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

NCT ID: NCT02497469

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 771 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-29
• Study Completion Date: 2019-01-18

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.

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.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vedolizumab

Intervention Type: DRUG

Vedolizumab infusion

Adalimumab placebo

Intervention Type: DRUG

Adalimumab placebo-matching injection

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.

Group Type: ACTIVE_COMPARATOR

Adalimumab

Intervention Type: DRUG

Adalimumab injection

Vedolizumab placebo

Intervention Type: DRUG

Vedolizumab placebo-matching infusion

Interventions

Vedolizumab

Vedolizumab infusion

Intervention Type: DRUG

Adalimumab placebo

Adalimumab placebo-matching injection

Intervention Type: DRUG

Adalimumab

Adalimumab injection

Intervention Type: DRUG

Vedolizumab placebo

Vedolizumab placebo-matching infusion

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

IMC - Diagnostic and Medical Clinic

Mobile, Alabama, United States

Arizona Arthritis & Rheumatology Research, PLLC

Phoenix, Arizona, United States

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, United States

WCCT Global (PH 1 Unit)

Costa Mesa, California, United States

California Medical Research Associates Inc.

Northridge, California, United States

Sutter Institute for Medical Research

Sacramento, California, United States

Rocky Mountain Gastroenterology

Lakewood, Colorado, United States

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Innovative Medical Research of South Florida, Inc.

Aventura, Florida, United States

Advanced Clinical Research of Miami

Doral, Florida, United States

Wellness Clinical Research

Hialeah Gardens, Florida, United States

Nature Coast Clinical Research, LLC

Inverness, Florida, United States

Florida Center for Gastroenterology

Largo, Florida, United States

Gastro Health

Miami, Florida, United States

Medical Professional Clinical Research

Miami, Florida, United States

Tellus Clinical Research, Inc.

Miami, Florida, United States

South Florida Research Phase I-IV

Miami Springs, Florida, United States

Gastroenterology Group of Naples

Naples, Florida, United States

Internal Medicine Specialists

Orlando, Florida, United States

BRCR Medical Center, Inc.

Plantation, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

Shafran Gastroenterology Center

Winter Park, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Gastroenterology Associates of Central Georgia

Macon, Georgia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

Gastroenterology of Southern Associates

New Albany, Indiana, United States

Iowa Digestive Disease Center

Clive, Iowa, United States

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

Research Concierge, LLC

Owensboro, Kentucky, United States

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, United States

Lafayette General Medical Center

Lafayette, Louisiana, United States

Clinical Trials Management, LLC

Metairie, Louisiana, United States

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Digestive Disease Associates

Catonsville, Maryland, United States

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Center for Digestive Health and Nutritional Excellence

Troy, Michigan, United States

Gastroenterology Associates of Western Michigan, P.L.C.

Wyoming, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Digestive Health Center PA

Ocean Springs, Mississippi, United States

Ehrhardt Clinical Research, LLC

Belton, Missouri, United States

Truman Medical Centers, Inc.

Kansas City, Missouri, United States

Alegent Creighton Clinic Gastroenterology

Omaha, Nebraska, United States

AGA Clinical Research Associates, LLC

Egg Harbor, New Jersey, United States

Long Island Clinical Research Associates

Great Neck, New York, United States

Mount Sinai - PRIME

Lake Success, New York, United States

Digestive Disease Care

New Hyde Park, New York, United States

Premier Medical Group of the Hudson Valley, PC

Poughkeepsie, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Consultants for Clinical Research Inc.

Cincinnati, Ohio, United States

Ohio State University Clinical Trials Management Office

Columbus, Ohio, United States

Dayton Gastroenterology, Inc

Dayton, Ohio, United States

Gastro-Enterology Research of Lima

Lima, Ohio, United States

Options Health Research

Tulsa, Oklahoma, United States

The Oregon Clinic-West Hills Gastroenterology

Portland, Oregon, United States

Main Line Gastroenterology Associates

Malvern, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Invocare Clinical Research Center

West Columbia, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, United States

Baylor University Hospital

Dallas, Texas, United States

MedResearch, Inc

El Paso, Texas, United States

Gastroenterology Consultants of South Texas, PA

Harlingen, Texas, United States

Gulf Coast Research Group LLC

Houston, Texas, United States

Texas Digestive Disease Consultants - Irving

Irving, Texas, United States

Advanced Clinical Research Associates

Plano, Texas, United States

Gastroenterology Research of San Antonio, LLC

San Antonio, Texas, United States

Texas Digestive Disease Consultants - Southlake

Southlake, Texas, United States

Digestive Health Specialists of Tyler

Tyler, Texas, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Virginia Mason Seattle Main Clinic

Seattle, Washington, United States

Wenatchee Valley Hospital & Clinics

Wenatchee, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

Allegiance Research Specialists, LLC

Milwaukee, Wisconsin, United States

Instituto de Investigaciones Clinicas-Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto Medico CER

Quilmes, Buenos Aires, Argentina

Expertia S.A- Mautalen Salud e Investigacion

Ciudad Autonoma Buenos Aires, , Argentina

Centro de Investigaciones Clinicas Instituto del Corazon

Córdoba, , Argentina

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Mater Adult Hospital

South Brisbane, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Tennyson Centre Day Hospital

Bedford Park, South Australia, Australia

Ballarat Base Hospital

Ballarat, Victoria, Australia

Monash Medical Centre Moorabbin

Clayton, Victoria, Australia

St Frances Xavier Cabrini Hospital

Malvern, Victoria, Australia

Universitair Ziekenhuis Gent

Ghent, , Belgium

University Clinical Centre of the Republic of Srpska

Banja Luka, , Bosnia and Herzegovina

University Clinical Hospital Mostar

Mostar, , Bosnia and Herzegovina

University Clinic Centre Sarajevo

Sarajevo, , Bosnia and Herzegovina

MHAT - Pazardzhik AD

Pazardzhik, , Bulgaria

MHAT 'Avis Medica' OOD

Pleven, , Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

MHAT "Hadzhi Dimitar", OOD

Sliven, , Bulgaria

"City Clinic UMHAC" EOOD

Sofia, , Bulgaria

Medical Center "Excelsior", OOD

Sofia, , Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, , Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

Sofia, , Bulgaria

Fourth MHAT - Sofia EAD

Sofia, , Bulgaria

Military Medical Academy - MHAT - Sofia

Sofia, , Bulgaria

UMHAT 'Sveta Anna' AD

Sofia, , Bulgaria

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

Stara Zagora, , Bulgaria

MHAT 'Sv. Marina', EAD

Varna, , Bulgaria

University of Alberta

Edmonton, Alberta, Canada

McMaster University Health Sciences Center

Hamilton, Ontario, Canada

Hotel Dieu Hospital

Kingston, Ontario, Canada

LHSC - University Hospital

London, Ontario, Canada

LHSC - Victoria Hospital

London, Ontario, Canada

Toronto Digestive Disease Associates, Inc.

Vaughan, Ontario, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, , Colombia

Instituto de Coloproctologia ICO S.A.S.

Medellín, , Colombia

Clinical Hospital Centre Osijek

Osijek, , Croatia

General Hospital Pula

Pula, , Croatia

Polyclinic Medico

Rijeka, , Croatia

Clinical Hospital Center "Sestre Milosrdnice"

Zagreb, , Croatia

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Clinical Hospital Dubrava

Zagreb, , Croatia

Clinical Hospital Merkur

Zagreb, , Croatia

CCBR - Brno - CZ

Brno, , Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, , Czechia

CCBR Czech, a.s

Pardubice, , Czechia

A-Shine

Pilsen, , Czechia

CCBR - Prague - CZ

Prague, , Czechia

Klinicke centrum ISCARE Lighthouse

Prague, , Czechia

Axon Clinical, s.r.o.

Prague, , Czechia

Thomayerova nemocnice

Praha 4 - Krc, , Czechia

Nordsjallands Hospital, Frederikssund

Frederikssund, , Denmark

Hvidovre_Hospital

Hvidovre, , Denmark

Koge Sygehus

Køge, , Denmark

Odense Universitetshospital

Odense C, , Denmark

West Tallinn Central Hospital

Tallinn, , Estonia

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

CHU Nice - Hopital de l'Archet 2

Nice, Alpes Maritimes, France

Hopital Saint Joseph

Marseille, Bouches-du-Rhone, France

Hopital Nord - CHU Marseille

Marseille, Bouches-du-Rhone, France

Groupe Hospitalier Sud - Hopital Haut-Leveque

Pessac, Gironde, France

CHU de Toulouse - Hopital Rangueil

Toulouse, Haute Garonne, France

Hopital Beaujon

Clichy, Hauts De Seine, France

Hopital de Brabois Adultes

Vandœuvre-lès-Nancy, Meurthe Et Moselle, France

Hopital Claude Huriez - CHU Lille

Lille, Nord, France

CHU Saint Etienne - Hopital Nord

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

CHU Amiens - Hopital Sud

Amiens, Somme, France

Centre Hospitalier Departemental Les Oudairies

La Roche S/ Yon Cedex 9, Vendee, France

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt am Main, Hesse, Germany

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, Rhineland-Palatinate, Germany

EUGASTRO GmbH

Leipzig, Saxony, Germany

Universitaetsklinikum Magdeburg A.oe.R

Magdeburg, Saxony-Anhalt, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig-Holstein, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, Schleswig-Holstein, Germany

Charite - Campus Virchow-Klinikum

Berlin, , Germany

Krankenhaus Waldfriede e. V.

Berlin, , Germany

Asklepios Klinik Hamburg

Hamburg, , Germany

The University of Hong Kong

Hong Kong, , Hong Kong

Tuen Mun Hospital

Medicine & Geriatrics, , Hong Kong

The Chinese University of Hong Kong

Shatin, , Hong Kong

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

Békéscsaba, , Hungary

Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Pannonia Maganorvosi Centrum

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, , Hungary

Pecsi Tudomanyegyetem

Pécs, , Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Tolna Megyei Balassa Janos Korhaz

Szekszárd, , Hungary

HaEmek Medical Center

Afula, , Israel

Barzilai Medical Center

Ashkelon, , Israel

Hillel Yaffe Medical

Hadera, , Israel

Wolfson Medical Center

Holon, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Clalit Health Services-Lev Talpiyot

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Galilee Medical Center

Nahariya, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Istituto Clinico Humanitas

Rozzano, Milano, Italy

I.R.C.C.S Policlinico San Donato

San Donato Milanese, Milano, Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, , Italy

Azienda Ospedaliera Ospedale Cannizzaro

Catania, , Italy

Azienda Ospedaliero Universitaria San Martino

Genova, , Italy

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, , Italy

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Milan, , Italy

A.O.U. Policlinico di Modena

Modena, , Italy

Azienda Ospedaliera Universitaria "Federico II"

Napoli, , Italy

Seconda Universita degli Studi di Napoli

Napoli, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

Azienda Ospedaliera Vincenzo Cervello

Palermo, , Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, , Italy

Digestive Diseases Center "Gastro"

Riga, , Latvia

Pauls Stradins Clinical University Hospital SLLC

Riga, , Latvia

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Klaipeda Republican Hospital, Public Institution

Klaipėda, , Lithuania

Klaipeda University Hospital, Public Institution

Klaipėda, , Lithuania

Vilnius University Hospital Santariskiu Clinic, Public Institution

Vilnius, , Lithuania

Morales Vargas Centro de Investigacion, S.C.

León, Guanajuato, Mexico

Centro de Investigacion Farmacologica del Bajio, S.C.

León, Guanajuato, Mexico

Christus Muguerza Sur S.A. de C.V.

Monterrey, Nuevo León, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, , Mexico

Sociedad de Metabolismo y Corazon S.C

Veracruz, , Mexico

Onze Lieve Vrouwe Gasthuis, Locatie Oost

Amsterdam, , Netherlands

Academisch Medisch Centrum

Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen (UMCG)

Groningen, , Netherlands

Maastricht University Medical Center

Maastricht, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

Bialystok, , Poland

NZOZ Vitamed

Bydgoszcz, , Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

SP CSK im. prof. K. Gibinskiego SUM

Katowice, , Poland

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, , Poland

SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM

Lodz, , Poland

Santa Familia Centrum Badan, Profilaktyki i Leczenia

Lodz, , Poland

GASTROMED Sp. z o.o.

Lublin, , Poland

SOLUMED Centrum Medyczne

Poznan, , Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, , Poland

Centrum Zdrowia Matki, Dziecka i Mlodziezy

Warsaw, , Poland

Centralny Szpital Kliniczny MSW w Warszawie

Warsaw, , Poland

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

Warsaw, , Poland

Nzoz Vivamed

Warsaw, , Poland

LexMedica Osrodek Badan Klinicznych

Wroclaw, , Poland

Ars-Medica S.C Rybak Maria, Rybak Zbigniew

Wroclaw, , Poland

EuroMediCare Szpital Specjalistyczny z Przychodni we Wroclawiu

Wroclaw, , Poland

Hospital de Braga

Braga, , Portugal

Centro Hospitalar e Universitario de Coimbra E.P.E

Coimbra, , Portugal

Centro Hospitalar Cova da Beira

Covilha, , Portugal

Hospital da Senhora da Oliveira Guimaraes

Guimarães, , Portugal

Centro Hospitalar do Alto Minho - Unidade Local de Saude do Alto Minho, EPE

Viana do Castelo, , Portugal

Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

Vila Nova de Gaia, , Portugal

Spitalul Clinic Colentina

Bucharest, , Romania

Institutul Clinic Fundeni

Bucharest, , Romania

S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

Timișoara, , Romania

SBEI HPE "Kazan State Medical University" of the MoH of the RF

Kazan', , Russia

TSBIH "Territorial Clinical Hospital"

Krasnoyarsk, , Russia

Research Institute of Gastroenterology

Moscow, , Russia

FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

Moscow, , Russia

FSBI State Scientific Centre of Coloproctology" of the MoH of RF

Moscow, , Russia

SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

Nizhny Novgorod, , Russia

SBEIHPE Novosibirsk State Medical University

Novosibirsk, , Russia

FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

Novosibirsk, , Russia

BHI of Omsk region Clinical Oncology Dispensary

Omsk, , Russia

SBEI of HPE "Omsk SMA" SBEI HPE "Omsk State Medical University" of the MoH of the RF

Omsk, , Russia

SBEI HPE "Rostov State Medical University" of the MoH of the RF

Rostov-on-Don, , Russia

FSMEI HPE Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia

Saint Petersburg, , Russia

SPb SBIH "City Hospital of Saint Martyr Elizaveta"

Saint Petersburg, , Russia

SPb SBIH "City Hospital # 26"

Saint Petersburg, , Russia

SPb SBIH "City Hospital # 9"

Saint Petersburg, , Russia

Private Educational Institution of Higher Education "Medical University "REAVIZ"

Samara, , Russia

SIH "Regional Clinical Hospital "

Saratov, , Russia

SPb SBIH "City Hospital # 40 of Kurortnyi region"

Sestroretsk, , Russia

RSBIH "Smolensk Regional Clinical Hospital"

Smolensk, , Russia

SBIH of Yaroslavl region " Regional Clinical Hospital "

Yaroslavl, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Center Zvezdara

Belgrade, , Serbia

Clinical Center Bezanijska kosa

Belgrade, , Serbia

Clinical Center Zemun

Belgrade, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Center Nis

Niš, , Serbia

Clinical Center of Vojvodina

Novi Sad, , Serbia

IBDcentrum s.r.o.

Bratislava, , Slovakia

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava, , Slovakia

Gastroped s.r.o.

Košice, , Slovakia

KM Management spol. s r.o.

Nitra, , Slovakia

Gastro I, s.r.o.

Prešov, , Slovakia

Frantisek Horvath- GEA

Šahy, , Slovakia

Hanyang Univerisy Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Kyungpook National University Hospital

Daegu, Gyeongsangbuk-do, South Korea

Pusan National University Hospital

Busan, , South Korea

Yeungnam University Hospital

Daegu, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

The Catholic University of Korea, Seoul St. Marys Hospital

Seoul, , South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Acibadem Fulya Hospital

Istanbul, , Turkey (Türkiye)

Haydarpasa Numune Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Marmara University Pendik Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Kocaeli Derince Training and Research Hospital

Kocaeli, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

Chernivtsi, , Ukraine

SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU

Dnipropetrovsk, , Ukraine

Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU

Ivano-Frankivsk, , Ukraine

CI of PH Kharkiv CCH #2

Kharkiv, , Ukraine

CI A.and O. Tropiny City Clinical Hospital

Kherson, , Ukraine

Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

Kirovohrad, , Ukraine

CI of Kyiv RC Kyiv Regional Clinical Hospital

Kyiv, , Ukraine

MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

Kyiv, , Ukraine

Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

Kyiv, , Ukraine

Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE

Kyiv, , Ukraine

CI of TRC Ternopil University Hospital

Lviv, , Ukraine

Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

Lviv, , Ukraine

CI Odesa Regional Clinical Hospital

Odesa, , Ukraine

SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU

Uzhhorod, , Ukraine

Private Small Enterprise Medical Center Pulse

Vinnytsia, , Ukraine

Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU

Vinnytsia, , Ukraine

MCIC MC LLC Health Clinic

Vinnytsia, , Ukraine

SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

Vinnytsia, , Ukraine

CI City Clinical Hospital #6 Dept of Gastroenterology

Zaporizhzhia, , Ukraine

SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU

Zaporizhzhia, , Ukraine

Derriford Hospital

Plymouth, Devon, United Kingdom

Salford Royal

Salford, Greater Manchester, United Kingdom

Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom

Glasgow Royal Infirmary

Glasgow, Strathclyde, United Kingdom

University Hospital Coventry

Coventry, West Midlands, United Kingdom

Royal Wolverhampton hospital

Wolverhampton, West Midlands, United Kingdom

Countries

United States; Argentina; Australia; Belgium; Bosnia and Herzegovina; Bulgaria; Canada; Colombia; Croatia; Czechia; Denmark; Estonia; France; Germany; Hong Kong; Hungary; Israel; Italy; Latvia; Lithuania; Mexico; Netherlands; Poland; Portugal; Romania; Russia; Serbia; Slovakia; South Korea; Spain; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.

Reference Type: DERIVED

PMID: 35934286 (View on PubMed)

Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Danese S, Rogers R, Bornstein JD, Chen J, Schreiber S, Sands BE, Lirio RA. Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY). Gastroenterology. 2021 Oct;161(4):1156-1167.e3. doi: 10.1053/j.gastro.2021.06.015. Epub 2021 Jun 16.

Reference Type: DERIVED

PMID: 34144047 (View on PubMed)

Sands BE, Peyrin-Biroulet L, Loftus EV Jr, Danese S, Colombel JF, Toruner M, Jonaitis L, Abhyankar B, Chen J, Rogers R, Lirio RA, Bornstein JD, Schreiber S; VARSITY Study Group. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226. doi: 10.1056/NEJMoa1905725.

Reference Type: DERIVED

PMID: 31553834 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1168-6713

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-000939-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL54690.056.15

Identifier Type: REGISTRY

Identifier Source: secondary_id

MLN0002-3026

Identifier Type: -

Identifier Source: org_study_id