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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02435992
Other study ID # RPC01-3101
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 17, 2015
Est. completion date June 17, 2020

Study information

Verified date August 2021
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 1012
Est. completion date June 17, 2020
Est. primary completion date March 27, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 ß-human chorionic gonadotropin (ß-hCG) measured during screening

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RPC1063

Placebo


Locations

Country Name City State
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 Royal Adelaide Hospital Adelaide South Australia
Australia Monash Medical Centre Clayton Bentleigh East
Australia Royal Prince Alfred Hospital Camperdown
Australia Centre For Digestive Diseases Five Dock New South Wales
Australia Nepean Hospital Kingswood New South Wales
Australia Cabrini Hospital Malvern Malvern Victoria
Australia The Alfred Hospital Melbourne Victoria
Australia Mater Hospital Brisbane South Brisbane Queensland
Australia Princess Alexandra Hospital Woolloongabba Queensland
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 City Clinic UMHAC EOOD Sofia
Bulgaria Fourth MHAT - Sofia EAD Sofia
Bulgaria MHAT "Lyulin", EAD Sofia
Bulgaria MHAT 'Tokuda Hospital Sofia', EAD Sofia
Bulgaria NMTH "Tsar Boris III" Sofia
Bulgaria UMHAT "SofiaMed", OOD Sofia
Bulgaria UMHAT 'Sveta Anna' AD Sofia
Bulgaria UMHAT 'Tsaritsa Yoanna - ISUL', EAD Sofia
Bulgaria Medical Center "Nov Rehabilitatsionen Tsentar", EOOD Stara Zagora
Bulgaria MHAT 'Sv. Marina', EAD Varna
Bulgaria MC Medica Plus Veliko Tarnovo
Canada Brandon Medical Arts Clinic Brandon Manitoba
Canada Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne Greenfield Park Quebec
Canada Viable Clinical Research - Lindsay Lindsay Ontario
Canada LHSC - University Hospital London Ontario
Canada LHSC - Victoria Hospital London Ontario
Canada The Ottawa Hospital - General Campus Ottawa Quebec
Canada CHUS - Hôpital Fleurimont Sherbrooke Quebec
Canada Humber River Hospital Toronto Ontario
Canada Mount Sinai Hospital Toronto Ontario
Canada Toronto Liver Centre Toronto Ontario
Canada Vancouver General Hospital Vancouver British Columbia
Canada Toronto Digestive Disease Associates, Inc. Vaughan Ontario
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 LLC Vivamedi Tbilisi
Georgia LTD Academician N.Kipshidze Central University Clinic Tbilisi
Georgia LTD Aversi Clinic Tbilisi
Georgia LTD Coloproctological Center Tbilisi
Georgia LTD Research Institute of Clinical Medicine Tbilisi
Germany Charite - Campus Virchow-Klinikum Berlin
Germany Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin Berlin
Germany DRK Kliniken Berlin Westend Berlin
Germany Medical Care Unit Dachau Dachau
Germany Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden
Germany Crohn Colitis Centrum Rhein Main Frankfurt
Germany Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Germany Universitaetsklinikum Freiburg Freiburg
Germany Asklepios Klinik Hamburg Hamburg
Germany Universitaetsklinikum Hamburg-Eppendorf 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 424th Army General Hospital Thessaloniki
Greece General Hospital of Thessaloniki Hippokration Thessaloniki
Hungary DRC Gyogyszervizsgalo Kozpont Kft Balatonfured
Hungary Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz Bekescsaba
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary Obudai Egeszsegugyi Centrum Kft. Budapest
Hungary Pannonia Maganorvosi Centrum Budapest
Hungary Semmelweis Egyetem 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 Seoul National University Bundang Hospital Seongnam
Korea, Republic of CHA Bundang Medical Center CHA University Seongnam-si,
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Ewha Womans University Mokdong Hospital Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University 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 "Sf. Arhanghel Mihail" Municipal Clinical Hospital Chisinau
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 Republican Clinical Hospital Chisinau
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands Vrije Universiteit Medisch Centrum (VUMC) 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 Bucharest University Emergency Hospital, Department of Internal Medicine II Bucharest
Romania Hyperclinica MedLife Grivita 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 FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS Novosibirsk
Russian Federation SBEIHPE Novosibirsk State Medical University 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 Pavlov First Saint Petersburg State Medical University Saint-Petersburg
Russian Federation SPb SBIH City Hospital # 26 Saint-Petersburg
Russian Federation LLC Medical Company Hepatologist Samara
Russian Federation Private Educational Institution of Higher Education "Medical University "REAVIZ" 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 Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology Belgrade
Serbia Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine Belgrade
Serbia Clinical Hospital Center Zemun 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 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 IBDcentrum s.r.o. Bratislava
Slovakia PRO SANUS, a.s., Poliklinika ProCare Central 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 JP Wright Practice Cape Town
South Africa Dr MJ Prins Practice Cape Town
South Africa Endocare Research Cape Town
South Africa Tiervlei Trial Centre 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 Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU Ivano-Frankivsk
Ukraine Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery 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 CI of Kyiv RC Regional Clinical Hospital #2 Kyiv
Ukraine Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU Kyiv
Ukraine Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE Kyiv
Ukraine Kyiv City Clinical Hospital #1 Kyiv
Ukraine SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU Kyiv
Ukraine Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU Lviv
Ukraine Lviv Regional Clinical Hospital 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 M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU Vinnytsia
Ukraine MCIC MC LLC Health Clinic Vinnytsia
Ukraine Vinnytsia M.I. Pyrohov National Medical University Vinnytsia
Ukraine Vinnytsia M.I. Pyrohov Regional Clinical Hospital Vinnytsia
Ukraine Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War Vinnytsia
Ukraine CI City Hospital #1 Zaporizhia
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 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 St Thomas' Hospital London
United Kingdom Whipps Cross University Hospital London
United Kingdom Royal Shrewsbury Hospital Shrewsbury
United States Anaheim Clinical Trials Anaheim California
United States University of Michigan Health System Ann Arbor Michigan
United States Asheville Gastroenterology Associates, P.A. Asheville North Carolina
United States Atlanta Gastroenterology Associates LLC Atlanta Georgia
United States Johns Hopkins Clinical Research Network Baltimore Maryland
United States University of Maryland Medical Group Baltimore Maryland
United States Woodholme Gastroenterology Baltimore Maryland
United States Gastroenterology Associates, LLC Baton Rouge Louisiana
United States Ehrhardt Clinical Research, LLC Belton Missouri
United States Boston Medical Center Boston Massachusetts
United States Clinical Research Professionals, LLC - De Paul Medical Dr Bridgeton Missouri
United States Commonwealth Clinical Studies, PLLC. Brockton Massachusetts
United States Montefiore Medical Center Bronx New York
United States NY Scientific Brooklyn New York
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Carolinas HealthCare System Digestive Health Charlotte North Carolina
United States University of Virginia Charlottesville Virginia
United States Gastroenterology Associates of Tidewater Chesapeake Virginia
United States Chevy Chase Clinical Research Chevy Chase Maryland
United States Northwestern University Feinberg Sch of Medicine Division of Gastroenterology Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States UC Health Clinical Trials Office Cincinnati Ohio
United States Clinical Research of West Florida Inc - Clearwater Clearwater Florida
United States Gastro Florida Clearwater Florida
United States The Cleveland Clinic Foundation Cleveland Ohio
United States Consultants in Gastroenterology, PA Columbia South Carolina
United States Gastro Center of Maryland Columbia Maryland
United States Ohio State University Clinical Trials Management Office Columbus Ohio
United States Aurora Care Clinic Costa Mesa California
United States Baylor Research Institute Dallas Texas
United States Advanced Pharma Research, Inc Delray Beach Florida
United States Dolphin Medical Research Doral Florida
United States Universal Axon Clinical Research Doral Florida
United States Brooke-Army Medical Center Fort Sam Houston Texas
United States Ventavia Research Group, LLC Fort Worth Texas
United States Valley View Internal Medicine Garden Grove California
United States Gastro One Germantown Tennessee
United States Long Island Clinical Research Associates Great Neck New York
United States Medical Research Center of Connecticut, LLC Hamden Connecticut
United States South Florida Clinical Trials Hialeah Florida
United States Gulf Coast Research Group LLC Houston Texas
United States Houston Endoscopy and Research Center Houston Texas
United States The Methodist Hospital Research Institute Houston Texas
United States Davita Clinical Trials, LLC Huntington Beach California
United States Grand Teton Research Group, PLLC Idaho Falls Idaho
United States Indiana University Hospital Indianapolis Indiana
United States East Carolina Gastroenterology, PA Jacksonville North Carolina
United States Kinston Medical Specialists, PA Kinston North Carolina
United States University of California San Diego Medical Center La Jolla California
United States OM Research Lancaster California
United States Florida Center for Gastroenterology Largo Florida
United States Mary Hitchcock Memorial Hospital Lebanon New Hampshire
United States University of Kentucky Medical Center Lexington Kentucky
United States Gastrointestinal Biosciences Los Angeles California
United States Southern California Research Institute Medical Group, Inc. Los Angeles California
United States UCLA Medical Center Los Angeles California
United States University of Southern California - Keck School of Medicine Los Angeles California
United States University of Louisville Louisville Kentucky
United States Gastrointestinal Specialists of Georgia, PC Marietta Georgia
United States Community Clinical Research Network Marlborough Massachusetts
United States Advanced Clincial Research Miami Florida
United States Advanced Clinical Research of Miami Miami Florida
United States City Medical Group Miami Florida
United States Regenerate Clinical Trials Miami Florida
United States Facey Medical Foundation (Parent) Mission Hills California
United States Advanced Research for Health Improvement Naples Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States Advanced Research Institute, Inc. New Port Richey Florida
United States NSB Research New Smyrna Beach Florida
United States Concord Medical Group PRIME New York New York
United States Icahn School of Medicine Mount Sinai Beth Isreal New York New York
United States Mount Sinai - PRIME New York New York
United States New York University School of Medicine New York New York
United States Weill Cornell Medical College New York New York
United States Arkansas Gastroenterology, P.A. North Little Rock Arkansas
United States Harmony Clinical Research North Miami Beach Florida
United States Med-Care Research North Miami Beach Florida
United States DM Clinical Research Oak Lawn Illinois
United States Alliance Clinical Research, LLC Oceanside California
United States Digestive Disease Specialists Oklahoma City Oklahoma
United States University of Oklahoma Oklahoma City Oklahoma
United States Gastroenterology Associates of Orangeburg Orangeburg South Carolina
United States Center For Digestive Health Orlando Florida
United States IMIC, Inc. Palmetto Bay Florida
United States DBC Research, Corp Pembroke Pines Florida
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Theia Clinical Research, LLC Pinellas Park Florida
United States Oregon Health & Science University Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States PMG Research of Rocky Mount, LLC Rocky Mount North Carolina
United States Clinical Research Professionals LLC - The Pines Court Saint Louis Missouri
United States Clinical Research Professionals, LLC - Olde Cabin Rd Saint Louis Missouri
United States Washington University Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States Gastroenterology Research of San Antonio, LLC San Antonio Texas
United States San Antonio Gastroenterology San Antonio Texas
United States Medical Associates Research Group, Inc. San Diego California
United States University of California at San Francisco (PARENT) San Francisco California
United States Benaroya Research Institute at Virginia Mason Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Texas Digestive Disease Consultants - Southlake Southlake Texas
United States Spring Gastroenterology Spring Texas
United States Clinical Inquest Center Ltd Springfield Ohio
United States Mercy Research Springfield Missouri
United States Arizona Digestive Health Sun City Arizona
United States Cotton-O'Neil Clinical Research Center, Digestive Health Topeka Kansas
United States Charm City Research Group Towson Maryland
United States Center For Digestive Health Troy Michigan
United States Adobe Clinical Research LLC Tucson Arizona
United States Digestive Health Specialists of Tyler Tyler Texas
United States Carle Foundation Hospital Urbana Illinois
United States Gastroenterology, LTD Virginia Beach Virginia
United States Florida Medical Clinic, P.A. Zephyrhills Florida

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bulgaria,  Canada,  Croatia,  Czechia,  Georgia,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Moldova, Republic of,  Netherlands,  New Zealand,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants in Clinical Remission at 10 Weeks Percentage of participants that are in Clinical remission at 10 weeks At 10 Weeks
Primary Percentage of Participants in Clinical Remission at 52 Weeks Percentage of participants that are in Clinical remission at 52 weeks At 52 Weeks
Secondary Percentage of Participants With Clinical Response at 10 Weeks Percentage of participants that are in Clinical response at 10 weeks At 10 Weeks
Secondary Percentage of Participants With Endoscopic Improvement at 10 Weeks Percentage of participants with endoscopic improvement at 10 weeks At 10 Weeks
Secondary Percentage of Participants With Mucosal Healing at 10 Weeks Percentage of participants with mucosal healing at 10 weeks At 10 Weeks
Secondary Percentage of Participants in Clinical Response at 52 Weeks Percentage of participants that are in Clinical response at 52 weeks At 52 Weeks
Secondary Percentage of Participants With Endoscopic Improvement at 52 Weeks Percentage of participants with endoscopic improvement at 52 weeks At 52 Weeks
Secondary Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10 Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10 At 52 Weeks
Secondary Percentage of Participants With Corticosteroid Free Remission at 52 Weeks Percentage of participants with corticosteroid free remission at 52 weeks At 52 Weeks
Secondary Percentage of Participants With Mucosal Healing at 52 Weeks Percentage of participants with Mucosal Healing at 52 weeks At 52 Weeks
Secondary Percentage of Participants With Durable Clinical Remission at 52 Weeks Percentage of participants with durable clinical remission at 52 weeks At 52 Weeks
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