Clinical trial NCT02435992: Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 1012
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

Detailed description: The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

Eligibility criteria: Inclusion Criteria:

* Aged 18 to 75 years (at screening for Cohort 1 and 2)
* UC confirmed on endoscopy
* Moderately to severely active UC (May score 6-12)
* Currently receiving treatment with aminosalisylate, prednisone, or budesonide
* Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Exclusion Criteria:

* Have severe extensive colitis as evidence by:
* Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
* Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
* Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
* Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
* History of uveitis or unknown macular edema
* Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

Primary outcomes:
measure: Percentage of Participants in Clinical Remission at 10 Weeks
timeFrame: At 10 Weeks
measure: Percentage of Participants in Clinical Remission at 52 Weeks
timeFrame: At 52 Weeks
Secondary outcomes:
measure: Percentage of Participants With Clinical Response at 10 Weeks
timeFrame: At 10 Weeks
measure: Percentage of Participants With Endoscopic Improvement at 10 Weeks
timeFrame: At 10 Weeks
measure: Percentage of Participants With Mucosal Healing at 10 Weeks
timeFrame: At 10 Weeks
measure: Percentage of Participants in Clinical Response at 52 Weeks
timeFrame: At 52 Weeks
measure: Percentage of Participants With Endoscopic Improvement at 52 Weeks
timeFrame: At 52 Weeks
measure: Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10
timeFrame: At 52 Weeks
measure: Percentage of Participants With Corticosteroid Free Remission at 52 Weeks
timeFrame: At 52 Weeks
measure: Percentage of Participants With Mucosal Healing at 52 Weeks
timeFrame: At 52 Weeks
measure: Percentage of Participants With Durable Clinical Remission at 52 Weeks
timeFrame: At 52 Weeks
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Arizona Digestive Health
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research LLC
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology, P.A.
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Costa Mesa
country: United States
facility: Aurora Care Clinic
state: California
city: Garden Grove
country: United States
facility: Valley View Internal Medicine
state: California
city: Huntington Beach
country: United States
facility: Davita Clinical Trials, LLC
state: California
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: Lancaster
country: United States
facility: OM Research
state: California
city: Los Angeles
country: United States
facility: University of Southern California - Keck School of Medicine
state: California
city: Los Angeles
country: United States
facility: Southern California Research Institute Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: Gastrointestinal Biosciences
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation (Parent)
state: California
city: Oceanside
country: United States
facility: Alliance Clinical Research, LLC
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco (PARENT)
state: California
city: Hamden
country: United States
facility: Medical Research Center of Connecticut, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida Inc - Clearwater
state: Florida
city: Delray Beach
country: United States
facility: Advanced Pharma Research, Inc
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Doral
country: United States
facility: Dolphin Medical Research
state: Florida
city: Hialeah
country: United States
facility: South Florida Clinical Trials
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: Miami
country: United States
facility: City Medical Group
state: Florida
city: Miami
country: United States
facility: Advanced Clincial Research
state: Florida
city: Miami
country: United States
facility: Advanced Clinical Research of Miami
state: Florida
city: Miami
country: United States
facility: Regenerate Clinical Trials
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: New Smyrna Beach
country: United States
facility: NSB Research
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research
state: Florida
city: North Miami Beach
country: United States
facility: Med-Care Research
state: Florida
city: Orlando
country: United States
facility: Center For Digestive Health
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research, Corp
state: Florida
city: Pinellas Park
country: United States
facility: Theia Clinical Research, LLC
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates LLC
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLLC
state: Idaho
city: Chicago
country: United States
facility: Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: DM Clinical Research
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Group
state: Maryland
city: Baltimore
country: United States
facility: Woodholme Gastroenterology
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Clinical Research Network
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Towson
country: United States
facility: Charm City Research Group
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Brockton
country: United States
facility: Commonwealth Clinical Studies, PLLC.
state: Massachusetts
city: Marlborough
country: United States
facility: Community Clinical Research Network
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Troy
country: United States
facility: Center For Digestive Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Belton
country: United States
facility: Ehrhardt Clinical Research, LLC
state: Missouri
city: Bridgeton
country: United States
facility: Clinical Research Professionals, LLC - De Paul Medical Dr
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Research Professionals LLC - The Pines Court
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Research Professionals, LLC - Olde Cabin Rd
state: Missouri
city: Springfield
country: United States
facility: Mercy Research
state: Missouri
city: Lebanon
country: United States
facility: Mary Hitchcock Memorial Hospital
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: NY Scientific
state: New York
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Icahn School of Medicine Mount Sinai Beth Isreal
state: New York
city: New York
country: United States
facility: Concord Medical Group PRIME
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Mount Sinai - PRIME
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, P.A.
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas HealthCare System Digestive Health
state: North Carolina
city: Jacksonville
country: United States
facility: East Carolina Gastroenterology, PA
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialists, PA
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health Clinical Trials Office
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Clinical Trials Management Office
state: Ohio
city: Springfield
country: United States
facility: Clinical Inquest Center Ltd
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Columbia
country: United States
facility: Consultants in Gastroenterology, PA
state: South Carolina
city: Orangeburg
country: United States
facility: Gastroenterology Associates of Orangeburg
state: South Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke-Army Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Houston
country: United States
facility: Gulf Coast Research Group LLC
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Houston
country: United States
facility: Houston Endoscopy and Research Center
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio, LLC
state: Texas
city: San Antonio
country: United States
facility: San Antonio Gastroenterology
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake
state: Texas
city: Spring
country: United States
facility: Spring Gastroenterology
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Virginia Beach
country: United States
facility: Gastroenterology, LTD
state: Virginia
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
city: Cordoba
country: Argentina
facility: Instituto DAMIC Fundacion Rusculleda
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Quilmes
country: Argentina
facility: Instituto Medico CER
city: Rosario
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos
city: Five Dock
country: Australia
facility: Centre For Digestive Diseases
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Malvern
country: Australia
facility: Cabrini Hospital Malvern
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Bentleigh East
country: Australia
facility: Monash Medical Centre Clayton
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Vienna
country: Austria
facility: Medical University Vienna
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Hospital
city: Minsk
country: Belarus
facility: City Clinical Hospital No 10
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHC - Clinique St-Jospeh
city: Dupnitsa
country: Bulgaria
facility: Medical Centre "Asklepii", OOD
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Kaspela", EOOD
city: Ruse
country: Bulgaria
facility: MC Rusemed ltd.
city: Sofia
country: Bulgaria
facility: NMTH "Tsar Boris III"
city: Sofia
country: Bulgaria
facility: MHAT "Lyulin", EAD
city: Sofia
country: Bulgaria
facility: City Clinic UMHAC EOOD
city: Sofia
country: Bulgaria
facility: MHAT 'Tokuda Hospital Sofia', EAD
city: Sofia
country: Bulgaria
facility: UMHAT 'Tsaritsa Yoanna - ISUL', EAD
city: Sofia
country: Bulgaria
facility: Fourth MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: UMHAT 'Sveta Anna' AD
city: Sofia
country: Bulgaria
facility: UMHAT "SofiaMed", OOD
city: Stara Zagora
country: Bulgaria
facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
city: Varna
country: Bulgaria
facility: MHAT 'Sv. Marina', EAD
city: Veliko Tarnovo
country: Bulgaria
facility: MC Medica Plus
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Brandon
country: Canada
facility: Brandon Medical Arts Clinic
state: Manitoba
city: Lindsay
country: Canada
facility: Viable Clinical Research - Lindsay
state: Ontario
city: London
country: Canada
facility: LHSC - University Hospital
state: Ontario
city: London
country: Canada
facility: LHSC - Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc.
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne
state: Quebec
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hôpital Fleurimont
state: Quebec
city: Osijek
country: Croatia
facility: Clinical Hospital Center Osijek
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka
city: Zagreb
country: Croatia
facility: Clinical Hospital "Sveti Duh", Clinic of Internal Diseases
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Klatovy
country: Czechia
facility: GASTRO JeKa s.r.o.
city: Olomouc
country: Czechia
facility: Gregar s.r.o.
city: Olomouc
country: Czechia
facility: PreventaMed
city: Prague 9
country: Czechia
facility: ISCARE, a.s.
city: Praha 4
country: Czechia
facility: Institut klinicke a experimentalni mediciny
city: Praha 4
country: Czechia
facility: Thomayerova nemocnice
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Tbilisi
country: Georgia
facility: LTD Research Institute of Clinical Medicine
city: Tbilisi
country: Georgia
facility: LLC Vivamedi
city: Tbilisi
country: Georgia
facility: LTD Academician N.Kipshidze Central University Clinic
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
city: Tbilisi
country: Georgia
facility: LTD Coloproctological Center
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charite - Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend
city: Dachau
country: Germany
facility: Medical Care Unit Dachau
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitaet
city: Frankfurt
country: Germany
facility: Crohn Colitis Centrum Rhein Main
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Larissa Thessaly
country: Greece
facility: University General Hospital of Larissa
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Hippokration
city: Thessaloniki
country: Greece
facility: 424th Army General Hospital
city: Balatonfured
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Budapest
country: Hungary
facility: Szent Margit Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
city: Kaposvar
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz
city: Letavertes
country: Hungary
facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
city: Mohacs
country: Hungary
facility: Mohacsi Korhaz
city: Nyiregyhaza
country: Hungary
facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Genova
country: Italy
facility: Azienda Ospedaliero Universitaria San Martino
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Complesso Integrato Columbus
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: San Giovanni Rotondo FG
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Guri-si
country: Korea, Republic of
facility: Hanyang Univerisy Guri Hospital
city: Seongnam-si,
country: Korea, Republic of
facility: CHA Bundang Medical Center CHA University
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St.Vicent's Hospital
city: Wonju-Si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Chisinau
country: Moldova, Republic of
facility: "Sfanta Treime" Clinical Municipal Hospital
city: Chisinau
country: Moldova, Republic of
facility: Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery
city: Chisinau
country: Moldova, Republic of
facility: "Sf. Arhanghel Mihail" Municipal Clinical Hospital
city: Chisinau
country: Moldova, Republic of
facility: Republican Clinical Hospital
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum (VUMC)
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen (UMCG)
city: Maastrich
country: Netherlands
facility: Maastricht University Medical Center
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard-Geleen
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
city: Christchurch
country: New Zealand
facility: Christchurch Hospital NZ
city: Dunedin
country: New Zealand
facility: Dunedin Public Hospital
city: Bydgoszcz
country: Poland
facility: Clinsante S.C. Osrodek Badan Klinicznych
city: Chorzow
country: Poland
facility: Specjalistyczna Przychodnia Lekarska Medicus
city: Klodzko
country: Poland
facility: GLOBE Clinical Research Sp. z o.o. LLC
city: Krakow
country: Poland
facility: PLEJADY Sp. z o.o. (LLC) Medical Centre
city: Kraków
country: Poland
facility: Centrum Medyczne A-Z Clinic
city: Ksawerow
country: Poland
facility: Healthcare Center Orkan Med Stec Michalska Spolka Jawna
city: Lodz
country: Poland
facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin II
city: Piotrkow Trybunalski
country: Poland
facility: Trialmed Llc
city: Poznan
country: Poland
facility: SOLUMED Centrum Medyczne
city: Sopot
country: Poland
facility: Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
city: Staszow
country: Poland
facility: KO-MED Centra Kliniczne Staszow
city: Torun
country: Poland
facility: GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe
city: Warsaw
country: Poland
facility: MDM Healthcare Centre
city: Warsaw
country: Poland
facility: Nzoz Vivamed
city: Wierzchoslawice
country: Poland
facility: Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice
city: Wroclaw
country: Poland
facility: LexMedica Osrodek Badan Klinicznych
city: Bacau
country: Romania
facility: Bacau County Emergency Hospital, Department of Gastroenterology
city: Bucharest
country: Romania
facility: Hyperclinica MedLife Grivita
city: Bucharest
country: Romania
facility: Bucharest University Emergency Hospital, Department of Internal Medicine II
city: Cluj-Napoca
country: Romania
facility: TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy
city: Constanta
country: Romania
facility: Sf. Apostol Andrei Constanta Emergency Clinical County Hospital
city: Craiova
country: Romania
facility: Craiova County Emergency Clinical Hospital
city: Timisoara
country: Romania
facility: "Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology
city: Barnaul
country: Russian Federation
facility: Multidisciplinary Medical Clinic "Anthurium"
city: Irkutsk
country: Russian Federation
facility: Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways
city: Kazan
country: Russian Federation
facility: SBEI HPE "Kazan State Medical University" of the MoH of the RF
city: Moscow
country: Russian Federation
facility: FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
city: Nizhniy Novgorod
country: Russian Federation
facility: SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
city: Novosibirsk
country: Russian Federation
facility: SBEIHPE Novosibirsk State Medical University
city: Novosibirsk
country: Russian Federation
facility: FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncology Dispensary"
city: Rostov-on-Don
country: Russian Federation
facility: SBEI HPE Rostov State Medical University of the MoH of the RF
city: Saint Petersburg
country: Russian Federation
facility: SBIH City Clinical Hospital #31
city: Saint-Peterburg
country: Russian Federation
facility: Union Clinic
city: Saint-Petersburg
country: Russian Federation
facility: FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH City Hospital # 26
city: Saint-Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: Samara
country: Russian Federation
facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"
city: Samara
country: Russian Federation
facility: LLC Medical Company Hepatologist
city: St. Petersburg
country: Russian Federation
facility: FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"
city: St.Petersburg
country: Russian Federation
facility: SPb SBIH Alexandrovskaya City Hospital
city: Stavropol
country: Russian Federation
facility: SBEI HPE "Stavropol State Medical Academy" MoH of RF
city: Vladimir
country: Russian Federation
facility: Regional Clinical Hospital
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara Clinic of Internal Diseases
city: Belgrade
country: Serbia
facility: Military Medical Academy, Clinic of Gastroenterology and Hepatology
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun Department of Gastroenterology
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology
city: Nis
country: Serbia
facility: Clinical Center Nis, Clinic of Gastroenterology and Hepatology
city: Zrenjanin
country: Serbia
facility: General Hospital Djordje Jovanovic Zrenjanin
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Bardejov
country: Slovakia
facility: Alian s.r.o.
city: Bratislava
country: Slovakia
facility: PRO SANUS, a.s., Poliklinika ProCare Central
city: Bratislava
country: Slovakia
facility: IBDcentrum s.r.o.
city: Ilava
country: Slovakia
facility: Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia
city: Kosice
country: Slovakia
facility: Gastroped s.r.o.
city: Malacky
country: Slovakia
facility: Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o.
city: Martin
country: Slovakia
facility: PIGEAS s.r.o.
city: Michalovce
country: Slovakia
facility: Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
city: Nove Zamky
country: Slovakia
facility: Gastromedic s.r.o.
city: Trnava
country: Slovakia
facility: EndoCorp s.r.o.
city: Cape Town
country: South Africa
facility: Dr MJ Prins Practice
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
city: Cape Town
country: South Africa
facility: Endocare Research
city: Cape Town
country: South Africa
facility: Dr JP Wright Practice
city: Johannesburg
country: South Africa
facility: Dr YS Nanabhay Practice
city: Pretoria
country: South Africa
facility: Emmed Research
city: Badalona
country: Spain
facility: University Hospital Germans Trias i Pujol
city: La Laguna
country: Spain
facility: University Hospital of the Canary Islands (HUC) La Laguna
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
city: Sevilla
country: Spain
facility: University Hospital Virgen del Rocio
city: Chernivtsi
country: Ukraine
facility: RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
city: Dnipropetrovsk
country: Ukraine
facility: Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
city: Ivano-Frankivsk
country: Ukraine
facility: Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
city: Kharkiv
country: Ukraine
facility: CI of PH Kharkiv CCH #2
city: Kharkiv
country: Ukraine
facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #1
city: Kyiv
country: Ukraine
facility: SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Regional Clinical Hospital #2
city: Kyiv
country: Ukraine
facility: Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
city: Kyiv
country: Ukraine
facility: Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
city: Sumy
country: Ukraine
facility: CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU
city: Sumy
country: Ukraine
facility: Sumy Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: CI of TRC Ternopil University Hospital
city: Uzhgorod
country: Ukraine
facility: A. Novak Transcarpathian Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: MCIC MC LLC Health Clinic
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War
city: Vinnytsia
country: Ukraine
facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
city: Vinnytsia
country: Ukraine
facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia M.I. Pyrohov National Medical University
city: Zaporizhia
country: Ukraine
facility: City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya
city: Zaporizhia
country: Ukraine
facility: Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology
city: Zaporizhia
country: Ukraine
facility: CI City Hospital #1
city: Zaporizhzhia
country: Ukraine
facility: CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU
city: Zaporizhzhia
country: Ukraine
facility: Zaporizhia Regional Clinical Hospital
city: Zhytomyr
country: Ukraine
facility: Central District Hospital under Zhytomyr District Council
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
Study officials:
affiliation: Celgene
name: AnnKatrin Petersen, M.D., MSc.
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Feagan BG, D'Haens G, Wolf DC, Jovanovic I, Hanauer SB, Ghosh S, Petersen A, Hua SY, Lee JH, Charles L, Chitkara D, Usiskin K, Colombel JF, Laine L, Danese S; True North Study Group. Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2021 Sep 30;385(14):1280-1291. doi: 10.1056/NEJMoa2033617.