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Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vedolizumab SC 108 mg
Placebo
Vedolizumab IV 300 mg
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Drug Therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Diagnosis of CD established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report.

  2. Moderately to severely active CD as determined by a CDAI score of 220 to 450 and 1 of the following:

    • C-reactive protein (CRP) level greater than (>) 2.87 milligram per liter (mg/L) OR
    • Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 centimeter [cm] in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD OR
    • Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening period in conjunction with computed tomography enterography (CTE), magnetic resonance enterography (MRE), contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient).
  3. CD involvement of the ileum and/or colon, at a minimum.
  4. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor necrosis factor-alpha (TNF-α) antagonists.

Exclusion Criteria:

  1. Evidence of abdominal abscess at Screening.
  2. Extensive colonic resection, subtotal or total colectomy.
  3. History of >3 small bowel resections or diagnosis of short bowel syndrome.
  4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
  5. Prior exposure to investigational or approved non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide, or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
  6. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
  7. Prior exposure to vedolizumab.
  8. Surgical intervention for CD required at any time during the study.
  9. History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia.
  10. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
  11. Active infections.
  12. Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or latent), or congenital or acquired immunodeficiency. HBV immune participants (that is, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included.
  13. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.

Sites / Locations

  • Arizona Arthritis & Rheumatology Research, PLLC
  • Medical Research Center of Connecticut, LLC
  • Middlesex Gastroenterology Associates
  • Nature Coast Clinical Research, LLC
  • L & L Research Choices, Inc.
  • Gastroenterology Group of Naples
  • Shafran Gastroenterology Center
  • 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
  • Gastroenterology Associates, LLC
  • 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.
  • Mayo Clinic - Rochester
  • Ehrhardt Clinical Research, LLC
  • Long Island Clinical Research Associates
  • University of North Carolina at Chapel Hill
  • Gastro-Enterology Research of Lima
  • Options Health Research
  • Gastroenterology Center of the MidSouth PC
  • Vanderbilt University Medical Center
  • San Antonio Gastroenterology
  • Allegiance Research Specialists, LLC
  • Concord Repatriation General Hospital
  • Nepean Hospital
  • Royal Adelaide Hospital
  • Tennyson Centre Day Hospital
  • Ballarat Base Hospital
  • Royal Melbourne Hospital
  • The Alfred Hospital
  • Fiona Stanley Hospital
  • St John of God Subiaco Hospital
  • Imeldaziekenhuis
  • Universitair Ziekenhuis Gent
  • AZ Groeninge - Kennedylaan
  • ZNA Jan Palfijn
  • 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 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 "Hadzhi Dimitar", OOD
  • "City Clinic UMHAC" EOOD
  • UMHAT "Sv. Ivan Rilski", EAD
  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Fourth MHAT - Sofia EAD
  • Zeidler Ledcor Centre - University of Alberta
  • PerCuro Clinical Research Ltd.
  • LHSC - University Hospital
  • LHSC - Victoria Hospital
  • Toronto Digestive Disease Associates, Inc.
  • CCBR - Czech Brno, s.r.o..
  • Hepato-Gastroenterologie HK s.r.o.
  • A-SHINE s.r.o.
  • CCBR Czech Prague, s.r.o.
  • Axon Clinical s.r.o.
  • Odense Universitetshospital
  • Regionshospitalet Silkeborg
  • North Estonia Medical Centre Foundation
  • Medizinische Hochschule Hannover
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • EUGASTRO GmbH
  • 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
  • Pest Megyei Flor Ferenc Korhaz
  • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
  • Karolina Korhaz-Rendelointezet
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Tolna Megyei Balassa Janos Korhaz
  • HaEmek Medical Center
  • Soroka University Medical Center
  • Shaare Zedek Medical Center
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • I.R.C.C.S Policlinico San Donato
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Azienda Ospedaliera Ospedale Cannizzaro
  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • A.O.U. Policlinico di Modena
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera Vincenzo Cervello
  • Azienda Ospedaliera San Camillo Forlanini
  • Policlinico Universitario Agostino Gemelli
  • Toho University Sakura Medical Center
  • Fukuoka University Chikushi Hospital
  • Tokushukai Sapporo Tokushukai Hospital
  • Sapporo-Kosei General Hospital
  • Tokushukai Sapporo Higashi Tokushukai Hospital
  • Hyogo College of Medicine Hospital
  • Iwate Medical University Hospital
  • Gokeikai Ofuna Chuo Hospital
  • Kinshukai Infusion Clinic
  • Saga University Hospital
  • Hamamatsu South Hospital
  • Kitasato University Kitasato Institute 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
  • Vilnius University Hospital Santariskiu Clinic, Public Institution
  • Morales Vargas Centro de Investigacion, S.C.
  • Centro de Investigacion Farmacologica del Bajio, S.C.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Sociedad de Metabolismo y Corazon S.C
  • Academisch Medisch Centrum
  • Albert Schweitzer Ziekenhuis, Dordwijk
  • Erasmus Medisch Centrum
  • NZOZ Vitamed
  • 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"
  • SBEIHPE Novosibirsk State Medical University
  • FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
  • BHI of Omsk region Clinical Oncology Dispensary
  • SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
  • 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"
  • SBIH of Yaroslavl region " Regional Clinical Hospital "
  • Clinical Helth Centre Zvezdara
  • Military Medical Academy
  • Clinical Center Bezanijska kosa
  • Clinical Center Kragujevac
  • Clinical Center of Vojvodina
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Dr CCM Ziady Practice
  • Dr JP Wright Practice
  • Karolinska Universitetssjukhuset - Solna
  • Mackay Memorial Hospital
  • Ankara University Medical Faculty
  • Haydarpasa Numune Training and Research Hospital
  • Marmara University Pendik Research and Training Hospital
  • Kocaeli Derince Training and Research Hospital
  • Mersin University Medical Faculty
  • RCI Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
  • SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • CI A.and O. Tropiny City Clinical Hospital
  • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  • CI of Kyiv RC Kyiv Regional Clinical Hospital
  • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
  • 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)
  • St George's Hospital
  • Whipps Cross University Hospital
  • Royal Shrewsbury Hospital
  • University Hospital Coventry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vedolizumab SC 108 mg Maintenance Arm

Placebo SC Maintenance Arm

Arm Description

Open-label Induction: vedolizumab IV 300 milligram (mg), infusion at Week 0 (Day 1) and Week 2 (Day 15) Double-blind Maintenance: vedolizumab SC 108 mg injection once every 2 weeks (Q2W) starting at Week 6 up to Week 50

Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15) Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Clinical Remission at Week 52
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than or equal to (<=) 150 at Week 52. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to (=) sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.

Secondary Outcome Measures

Percentage of Participants Achieving Enhanced Clinical Response at Week 52
Enhanced clinical response is defined as a decrease from Baseline of greater than or equal to (>=) 100 points in the CDAI score at Week 52. A CDAI is a multi-item instrument which measures severity of active CD monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52
Clinical remission is defined as CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.

Full Information

First Posted
November 19, 2015
Last Updated
May 2, 2022
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02611817
Brief Title
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
Official Title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2016 (Actual)
Primary Completion Date
May 6, 2019 (Actual)
Study Completion Date
August 6, 2019 (Actual)

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 purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Detailed Description
The drug being tested in this study is called vedolizumab SC. Vedolizumab SC is being tested to treat people who have moderate to severely active CD. This study will look at clinical remission, as well as enhanced clinical response and corticosteroid-free remission in participants with CD who receive vedolizumab SC maintenance therapy after having achieved a clinical response to vedolizumab IV induction therapy. The study will enroll approximately 824 participants. All participants will enter a 6 week Induction Phase where they will be administered open-label vedolizumab IV 300 mg via IV infusion at Week 0 (Day 1) and Week 2 (Day 15), and will then be assessed for a clinical response at Week 6. Participants who achieve a clinical response at Week 6 will be randomly assigned to one of the two treatment groups: Vedolizumab SC 108 mg Maintenance Arm Placebo SC Maintenance Arm Participants who do not achieve a clinical response will not be randomized into the Maintenance Period, and instead will receive a third infusion of vedolizumab IV 300 mg at Week 6. This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 71 weeks. 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
Crohn's Disease
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
644 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vedolizumab SC 108 mg Maintenance Arm
Arm Type
Experimental
Arm Description
Open-label Induction: vedolizumab IV 300 milligram (mg), infusion at Week 0 (Day 1) and Week 2 (Day 15) Double-blind Maintenance: vedolizumab SC 108 mg injection once every 2 weeks (Q2W) starting at Week 6 up to Week 50
Arm Title
Placebo SC Maintenance Arm
Arm Type
Placebo Comparator
Arm Description
Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15) Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50
Intervention Type
Drug
Intervention Name(s)
Vedolizumab SC 108 mg
Intervention Description
Vedolizumab SC Injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vedolizumab placebo-matching SC injection.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab IV 300 mg
Intervention Description
Vedolizumab IV Injection.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission at Week 52
Description
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than or equal to (<=) 150 at Week 52. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to (=) sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Enhanced Clinical Response at Week 52
Description
Enhanced clinical response is defined as a decrease from Baseline of greater than or equal to (>=) 100 points in the CDAI score at Week 52. A CDAI is a multi-item instrument which measures severity of active CD monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Time Frame
Week 52
Title
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Description
Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Time Frame
Week 52
Title
Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52
Description
Clinical remission is defined as CDAI score <=150 at Week 52. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Time Frame
Week 52

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: Diagnosis of CD established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report. Moderately to severely active CD as determined by a CDAI score of 220 to 450 and 1 of the following: C-reactive protein (CRP) level greater than (>) 2.87 milligram per liter (mg/L) OR Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic ulcerations (each >0.5 centimeter [cm] in diameter) or 10 aphthous ulcerations (involving a minimum of 10 contiguous cm of intestine) consistent with CD OR Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening period in conjunction with computed tomography enterography (CTE), magnetic resonance enterography (MRE), contrast-enhanced small bowel radiography, or wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient). CD involvement of the ileum and/or colon, at a minimum. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor necrosis factor-alpha (TNF-α) antagonists. Exclusion Criteria: Evidence of abdominal abscess at Screening. Extensive colonic resection, subtotal or total colectomy. History of >3 small bowel resections or diagnosis of short bowel syndrome. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. Prior exposure to investigational or approved non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide, or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer). Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer). Prior exposure to vedolizumab. Surgical intervention for CD required at any time during the study. History or evidence of adenomatous colonic polyps that have not been removed, or of colonic mucosal dysplasia. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. Active infections. Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or latent), or congenital or acquired immunodeficiency. HBV immune participants (that is, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
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
45806
Country
United States
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
11021
Country
United States
Facility Name
Middlesex Gastroenterology Associates
City
Middletown
State/Province
Connecticut
Country
United States
Facility Name
Nature Coast Clinical Research, LLC
City
Inverness
State/Province
Florida
ZIP/Postal Code
55905
Country
United States
Facility Name
L & L Research Choices, Inc.
City
Miami
State/Province
Florida
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
30342
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
70809
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
33176
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
53226
Country
United States
Facility Name
Atlanta Gastroenterology Specialists, PC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
48047
Country
United States
Facility Name
Grand Teton Research Group, PLL
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
33028
Country
United States
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
74104
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
06518
Country
United States
Facility Name
Tri-State Gastroenterology Associates
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
06457
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
85307
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
32789
Country
United States
Facility Name
Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, P.L.C.
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
34102
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
30024
Country
United States
Facility Name
Ehrhardt Clinical Research, LLC
City
Belton
State/Province
Missouri
ZIP/Postal Code
60612
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
71105
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
41017
Country
United States
Facility Name
Gastro-Enterology Research of Lima
City
Lima
State/Province
Ohio
ZIP/Postal Code
39581
Country
United States
Facility Name
Options Health Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
83404
Country
United States
Facility Name
Gastroenterology Center of the MidSouth PC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
78212
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
61801
Country
United States
Facility Name
San Antonio Gastroenterology
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Allegiance Research Specialists, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
64012
Country
United States
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
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Tennyson Centre Day Hospital
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Ballarat Base Hospital
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
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
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
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 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 "Hadzhi Dimitar", OOD
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
"City Clinic UMHAC" EOOD
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
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
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
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
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
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
State/Province
Rheinland Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
EUGASTRO GmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
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
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
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
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
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
I.R.C.C.S Policlinico San Donato
City
San Donato Milanese (MI)
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 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 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
Toho University Sakura Medical Center
City
Sakura-shi
State/Province
Chiba-Ken
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
818-8502
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
Gokeikai Ofuna Chuo Hospital
City
Kamakura-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Kinshukai Infusion Clinic
City
Osaka-shi
State/Province
Osaka-Fu
ZIP/Postal Code
530-0011
Country
Japan
Facility Name
Saga University Hospital
City
Saga-shi
State/Province
Saga-Ken
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Hamamatsu South Hospital
City
Hamamatsu-shi
State/Province
Shizuoka-Ken
ZIP/Postal Code
430-0846
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
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
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
Vilnius University Hospital Santariskiu Clinic, 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
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, Dordwijk
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
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
71-270
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
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
SBEIHPE Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
BHI of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
City
Omsk
ZIP/Postal Code
644099
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
SBIH of Yaroslavl region " Regional Clinical Hospital "
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
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 Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
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
Dr CCM Ziady Practice
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
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
Karolinska Universitetssjukhuset - Solna
City
Stockholm
ZIP/Postal Code
11490
Country
Sweden
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Haydarpasa Numune Training and Research Hospital
City
Istanbul
ZIP/Postal Code
01023
Country
Turkey
Facility Name
Marmara University Pendik Research and Training Hospital
City
Istanbul
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Kocaeli Derince Training and Research Hospital
City
Kocaeli
ZIP/Postal Code
34668
Country
Turkey
Facility Name
Mersin University Medical Faculty
City
Mersin
ZIP/Postal Code
34098
Country
Turkey
Facility Name
RCI Chernivtsi RCH Dep of Surgery HSEI of Ukr Bukovinian SMU
City
Chernivtsi
ZIP/Postal Code
21005
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
69104
Country
Ukraine
Facility Name
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
City
Kharkiv
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
CI A.and O. Tropiny City Clinical Hospital
City
Kherson
ZIP/Postal Code
79059
Country
Ukraine
Facility Name
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
City
Kyiv
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
CI of Kyiv RC Kyiv Regional Clinical Hospital
City
Kyiv
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
City
Kyiv
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
City
Lviv
ZIP/Postal Code
01103
Country
Ukraine
Facility Name
CI Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
Ternopil University Hospital
City
Ternopil
ZIP/Postal Code
CV2 2DX
Country
Ukraine
Facility Name
Private Small Enterprise Medical Center Pulse
City
Vinnytsia
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
MCIC MC LLC Health Clinic
City
Vinnytsia
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
CI City Hospital #1
City
Zaporizhzhia
ZIP/Postal Code
EX2 5DW
Country
Ukraine
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
State/Province
Devon
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
St George's Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
31201
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SW170QT
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
State/Province
Shropshire
ZIP/Postal Code
34452
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
NW3 2QG
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/

Learn more about this trial

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

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