Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT02435992 Completed May 6, 2015 July 9, 2020

study description
Brief Summary

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

Condition or Disease: Ulcerative Colitis
Intervention/treatment: Drug: RPC1063
Drug: Placebo
Phase: Phase 3
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 3 separate cohorts (Cohort 1 and Cohort 2 for
adults, Cohort 3 for adolescents). Patients from Cohort 1, 2, and 3 in clinical response at
the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort
1, 2, and 3 who participate in this trial may also qualify to participate in an optional
Open-Label Extension (OLE) trial.


study design
Study Type: Interventional
Estimated Enrollment : 1012 participants
Intervention Model : Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date: June 2015
Actual Primary Completion Date: March 2020
Actual Study Completion Date: June 2020

Arms and interventions
Arm Intervention/treatment
Experimental: RPC1063 (Ozanimod)
1mg, daily oral administration during Induction and Maintenance periods.
Drug: RPC1063
Placebo Comparator: Placebo
Daily oral administration during Induction and Maintenance periods.
Drug: Placebo
outcome measures
Primary Outcome Measures: 1. Clinical remission assessed by Mayo component sub-scores [ Time Frame: Week 10 ]
Induction Period
2. Clinical remission assessed by Mayo component sub-scores [ Time Frame: Week 52 ]
Maintenance Period

Eligibility Criteria
Ages Eligible for Study: 12 to 75 Years (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Aged 18 to 75 years (at screening for Cohort 1 and 2)

- Male or female adolescent patients aged 12 to < 18 years (at screening) with a body weight greater than or equal to 45 kg - 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


Contacts and Locations
Contacts
Locations
United States, Arizona Arizona Digestive Health Sun City
United States, Arizona Adobe Clinical Research LLC Tucson
United States, Arkansas Arkansas Gastroenterology, P.A. North Little Rock
United States, California Anaheim Clinical Trials Anaheim
United States, California Aurora Care Clinic Costa Mesa
United States, California Valley View Internal Medicine Garden Grove
United States, California Davita Clinical Trials, LLC Huntington Beach
United States, California University of California San Diego Medical Center La Jolla
United States, California OM Research Lancaster
United States, California University of Southern California - Keck School of Medicine Los Angeles
United States, California Southern California Research Institute Medical Group, Inc. Los Angeles
United States, California Gastrointestinal Biosciences Los Angeles
United States, California UCLA Medical Center Los Angeles
United States, California Facey Medical Foundation (Parent) Mission Hills
United States, California Alliance Clinical Research, LLC Oceanside
United States, California Medical Associates Research Group, Inc. San Diego
United States, California University of California at San Francisco (PARENT) San Francisco
United States, Connecticut Medical Research Center of Connecticut, LLC Hamden
United States, Florida Gastro Florida Clearwater
United States, Florida Clinical Research of West Florida Inc - Clearwater Clearwater
United States, Florida Advanced Pharma Research, Inc Delray Beach
United States, Florida Universal Axon Clinical Research Doral
United States, Florida Dolphin Medical Research Doral
United States, Florida South Florida Clinical Trials Hialeah
United States, Florida Florida Center for Gastroenterology Largo
United States, Florida City Medical Group Miami
United States, Florida Advanced Clincial Research Miami
United States, Florida Advanced Clinical Research of Miami Miami
United States, Florida Regenerate Clinical Trials Miami
United States, Florida Advanced Research for Health Improvement Naples
United States, Florida Advanced Research Institute, Inc. New Port Richey
United States, Florida NSB Research New Smyrna Beach
United States, Florida Harmony Clinical Research North Miami Beach
United States, Florida Med-Care Research North Miami Beach
United States, Florida Center For Digestive Health Orlando
United States, Florida IMIC, Inc. Palmetto Bay
United States, Florida DBC Research, Corp Pembroke Pines
United States, Florida Theia Clinical Research, LLC Pinellas Park
United States, Florida Florida Medical Clinic, P.A. Zephyrhills
United States, Georgia Atlanta Gastroenterology Associates LLC Atlanta
United States, Georgia Gastrointestinal Specialists of Georgia, PC Marietta
United States, Idaho Grand Teton Research Group, PLLC Idaho Falls
United States, Illinois Northwestern University Feinberg Sch of Medicine Division of Gastroenterology Chicago
United States, Illinois University of Chicago Medical Center Chicago
United States, Illinois DM Clinical Research Oak Lawn
United States, Illinois Carle Foundation Hospital Urbana
United States, Indiana Indiana University Hospital Indianapolis
United States, Kansas Cotton-O'Neil Clinical Research Center, Digestive Health Topeka
United States, Kentucky University of Kentucky Medical Center Lexington
United States, Kentucky University of Louisville Louisville
United States, Louisiana Gastroenterology Associates, LLC Baton Rouge
United States, Maryland University of Maryland Medical Group Baltimore
United States, Maryland Woodholme Gastroenterology Baltimore
United States, Maryland Johns Hopkins Clinical Research Network Baltimore
United States, Maryland Chevy Chase Clinical Research Chevy Chase
United States, Maryland Gastro Center of Maryland Columbia
United States, Maryland Charm City Research Group Towson
United States, Massachusetts Boston Medical Center Boston
United States, Massachusetts Commonwealth Clinical Studies, PLLC. Brockton
United States, Massachusetts Community Clinical Research Network Marlborough
United States, Michigan University of Michigan Health System Ann Arbor
United States, Michigan Center For Digestive Health Troy
United States, Minnesota Mayo Clinic Rochester
United States, Missouri Ehrhardt Clinical Research, LLC Belton
United States, Missouri Clinical Research Professionals, LLC - De Paul Medical Dr Bridgeton
United States, Missouri Washington University Saint Louis
United States, Missouri Clinical Research Professionals LLC - The Pines Court Saint Louis
United States, Missouri Clinical Research Professionals, LLC - Olde Cabin Rd Saint Louis
United States, Missouri Mercy Research Springfield
United States, New Hampshire Mary Hitchcock Memorial Hospital Lebanon
United States, New York Montefiore Medical Center Bronx
United States, New York NY Scientific Brooklyn
United States, New York Long Island Clinical Research Associates Great Neck
United States, New York Icahn School of Medicine Mount Sinai Beth Isreal New York
United States, New York Concord Medical Group PRIME New York
United States, New York New York University School of Medicine New York
United States, New York Weill Cornell Medical College New York
United States, New York Mount Sinai - PRIME New York
United States, North Carolina Asheville Gastroenterology Associates, P.A. Asheville
United States, North Carolina University of North Carolina at Chapel Hill Chapel Hill
United States, North Carolina Carolinas HealthCare System Digestive Health Charlotte
United States, North Carolina East Carolina Gastroenterology, PA Jacksonville
United States, North Carolina Kinston Medical Specialists, PA Kinston
United States, North Carolina PMG Research of Rocky Mount, LLC Rocky Mount
United States, Ohio UC Health Clinical Trials Office Cincinnati
United States, Ohio The Cleveland Clinic Foundation Cleveland
United States, Ohio Ohio State University Clinical Trials Management Office Columbus
United States, Ohio Clinical Inquest Center Ltd Springfield
United States, Oklahoma University of Oklahoma Oklahoma City
United States, Oklahoma Digestive Disease Specialists Oklahoma City
United States, Oregon Oregon Health & Science University Portland
United States, Pennsylvania Hospital of the University of Pennsylvania Philadelphia
United States, South Carolina Consultants in Gastroenterology, PA Columbia
United States, South Carolina Gastroenterology Associates of Orangeburg Orangeburg
United States, Tennessee Gastro One Germantown
United States, Tennessee Vanderbilt University Medical Center Nashville
United States, Texas Baylor Research Institute Dallas
United States, Texas Brooke-Army Medical Center Fort Sam Houston
United States, Texas Ventavia Research Group, LLC Fort Worth
United States, Texas Gulf Coast Research Group LLC Houston
United States, Texas The Methodist Hospital Research Institute Houston
United States, Texas Houston Endoscopy and Research Center Houston
United States, Texas Gastroenterology Research of San Antonio, LLC San Antonio
United States, Texas San Antonio Gastroenterology San Antonio
United States, Texas Texas Digestive Disease Consultants - Southlake Southlake
United States, Texas Spring Gastroenterology Spring
United States, Texas Digestive Health Specialists of Tyler Tyler
United States, Utah University of Utah Salt Lake City
United States, Virginia University of Virginia Charlottesville
United States, Virginia Gastroenterology Associates of Tidewater Chesapeake
United States, Virginia Gastroenterology, LTD Virginia Beach
United States, Washington Benaroya Research Institute at Virginia Mason Seattle
United States, Washington University of Washington Medical Center Seattle
Argentina Hospital Italiano Buenos Aires
Argentina Instituto DAMIC Fundacion Rusculleda Cordoba
Argentina Hospital Italiano de La Plata La Plata
Argentina Instituto Medico CER Quilmes
Argentina Instituto Medico de la Fundacion Estudios Clinicos Rosario
Australia, New South Wales Centre For Digestive Diseases Five Dock
Australia, New South Wales Nepean Hospital Kingswood
Australia, Queensland Mater Hospital Brisbane South Brisbane
Australia, Queensland Princess Alexandra Hospital Woolloongabba
Australia, South Australia Royal Adelaide Hospital Adelaide
Australia, Victoria Cabrini Hospital Malvern Malvern
Australia, Victoria The Alfred Hospital Melbourne
Australia Monash Medical Centre Clayton Bentleigh East
Australia Royal Prince Alfred Hospital Camperdown
Austria Medical University Vienna Vienna
Belarus Gomel Regional Clinical Hospital Gomel
Belarus City Clinical Hospital No 10 Minsk
Belarus Vitebsk Regional Clinical Hospital Vitebsk
Belgium Imeldaziekenhuis Bonheiden
Belgium AZ Maria Middelares Gent
Belgium Universitair Ziekenhuis Gent Gent
Belgium UZ Leuven Leuven
Belgium CHC - Clinique St-Jospeh Liege
Bulgaria Medical Centre "Asklepii", OOD Dupnitsa
Bulgaria UMHAT 'Dr. Georgi Stranski', EAD Pleven
Bulgaria UMHAT "Kaspela", EOOD Plovdiv
Bulgaria MC Rusemed ltd. Ruse
Bulgaria NMTH "Tsar Boris III" Sofia
Bulgaria MHAT "Lyulin", EAD Sofia
Bulgaria City Clinic UMHAC EOOD Sofia
Bulgaria MHAT 'Tokuda Hospital Sofia', EAD Sofia
Bulgaria UMHAT 'Tsaritsa Yoanna - ISUL', EAD Sofia
Bulgaria Fourth MHAT - Sofia EAD Sofia
Bulgaria UMHAT 'Sveta Anna' AD Sofia
Bulgaria UMHAT "SofiaMed", OOD Sofia
Bulgaria Medical Center "Nov Rehabilitatsionen Tsentar", EOOD Stara Zagora
Bulgaria MHAT 'Sv. Marina', EAD Varna
Bulgaria MC Medica Plus Veliko Tarnovo
Canada, British Columbia Vancouver General Hospital Vancouver
Canada, Manitoba Brandon Medical Arts Clinic Brandon
Canada, Ontario Viable Clinical Research - Lindsay Lindsay
Canada, Ontario LHSC - University Hospital London
Canada, Ontario LHSC - Victoria Hospital London
Canada, Ontario Humber River Hospital Toronto
Canada, Ontario Mount Sinai Hospital Toronto
Canada, Ontario Toronto Liver Centre Toronto
Canada, Ontario Toronto Digestive Disease Associates, Inc. Vaughan
Canada, Quebec Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne Greenfield Park
Canada, Quebec The Ottawa Hospital - General Campus Ottawa
Canada, Quebec CHUS - Hôpital Fleurimont Sherbrooke
Croatia Clinical Hospital Center Osijek Osijek
Croatia Clinical Hospital Centre Rijeka Rijeka
Croatia Clinical Hospital "Sveti Duh", Clinic of Internal Diseases Zagreb
Croatia Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases Zagreb
Croatia Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology Zagreb
Czechia Vojenska nemocnice Brno Brno
Czechia Hepato-Gastroenterologie HK, s.r.o. Hradec Kralove
Czechia GASTRO JeKa s.r.o. Klatovy
Czechia Gregar s.r.o. Olomouc
Czechia PreventaMed Olomouc
Czechia ISCARE, a.s. Prague 9
Czechia Institut klinicke a experimentalni mediciny Praha 4
Czechia Thomayerova nemocnice Praha 4
Czechia Nemocnice Slany Slany
Georgia LTD Research Institute of Clinical Medicine Tbilisi
Georgia LLC Vivamedi Tbilisi
Georgia LTD Academician N.Kipshidze Central University Clinic Tbilisi
Georgia LTD Aversi Clinic Tbilisi
Georgia LTD Coloproctological Center Tbilisi
Germany Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin Berlin
Germany Charite - Campus Virchow-Klinikum Berlin
Germany DRK Kliniken Berlin Westend Berlin
Germany Medical Care Unit Dachau Dachau
Germany Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden
Germany Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Germany Crohn Colitis Centrum Rhein Main Frankfurt
Germany Universitaetsklinikum Freiburg Freiburg
Germany Universitaetsklinikum Hamburg-Eppendorf Hamburg
Germany Asklepios Klinik Hamburg Hamburg
Germany Medizinische Hochschule Hannover Hannover
Germany Universitaetsklinikum Koeln Koeln
Germany EUGASTRO GmbH Leipzig
Germany Universitaetsklinikum Schleswig-Holstein - Campus Luebeck Luebeck
Germany Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Mainz
Germany Universitatsklinikum Ulm Ulm
Greece Laiko General Hospital of Athens Athens
Greece University General Hospital of Heraklion Heraklion
Greece University General Hospital of Larissa Larissa Thessaly
Greece General Hospital of Thessaloniki Hippokration Thessaloniki
Greece 424th Army General Hospital Thessaloniki
Hungary DRC Gyogyszervizsgalo Kozpont Kft Balatonfured
Hungary Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz Bekescsaba
Hungary Obudai Egeszsegugyi Centrum Kft. Budapest
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Pannonia Maganorvosi Centrum Budapest
Hungary Szent Margit Korhaz Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza Gyula
Hungary Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont Letavertes
Hungary Mohacsi Korhaz Mohacs
Hungary SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz Nyiregyhaza
Hungary Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar
Israel Wolfson Medical Center Holon
Israel Shaare Zedek Medical Center Jerusalem
Israel Meir Medical Center Kfar Saba
Israel Chaim Sheba Medical Center Ramat Gan
Israel Kaplan Medical Center Rechovot
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Italy Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi Bologna
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy Azienda Ospedaliero Universitaria San Martino Genova
Italy Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco Milano
Italy A.O.U. Policlinico di Modena Modena
Italy Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) Monza
Italy Azienda Ospedaliera Universitaria "Federico II" Napoli
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Italy Azienda Ospedaliero Universitaria Pisana Pisa
Italy Complesso Integrato Columbus Roma
Italy Istituto Clinico Humanitas Rozzano (MI)
Italy IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo FG
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Konyang University Hospital Daejeon
Korea, Republic of Hanyang Univerisy Guri Hospital Guri-si
Korea, Republic of CHA Bundang Medical Center CHA University Seongnam-si,
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Seoul
Korea, Republic of Ewha Womans University Mokdong Hospital Seoul
Korea, Republic of The Catholic University of Korea, St.Vicent's Hospital Suwon
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju-Si
Latvia Pauls Stradins Clinical University Hospital Riga
Moldova, Republic of "Sfanta Treime" Clinical Municipal Hospital Chisinau
Moldova, Republic of Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery Chisinau
Moldova, Republic of "Sf. Arhanghel Mihail" Municipal Clinical Hospital Chisinau
Moldova, Republic of Republican Clinical Hospital Chisinau
Netherlands Vrije Universiteit Medisch Centrum (VUMC) Amsterdam
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands Universitair Medisch Centrum Groningen (UMCG) Groningen
Netherlands Maastricht University Medical Center Maastrich
Netherlands Zuyderland Medisch Centrum - Sittard-Geleen Sittard-Geleen
Netherlands ETZ Elisabeth Tilburg
New Zealand Christchurch Hospital NZ Christchurch
New Zealand Dunedin Public Hospital Dunedin
Poland Clinsante S.C. Osrodek Badan Klinicznych Bydgoszcz
Poland Specjalistyczna Przychodnia Lekarska Medicus Chorzow
Poland GLOBE Clinical Research Sp. z o.o. LLC Klodzko
Poland PLEJADY Sp. z o.o. (LLC) Medical Centre Krakow
Poland Centrum Medyczne A-Z Clinic Kraków
Poland Healthcare Center Orkan Med Stec Michalska Spolka Jawna Ksawerow
Poland Santa Familia Centrum Badan, Profilaktyki i Leczenia Lodz
Poland KO-MED Centra Kliniczne Lublin II Lublin
Poland Trialmed Llc Piotrkow Trybunalski
Poland SOLUMED Centrum Medyczne Poznan
Poland Specjalistyczna Praktyka Lekarska dr med. Marek Horynski Sopot
Poland KO-MED Centra Kliniczne Staszow Staszow
Poland GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe Torun
Poland MDM Healthcare Centre Warsaw
Poland Nzoz Vivamed Warsaw
Poland Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice Wierzchoslawice
Poland LexMedica Osrodek Badan Klinicznych Wroclaw
Romania Bacau County Emergency Hospital, Department of Gastroenterology Bacau
Romania Hyperclinica MedLife Grivita Bucharest
Romania Bucharest University Emergency Hospital, Department of Internal Medicine II Bucharest
Romania TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy Cluj-Napoca
Romania Sf. Apostol Andrei Constanta Emergency Clinical County Hospital Constanta
Romania Craiova County Emergency Clinical Hospital Craiova
Romania "Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology Timisoara
Russian Federation Multidisciplinary Medical Clinic "Anthurium" Barnaul
Russian Federation Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways Irkutsk
Russian Federation SBEI HPE "Kazan State Medical University" of the MoH of the RF Kazan
Russian Federation FSBIH "Central Clinical Hospital of Russian Academy of Sciences" Moscow
Russian Federation SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko" Nizhniy Novgorod
Russian Federation SBEIHPE Novosibirsk State Medical University Novosibirsk
Russian Federation FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS Novosibirsk
Russian Federation BHI of Omsk region "Clinical Oncology Dispensary" Omsk
Russian Federation SBEI HPE Rostov State Medical University of the MoH of the RF Rostov-on-Don
Russian Federation SBIH City Clinical Hospital #31 Saint Petersburg
Russian Federation Union Clinic Saint-Peterburg
Russian Federation FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia Saint-Petersburg
Russian Federation SPb SBIH City Hospital # 26 Saint-Petersburg
Russian Federation Pavlov First Saint Petersburg State Medical University Saint-Petersburg
Russian Federation Private Educational Institution of Higher Education "Medical University "REAVIZ" Samara
Russian Federation LLC Medical Company Hepatologist Samara
Russian Federation FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine" St. Petersburg
Russian Federation SPb SBIH Alexandrovskaya City Hospital St.Petersburg
Russian Federation SBEI HPE "Stavropol State Medical Academy" MoH of RF Stavropol
Russian Federation Regional Clinical Hospital Vladimir
Serbia Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine Belgrade
Serbia Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology Belgrade
Serbia Clinical Hospital Center Zvezdara Clinic of Internal Diseases Belgrade
Serbia Military Medical Academy, Clinic of Gastroenterology and Hepatology Belgrade
Serbia Clinical Hospital Center Zemun Department of Gastroenterology Belgrade
Serbia Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology Kragujevac
Serbia Clinical Center Nis, Clinic of Gastroenterology and Hepatology Nis
Serbia General Hospital Djordje Jovanovic Zrenjanin Zrenjanin
Slovakia Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Slovakia Alian s.r.o. Bardejov
Slovakia PRO SANUS, a.s., Poliklinika ProCare Central Bratislava
Slovakia IBDcentrum s.r.o. Bratislava
Slovakia Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia Ilava
Slovakia Gastroped s.r.o. Kosice
Slovakia Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o. Malacky
Slovakia PIGEAS s.r.o. Martin
Slovakia Nemocnica s poliklinikou S. Kukuru Michalovce, a.s. Michalovce
Slovakia Gastromedic s.r.o. Nove Zamky
Slovakia EndoCorp s.r.o. Trnava
South Africa Dr MJ Prins Practice Cape Town
South Africa Tiervlei Trial Centre Cape Town
South Africa Endocare Research Cape Town
South Africa Dr JP Wright Practice Cape Town
South Africa Dr YS Nanabhay Practice Johannesburg
South Africa Emmed Research Pretoria
Spain University Hospital Germans Trias i Pujol Badalona
Spain University Hospital of the Canary Islands (HUC) La Laguna La Laguna
Spain Hospital Universitario de Gran Canaria Dr. Negrin Las Palmas de Gran Canaria
Spain University Hospital Virgen del Rocio Sevilla
Ukraine RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU Chernivtsi
Ukraine Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital Dnipropetrovsk
Ukraine Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases Dnipropetrovsk
Ukraine Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU Ivano-Frankivsk
Ukraine Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU Ivano-Frankivsk
Ukraine CI of PH Kharkiv CCH #2 Kharkiv
Ukraine GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine Kharkiv
Ukraine Kyiv City Clinical Hospital #1 Kyiv
Ukraine SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU Kyiv
Ukraine CI of Kyiv RC Regional Clinical Hospital #2 Kyiv
Ukraine Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE Kyiv
Ukraine Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU Kyiv
Ukraine Lviv Regional Clinical Hospital Lviv
Ukraine Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU Lviv
Ukraine CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Sumy
Ukraine Sumy Regional Clinical Hospital Sumy
Ukraine CI of TRC Ternopil University Hospital Ternopil
Ukraine A. Novak Transcarpathian Regional Clinical Hospital Uzhgorod
Ukraine MCIC MC LLC Health Clinic Vinnytsia
Ukraine Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War Vinnytsia
Ukraine M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU Vinnytsia
Ukraine Vinnytsia M.I. Pyrohov Regional Clinical Hospital Vinnytsia
Ukraine Vinnytsia M.I. Pyrohov National Medical University Vinnytsia
Ukraine City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya Zaporizhia
Ukraine Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology Zaporizhia
Ukraine CI City Hospital #1 Zaporizhia
Ukraine CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU Zaporizhzhia
Ukraine Zaporizhia Regional Clinical Hospital Zaporizhzhia
Ukraine Central District Hospital under Zhytomyr District Council Zhytomyr
United Kingdom University Hospital Coventry Coventry
United Kingdom Royal Devon and Exeter Hospital (Wonford) Exeter
United Kingdom Gloucestershire Royal Hospital Gloucester
United Kingdom Whipps Cross University Hospital London
United Kingdom St Thomas' Hospital London
United Kingdom Royal Shrewsbury Hospital Shrewsbury
Sponsors and Collaborators
Celgene
Investigator
Study Director : AnnKatrin Petersen, M.D., MSc. Celgene
More Information
Responsible Party : Celgene
ClinicalTrials.gov Identifier : NCT02435992     
Other Study ID Numbers : RPC01-3101
First Posted : May 6, 2015
Last Update Posted : July 9, 2020
Last Verified : July 2020
Additional relevant MeSH terms :
Colitis
Colitis, Ulcerative
Ulcer