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An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02497469
Recruitment Status : Completed
First Posted : July 14, 2015
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Drug: Vedolizumab Drug: Adalimumab placebo Drug: Adalimumab Drug: Vedolizumab placebo Phase 3

Detailed Description:

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis. This study will look at the stool frequency, rectal bleeding and findings on endoscopy of people who take vedolizumab compared to those who take adalimumab.

The study will enroll approximately 658 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Vedolizumab 300 mg IV
  • Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC

All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every 2 weeks for up to Week 50. All participants will be asked to record the symptoms of ulcerative colitis in a daily diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 771 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
Actual Study Start Date : July 15, 2015
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : January 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vedolizumab IV 300 mg
Vedolizumab 300 milligram (mg), infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
Drug: Vedolizumab
Vedolizumab infusion

Drug: Adalimumab placebo
Adalimumab placebo-matching injection

Active Comparator: Adalimumab SC 160/80/40 mg
Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.
Drug: Adalimumab
Adalimumab injection

Drug: Vedolizumab placebo
Vedolizumab placebo-matching infusion




Primary Outcome Measures :
  1. Percentage of Participants Who Achieved Clinical Remission [ Time Frame: Week 52 ]
    Clinical remission was defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).


Secondary Outcome Measures :
  1. Percentage of Participants Who Achieved Mucosal Healing [ Time Frame: Week 52 ]
    Mucosal healing was defined as a Mayo score endoscopic subscore of <= 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).

  2. Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission [ Time Frame: Week 52 ]
    Corticosteroid-free remission was defined as participants using oral corticosteroids at Baseline (Week 0) who had discontinued oral corticosteroids and were in clinical remission at Week 52. Clinical remission was defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has a diagnosis of ulcerative colitis established at least 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
  2. Has moderately to severely active ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore greater than or equal to >=2 within 14 days prior to the randomization.
  3. Has evidence of ulcerative colitis proximal to the rectum (>=15 centimeter [cm] of involved colon).
  4. With extensive colitis (up to the hepatic flexure) or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during the Screening Period).
  5. The participant:

    1. Has had previous treatment with tumor necrosis factor- alpha (TNF-alpha) antagonists without documented clinical response to treatment (example, due to lack of response [primary nonresponders], loss of response, or intolerance [secondary nonresponders]), or
    2. Has previously used a TNF-alpha antagonists (except adalimumab), and discontinued its use due to reasons other than safety, or
    3. Is naïve to TNF-alpha antagonist therapy but is failing current treatment (example, corticosteroids, 5-aminosalicylate [5-ASA], or immunomodulators).

Exclusion Criteria:

  1. Clinical evidence of abdominal abscess or toxic megacolon at Screening.
  2. Has had an extensive colonic resection, subtotal or total colectomy.
  3. Has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
  4. Has a diagnosis of Crohn's colitis or indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
  5. Has received any of the following for the treatment of underlying disease within 30 days of randomization:

    1. Non-biologic therapies (example, cyclosporine, tacrolimus, thalidomide) other than those specifically listed in Section Permitted Medications For Treatment of UC.
    2. An approved non-biologic therapy in an investigational protocol.
  6. Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to the screening (whichever is longer).
  7. Has previously received natalizumab, efalizumab, adalimumab, AMG-181, anti-mucosal addressin cell adhesion molecule-1 antibodies, or rituximab.
  8. Has previously received vedolizumab.
  9. Has history or evidence of adenomatous colonic polyps that have not been removed, or colonic mucosal dysplasia.
  10. Evidence of an active infection during Screening.
  11. Evidence of, or treatment for, Clostridium difficile (C. difficile) or other intestinal pathogen within 28 days prior to the 1st dose of study drug.
  12. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection (* HBV immune participants, ie, being hepatitis B surface antigen [HBsAg], may participate).
  13. Has active or latent TB, regardless of treatment history.
  14. Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks of the administration of the 1st dose of study drug.
  15. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497469


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Locations
Layout table for location information
United States, Alabama
IMC - Diagnostic and Medical Clinic
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States, 85037
United States, Arkansas
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, United States, 72204
United States, California
WCCT Global (PH 1 Unit)
Costa Mesa, California, United States, 92626
California Medical Research Associates Inc.
Northridge, California, United States, 91324
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
United States, Colorado
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States, 80214-5434
United States, Connecticut
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
United States, Florida
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, United States, 33180
Advanced Clinical Research of Miami
Doral, Florida, United States, 33172
Wellness Clinical Research
Hialeah Gardens, Florida, United States, 33016
Nature Coast Clinical Research, LLC
Inverness, Florida, United States, 34452
Florida Center for Gastroenterology
Largo, Florida, United States, 33773-1615
South Florida Research Phase I-IV
Miami Springs, Florida, United States, 33166
Gastro Health
Miami, Florida, United States, 33143
Medical Professional Clinical Research
Miami, Florida, United States, 33165
Tellus Clinical Research, Inc.
Miami, Florida, United States, 33173
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
Internal Medicine Specialists
Orlando, Florida, United States, 32806
BRCR Medical Center, Inc.
Plantation, Florida, United States, 33322
Clinical Research Center of Florida
Pompano Beach, Florida, United States, 33060
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
Gastroenterology of Southern Associates
New Albany, Indiana, United States, 47150
United States, Iowa
Iowa Digestive Disease Center
Clive, Iowa, United States, 50325
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Research Concierge, LLC
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States, 70809
Lafayette General Medical Center
Lafayette, Louisiana, United States, 70503
Clinical Trials Management, LLC
Metairie, Louisiana, United States, 70006
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71103
United States, Maryland
Digestive Disease Associates
Catonsville, Maryland, United States, 21228
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
Center for Digestive Health and Nutritional Excellence
Troy, Michigan, United States, 48098
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States, 49519
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, Mississippi
Digestive Health Center PA
Ocean Springs, Mississippi, United States, 39564
United States, Missouri
Ehrhardt Clinical Research, LLC
Belton, Missouri, United States, 64012
Truman Medical Centers, Inc.
Kansas City, Missouri, United States, 64108
United States, Nebraska
Alegent Creighton Clinic Gastroenterology
Omaha, Nebraska, United States, 68124
United States, New Jersey
AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Mount Sinai - PRIME
Lake Success, New York, United States, 10029
Digestive Disease Care
New Hyde Park, New York, United States, 11040
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States, 12601
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7080
United States, Ohio
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States, 45219
Ohio State University Clinical Trials Management Office
Columbus, Ohio, United States, 43210
Dayton Gastroenterology, Inc
Dayton, Ohio, United States, 45415
Gastro-Enterology Research of Lima
Lima, Ohio, United States, 45806
United States, Oklahoma
Options Health Research
Tulsa, Oklahoma, United States, 74104
United States, Oregon
The Oregon Clinic-West Hills Gastroenterology
Portland, Oregon, United States, 97225
United States, Pennsylvania
Main Line Gastroenterology Associates
Malvern, Pennsylvania, United States, 19355
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Invocare Clinical Research Center
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-1375
United States, Texas
Texas Digestive Disease Consultants - Dallas
Dallas, Texas, United States, 75231
Baylor University Hospital
Dallas, Texas, United States, 75246
MedResearch, Inc
El Paso, Texas, United States, 79935
Gastroenterology Consultants of South Texas, PA
Harlingen, Texas, United States, 78550
Gulf Coast Research Group LLC
Houston, Texas, United States, 77098
Texas Digestive Disease Consultants - Irving
Irving, Texas, United States, 75039
Advanced Clinical Research Associates
Plano, Texas, United States, 75093
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultants - Southlake
Southlake, Texas, United States, 76092
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
United States, Washington
Virginia Mason Seattle Main Clinic
Seattle, Washington, United States, 98101
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States, 98801
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Allegiance Research Specialists, LLC
Milwaukee, Wisconsin, United States, 53226
Argentina
Instituto de Investigaciones Clinicas-Mar del Plata
Mar del Plata, Buenos Aires, Argentina, B7600FZ
Instituto Medico CER
Quilmes, Buenos Aires, Argentina, B1878DVB
Expertia S.A- Mautalen Salud e Investigacion
Ciudad Autonoma Buenos Aires, Argentina, C1128AAE
Centro de Investigaciones Clinicas Instituto del Corazon
Cordoba, Argentina, X5000EVQ
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Australia, Queensland
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Tennyson Centre Day Hospital
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Ballarat Base Hospital
Ballarat, Victoria, Australia, 3350
Monash Medical Centre Moorabbin
Clayton, Victoria, Australia, 3168
St Frances Xavier Cabrini Hospital
Malvern, Victoria, Australia, 3144
Belgium
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina, 78000
University Clinical Hospital Mostar
Mostar, Bosnia and Herzegovina, 88000
University Clinic Centre Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
Bulgaria
MHAT - Pazardzhik AD
Pazardzhik, Bulgaria, 4400
MHAT 'Avis Medica' OOD
Pleven, Bulgaria, 5800
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, Bulgaria, 5800
MHAT "Hadzhi Dimitar", OOD
Sliven, Bulgaria, 8800
"City Clinic UMHAC" EOOD
Sofia, Bulgaria, 1407
Medical Center "Excelsior", OOD
Sofia, Bulgaria, 1407
UMHAT "Sv. Ivan Rilski", EAD
Sofia, Bulgaria, 1431
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, Bulgaria, 1527
Fourth MHAT - Sofia EAD
Sofia, Bulgaria, 1606
Military Medical Academy - MHAT - Sofia
Sofia, Bulgaria, 1606
UMHAT 'Sveta Anna' AD
Sofia, Bulgaria, 1750
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, Bulgaria, 6000
MHAT 'Sv. Marina', EAD
Varna, Bulgaria, 9020
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2X8
Canada, Ontario
McMaster University Health Sciences Center
Hamilton, Ontario, Canada, L8N3Z5
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
LHSC - University Hospital
London, Ontario, Canada, N6A 5A5
LHSC - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, Colombia, 681004
Instituto de Coloproctologia ICO S.A.S.
Medellin, Colombia, 050025
Croatia
Clinical Hospital Centre Osijek
Osijek, Croatia, 31000
General Hospital Pula
Pula, Croatia, 52100
Polyclinic Medico
Rijeka, Croatia, 51000
Clinical Hospital Center "Sestre Milosrdnice"
Zagreb, Croatia, 10000
Clinical Hospital Centre Zagreb
Zagreb, Croatia, 10000
Clinical Hospital Dubrava
Zagreb, Croatia, 10000
Clinical Hospital Merkur
Zagreb, Croatia, 10000
Czechia
CCBR - Brno - CZ
Brno, Czechia, 60200
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia, 65691
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czechia, 500 12
CCBR Czech, a.s
Pardubice, Czechia, 530 02
A-Shine
Plzen, Czechia, 31200
CCBR - Prague - CZ
Praha 3, Czechia, 13000
Thomayerova nemocnice
Praha 4 - Krc, Czechia, 140 59
Klinicke centrum ISCARE Lighthouse
Praha 7, Czechia, 17004
Axon Clinical, s.r.o.
Praha 8, Czechia, 182 00
Denmark
Nordsjallands Hospital, Frederikssund
Frederikssund, Denmark, 3600
Hvidovre_Hospital
Hvidovre, Denmark, 2650
Koge Sygehus
Koge, Denmark, 4600
Odense Universitetshospital
Odense C, Denmark, 5000
Estonia
West Tallinn Central Hospital
Tallinn, Estonia, 10617
North Estonia Medical Centre Foundation
Tallinn, Estonia, 13419
Tartu University Hospital
Tartu, Estonia, 50406
France
CHU Nice - Hopital de l'Archet 2
Nice Cedex 3, Alpes Maritimes, France, 06200
Hopital Nord - CHU Marseille
Marseille cedex 20, Bouches-du-Rhone, France, 13915
Hopital Saint Joseph
Marseille, Bouches-du-Rhone, France, 13008
Groupe Hospitalier Sud - Hopital Haut-Leveque
Pessac, Gironde, France, 33604
CHU de Toulouse - Hopital Rangueil
Toulouse Cedex 09, Haute Garonne, France, 31059
Hopital Beaujon
Clichy cedex, Hauts De Seine, France, 92110
CHU Saint Etienne - Hopital Nord
Saint Etienne, Loire, France, 42055
Hopital de Brabois Adultes
Vandoeuvre les Nancy, Meurthe Et Moselle, France, 54511
Hopital Claude Huriez - CHU Lille
Lille cedex, Nord, France, 59037
CHU Amiens - Hopital Sud
Amiens Cedex, Somme, France, 80054
Centre Hospitalier Departemental Les Oudairies
La Roche S/ Yon Cedex 9, Vendee, France, 85925
Germany
Universitaetsklinikum Heidelberg
Heidelberg, Baden Wuerttemberg, Germany, 69120
Universitaetsklinikum Tuebingen
Tuebingen, Baden Wuerttemberg, Germany, 72076
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Hessen, Germany, 60590
Universitaetsklinikum Koeln
Koeln, Nordrhein Westfalen, Germany, 50937
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Rheinland Pfalz, Germany, 55131
Universitaetsklinikum Magdeburg A.oe.R
Magdeburg, Sachsen Anhalt, Germany, 39120
EUGASTRO GmbH
Leipzig, Sachsen, Germany, 04103
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig Holstein, Germany, 24105
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lubeck, Schleswig Holstein, Germany, 23538
Charite - Campus Virchow-Klinikum
Berlin, Germany, 13353
Krankenhaus Waldfriede e. V.
Berlin, Germany, 141 63
Asklepios Klinik Hamburg
Hamburg, Germany, 22559
Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
Tuen Mun Hospital
Medicine & Geriatrics, Hong Kong, 00000
The Chinese University of Hong Kong
Shatin, Hong Kong, 00000
Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Bekescsaba, Hungary, 5600
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
Budapest, Hungary, 1076
Semmelweis Egyetem
Budapest, Hungary, 1083
Semmelweis Egyetem
Budapest, Hungary, 1088
Pannonia Maganorvosi Centrum
Budapest, Hungary, 1136
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Hungary, 3300
Pecsi Tudomanyegyetem
Pecs, Hungary, 7624
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary, 6720
Tolna Megyei Balassa Janos Korhaz
Szekszard, Hungary, 7100
Israel
HaEmek Medical Center
Afula, Israel, 18101
Barzilai Medical Center
Ashkelon, Israel, 78278
Hillel Yaffe Medical
Hadera, Israel, 3810101
Wolfson Medical Center
Holon, Israel, 58100
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Clalit Health Services-Lev Talpiyot
Jerusalem, Israel, 9362410
Meir Medical Center
Kfar- Saba, Israel, 4428164
Galilee Medical Center
Nahariya, Israel, 22100
Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Kaplan Medical Center
Rechovot, Israel, 7610001
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
I.R.C.C.S Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138
Azienda Ospedaliera Ospedale Cannizzaro
Catania, Italy, 95100
Azienda Ospedaliero Universitaria San Martino
Genova, Italy, 16132
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, Italy, 98125
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milano, Italy, 20157
A.O.U. Policlinico di Modena
Modena, Italy, 41124
Azienda Ospedaliera Universitaria "Federico II"
Napoli, Italy, 80131
Seconda Universita degli Studi di Napoli
Napoli, Italy, 80131
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Azienda Ospedaliera Vincenzo Cervello
Palermo, Italy, 90146
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56124
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00152
Korea, Republic of
Hanyang Univerisy Guri Hospital
Guri-si, Gyeonggi-do, Korea, Republic of, 11923
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
The Catholic University of Korea, St. Vincent's Hospital
Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
Kyungpook National University Hospital
Daegu, Gyeongsangbuk-do, Korea, Republic of, 700-721
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Yeungnam University Hospital
Daegu, Korea, Republic of, 42415
Kyung Hee University Hospital
Seoul, Korea, Republic of, 02447
Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Severance Hospital, Yonsei University
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul, Korea, Republic of, 06591
Latvia
Digestive Diseases Center "Gastro"
Riga, Latvia, LV-1006
Pauls Stradins Clinical University Hospital SLLC
Riga, Latvia, LV1002
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania, 50009
Klaipeda Republican Hospital, Public Institution
Klaipeda, Lithuania, 92231
Klaipeda University Hospital, Public Institution
Klaipeda, Lithuania, 92288
Vilnius University Hospital Santariskiu Clinic, Public Institution
Vilnius, Lithuania, LT-08661
Mexico
Morales Vargas Centro de Investigacion, S.C.
Leon, Guanajuato, Mexico, 37000
Centro de Investigacion Farmacologica del Bajio, S.C.
Leon, Guanajuato, Mexico, 37520
Christus Muguerza Sur S.A. de C.V.
Monterrey, Nuevo Leon, Mexico, 64908
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, Mexico, 34000
Sociedad de Metabolismo y Corazon S.C
Veracruz, Mexico, 91910
Netherlands
Onze Lieve Vrouwe Gasthuis, Locatie Oost
Amsterdam, Netherlands, 1091 AC
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Universitair Medisch Centrum Groningen (UMCG)
Groningen, Netherlands, 9713 GZ
Maastricht University Medical Center
Maastricht, Netherlands, 6202 AZ
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 CE
Poland
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok, Poland, 15-275
NZOZ Vitamed
Bydgoszcz, Poland, 85-079
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
SP CSK im. prof. K. Gibinskiego SUM
Katowice, Poland, 40-752
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, Poland, 31-009
SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
Lodz, Poland, 90-153
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, Poland, 90-302
GASTROMED Sp. z o.o.
Lublin, Poland, 20-582
SOLUMED Centrum Medyczne
Poznan, Poland, 60-529
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, Poland, 71-434
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warszawa, Poland, 00-632
Centralny Szpital Kliniczny MSW w Warszawie
Warszawa, Poland, 02-507
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warszawa, Poland, 02-781
Nzoz Vivamed
Warszawa, Poland, 03-580
LexMedica Osrodek Badan Klinicznych
Wroclaw, Poland, 53-114
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
Wroclaw, Poland, 53-333
EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu
Wroclaw, Poland, 54-144
Portugal
Hospital de Braga
Braga, Portugal, 4710-243
Centro Hospitalar e Universitario de Coimbra E.P.E
Coimbra, Portugal, 3000-075
Centro Hospitalar Cova da Beira
Covilha, Portugal, 6200-502
Hospital da Senhora da Oliveira Guimaraes
Guimaraes, Portugal, 4835-044
Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE
Viana do Castelo, Portugal, 4904-858
Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E
Vila Nova de Gaia, Portugal, 4434-502
Romania
Spitalul Clinic Colentina
Bucuresti, Romania, 020125
Institutul Clinic Fundeni
Bucuresti, Romania, 022328
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timisoara, Romania, 300002
Russian Federation
SBEI HPE "Kazan State Medical University" of the MoH of the RF
Kazan, Russian Federation, 420012
TSBIH "Territorial Clinical Hospital"
Krasnoyarsk, Russian Federation, 660022
Research Institute of Gastroenterology
Moscow, Russian Federation, 111123
FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
Moscow, Russian Federation, 119333
FSBI State Scientific Centre of Coloproctology" of the MoH of RF
Moscow, Russian Federation, 123154
SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
Nizhny Novgorod, Russian Federation, 603126
SBEIHPE Novosibirsk State Medical University
Novosibirsk, Russian Federation, 630091
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
Novosibirsk, Russian Federation, 630117
BHI of Omsk region Clinical Oncology Dispensary
Omsk, Russian Federation, 644013
SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF
Omsk, Russian Federation, 644099
SBEI HPE "Rostov State Medical University" of the MoH of the RF
Rostov-on-Don, Russian Federation, 344022
FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
Saint-Petersburg, Russian Federation, 194044
SPb SBIH "City Hospital # 26"
Saint-Petersburg, Russian Federation, 196247
SPb SBIH "City Hospital # 9"
Saint-Petersburg, Russian Federation, 197110
Private Educational Institution of Higher Education "Medical University "REAVIZ"
Samara, Russian Federation, 443115
SIH "Regional Clinical Hospital "
Saratov, Russian Federation, 410053
SPb SBIH "City Hospital # 40 of Kurortnyi region"
Sestroretsk, Russian Federation, 197706
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk, Russian Federation, 214019
SPb SBIH "City Hospital of Saint Martyr Elizaveta"
St. Petersburg, Russian Federation, 195257
SBIH of Yaroslavl region " Regional Clinical Hospital "
Yaroslavl, Russian Federation, 150062
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Center Zvezdara
Belgrade, Serbia, 11000
Clinical Center Bezanijska kosa
Belgrade, Serbia, 11080
Clinical Center Zemun
Belgrade, Serbia, 11080
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Clinical Center Nis
Nis, Serbia, 18000
Clinical Center of Vojvodina
Novi Sad, Serbia, 21000
Slovakia
IBDcentrum s.r.o.
Bratislava, Slovakia, 81108
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, Slovakia, 82606
Gastroped s.r.o.
Kosice, Slovakia, 04001
KM Management spol. s r.o.
Nitra, Slovakia, 949 01
Gastro I, s.r.o.
Presov, Slovakia, 080 01
Frantisek Horvath- GEA
Sahy, Slovakia, 936 01
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
National Taiwan University Hospital
Taipei, Taiwan, 100
Mackay Memorial Hospital
Taipei, Taiwan, 10449
Turkey
Ankara University Medical Faculty
Ankara, Turkey, 06100
Acibadem Fulya Hospital
Istanbul, Turkey, 34349
Haydarpasa Numune Training and Research Hospital
Istanbul, Turkey, 34668
Marmara University Pendik Research and Training Hospital
Istanbul, Turkey, 34899
Kocaeli Derince Training and Research Hospital
Kocaeli, Turkey, 41380
Mersin University Medical Faculty
Mersin, Turkey, 33343
Ukraine
RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
Chernivtsi, Ukraine, 58002
SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
Dnipropetrovsk, Ukraine, 49074
Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, Ukraine, 76008
CI of PH Kharkiv CCH #2
Kharkiv, Ukraine, 61037
CI A.and O. Tropiny City Clinical Hospital
Kherson, Ukraine, 73000
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
Kirovohrad, Ukraine, 25006
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, Ukraine, 01023
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
Kyiv, Ukraine, 01023
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
Kyiv, Ukraine, 01103
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
Kyiv, Ukraine, 04201
CI of TRC Ternopil University Hospital
Lviv, Ukraine, 46002
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv, Ukraine, 79059
CI Odesa Regional Clinical Hospital
Odesa, Ukraine, 65025
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
Uzhgorod, Ukraine, 88009
Private Small Enterprise Medical Center Pulse
Vinnytsia, Ukraine, 21001
Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, Ukraine, 21005
MCIC MC LLC Health Clinic
Vinnytsia, Ukraine, 21029
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU
Vinnytsia, Ukraine, 21029
CI City Clinical Hospital #6 Dept of Gastroenterology
Zaporizhzhia, Ukraine, 69035
SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
Zaporizhzhia, Ukraine, 69104
United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom, PL6 5FP
Salford Royal
Salford, Greater Manchester, United Kingdom, M6 8HD
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR47UY
Glasgow Royal Infirmary
Glasgow, Strathclyde, United Kingdom, G4 0SF
University Hospital Coventry
Coventry, West Midlands, United Kingdom, CV2 2DX
Royal Wolverhampton hospital
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] February 26, 2014
Statistical Analysis Plan  [PDF] October 18, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02497469     History of Changes
Other Study ID Numbers: MLN0002-3026
U1111-1168-6713 ( Registry Identifier: WHO )
2015-000939-33 ( EudraCT Number )
NL54690.056.15 ( Registry Identifier: CCMO )
First Posted: July 14, 2015    Key Record Dates
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Vedolizumab
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents