial Clinical Hospital"
  • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
  • LLC "Novosibirsk GastroCenter"
  • SBEIHPE Novosibirsk State Medical University
  • BHI of Omsk region "Clinical Oncology Dispensary"
  • SBEI HPE "Rostov State Medical University" of the MoH of the RF
  • LLC "RIAT SPb"
  • SPb SBIH "City Hospital # 40 of Kurortnyi region"
  • SPb SBIH "City Hospital of Saint Martyr Elizaveta"
  • Clinical Center of Serbia
  • Clinical Helth Centre Zvezdara
  • Military Medical Academy
  • Clinical Center Bezanijska Kosa
  • Clinical Center Zemun
  • Clinical Center Kragujevac
  • Clinical Center Nis
  • Clinical Center of Vojvodina
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Gastroped s.r.o.
  • KM Management spol. s r.o.
  • Gastro I, s.r.o.
  • Dr CCM Ziady Practice
  • Dr MJ Prins Practice
  • Dr JP Wright Practice
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital General Universitario de Alicante
  • Hospital Universitari de Girona Dr Josep Trueta
  • Hospital Universitario Ramon y Cajal
  • Complejo Hospitalario de Pontevedra
  • Karolinska Universitetssjukhuset - Solna
  • Danderyds Sjukhus
  • National Taiwan University Hospital
  • Mackay Memorial Hospital
  • Tri-Service General Hospital
  • Ankara University Medical Faculty
  • Gazi University Medical Faculty
  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Acibadem Fulya Hospital
  • Haydarpasa Numune Training and Research Hospital
  • Marmara University Pendik Research and Training Hospital
  • Kocaeli Derince Training and Research Hospital
  • Mersin University Medical Faculty
  • RCNECRCH Dept of Surgery, SHEI Ukr BSMU
  • SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
  • Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • CI A.and O. Tropiny City Clinical Hospital
  • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
  • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  • Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
  • CI Odesa Regional Clinical Hospital
  • Ternopil University Hospital
  • Private Small Enterprise Medical Center Pulse
  • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
  • MCIC MC LLC Health Clinic
  • CI City Hospital #1
  • Royal Devon and Exeter Hospital (Wonford)
  • Whipps Cross University Hospital
  • Royal Free Hospital
  • St George's Hospital
  • Norfolk and Norwich University Hospital
  • Royal Shrewsbury Hospital
  • University Hospital Coventry
  • Royal Wolverhampton hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A: Vedolizumab SC 108 mg Q2W

Group B: Vedolizumab SC 108 mg QW

Arm Description

Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who: Completed the Maintenance Period (Week 52), or Were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6.

Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure. •Participants from current study who experience treatment failure while on study.

Outcomes

Primary Outcome Measures

Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
Number of TEAEs and SAEs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of TEAEs and SAEs per 100-participant-years.

Secondary Outcome Measures

Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
Number of AESIs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of AESIs per 100-participant-years. AESIs include hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML).
Percentage of Participants with Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response
Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point from baseline or absolute rectal bleeding subscore of ≤1 point.
Percentage of Participants with Crohn's Disease Achieving Clinical Response
Clinical response is defined as a decrease in HBI score of ≥3 points from baseline in CD participants (randomized early terminator CD participants only [defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52]).
Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission
Clinical remission is defined as a partial Mayo score of ≤ 2 with no individual subscore >1.
Percentage of Participants with Crohn's Disease (CD) Achieving Clinical Remission
Clinical remission is defined as total HBI score of ≤4 points in CD participants only (defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52).

Full Information

First Posted
November 19, 2015
Last Updated
May 19, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02620046
Brief Title
A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
Official Title
A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2016 (Actual)
Primary Completion Date
January 4, 2024 (Anticipated)
Study Completion Date
January 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 and Crohn's disease. Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC. Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study. For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens. Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study. After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative, Crohn's Disease
Keywords
Drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
746 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Vedolizumab SC 108 mg Q2W
Arm Type
Experimental
Arm Description
Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who: Completed the Maintenance Period (Week 52), or Were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6.
Arm Title
Group B: Vedolizumab SC 108 mg QW
Arm Type
Experimental
Arm Description
Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure. •Participants from current study who experience treatment failure while on study.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab SC
Intervention Description
Vedolizumab SC 108 mg injection
Primary Outcome Measure Information:
Title
Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
Description
Number of TEAEs and SAEs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of TEAEs and SAEs per 100-participant-years.
Time Frame
From start of study medication through 18 weeks after the last dose
Secondary Outcome Measure Information:
Title
Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab Treatment
Description
Number of AESIs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of AESIs per 100-participant-years. AESIs include hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML).
Time Frame
From start of study medication through 18 weeks after the last dose
Title
Percentage of Participants with Ulcerative Colitis Achieving Partial Mayo Scoring Clinical Response
Description
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.
Time Frame
From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
Title
Percentage of Participants with Crohn's Disease Achieving Clinical Response
Description
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]).
Time Frame
From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years
Title
Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission
Description
Clinical remission is defined as a partial Mayo score of ≤ 2 with no individual subscore >1.
Time Frame
From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, up to 7 years
Title
Percentage of Participants with Crohn's Disease (CD) Achieving Clinical Remission
Description
Clinical remission is defined as total HBI score of ≤4 points in CD participants only (defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52).
Time Frame
From Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b60274db2bf003ab498d5
Description
To obtain more information on the study, click here/on this link

Learn more about this trial

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

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