An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02531126 |
Recruitment Status :
Active, not recruiting
First Posted : August 24, 2015
Last Update Posted : January 13, 2023
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Drug: RPC1063 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 878 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis |
Actual Study Start Date : | December 2, 2015 |
Estimated Primary Completion Date : | February 27, 2025 |
Estimated Study Completion Date : | February 27, 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: RPC0163 (Ozanimod) |
Drug: RPC1063
Other Name: Ozanimod |
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
- Number of Participants with Adverse Events (AEs) [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
- Number of Participants with TEAEs Leading to Discontinuation of Investigational Drug [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
- Number of Participants with Adverse Events of Special Interest [ Time Frame: From enrollment until at least 90 days after completion of study treatment ]
- Proportion of participants with clinical remission [ Time Frame: Up to 6 years ]
- Proportion of participants with a clinical response [ Time Frame: Up to 6 years ]
- Proportion of participants with endoscopic improvement [ Time Frame: Up to 6 years ]
- Proportion of participants with mucosal healing [ Time Frame: Up to 6 years ]
- Proportion of participants with corticosteroid-free remission [ Time Frame: Up to 6 years ]
- Change from Baseline in complete Mayo score [ Time Frame: Up to 6 years ]
- Change from Baseline in partial Mayo score [ Time Frame: Up to 6 years ]
- Change from Baseline in 9-point Mayo score [ Time Frame: Up to 6 years ]
- Proportion of participants with histologic remission [ Time Frame: Up to 6 years ]
- Proportion of participants with clinical response in participants who had previously received anti-TNF therapy [ Time Frame: Up to 6 years ]
- Proportion of participants with clinical remission in participants who had previously received anti-TNF therapy [ Time Frame: Up to 6 years ]
- Proportion of participants with endoscopic improvement in participants who had previously received anti-TNF therapy [ Time Frame: Up to 6 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Inclusion Criteria:
• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
Exclusion Criteria:
- Receiving treatment with breast cancer resistance protein inhibitors
- Clinically relevant cardiovascular conditions
- Liver function impairment
Other protocol-defined inclusion/exclusion criteria apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531126


United States, Arizona | |
Adobe Clinical Research LLC | |
Tucson, Arizona, United States, 85712 | |
United States, Arkansas | |
Arkansas Gastroenterology, P.A. | |
North Little Rock, Arkansas, United States, 72117 | |
Local Institution - 212 | |
North Little Rock, Arkansas, United States, 72117 | |
United States, California | |
Anaheim Clinical Trials | |
Anaheim, California, United States, 92801 | |
Local Institution - 102 | |
Anaheim, California, United States, 92801 | |
Aurora Care Clinic | |
Costa Mesa, California, United States, 92627 | |
University of California San Diego Medical Center | |
La Jolla, California, United States, La Jolla | |
Local Institution - 230 | |
Lancaster, California, United States, 93534 | |
OM Research | |
Lancaster, California, United States, 93534 | |
Facey Medical Foundation (Parent) | |
Mission Hills, California, United States, 91345 | |
Alliance Clinical Research, LLC | |
Oceanside, California, United States, 92056-4497 | |
Medical Associates Research Group, Inc. | |
San Diego, California, United States, 92123 | |
Local Institution - 224 | |
San Francisco, California, United States, 94115 | |
University of California at San Francisco (PARENT) | |
San Francisco, California, United States, 94115 | |
United States, Florida | |
Local Institution - 113 | |
Clearwater, Florida, United States, 33762 | |
West Central Gastroenterology d/b/a Gastro Florida | |
Clearwater, Florida, United States, 33762 | |
Florida Center for Gastroenterology | |
Largo, Florida, United States, 33777 | |
Regenerate Clinical Trials | |
Miami, Florida, United States, 33155 | |
NSB Research | |
New Smyrna Beach, Florida, United States, 32168 | |
Harmony Clinical Research | |
North Miami Beach, Florida, United States, 33162 | |
Center For Digestive Health | |
Orlando, Florida, United States, 32803 | |
Local Institution - 190 | |
Orlando, Florida, United States, 32803 | |
IMIC, Inc. | |
Palmetto Bay, Florida, United States, 33157 | |
Theia Clinical Research, LLC | |
Pinellas Park, Florida, United States, 33781 | |
Florida Medical Clinic, P.A. | |
Zephyrhills, Florida, United States, 33613 | |
United States, Georgia | |
Atlanta Gastroenterology Associates LLC | |
Atlanta, Georgia, United States, 30342 | |
Gastrointestinal Specialists of Georgia, PC | |
Marietta, Georgia, United States, 30060 | |
United States, Idaho | |
Grand Teton Research Group, PLLC | |
Idaho Falls, Idaho, United States, 83404 | |
United States, Illinois | |
Southwest Gastroenterology | |
Oak Lawn, Illinois, United States, 60453 | |
United States, Kentucky | |
University of Kentucky Medical Center | |
Lexington, Kentucky, United States, 40536 | |
United States, Louisiana | |
Gastroenterology Associates, LLC | |
Baton Rouge, Louisiana, United States, 70809 | |
Local Institution - 119 | |
Baton Rouge, Louisiana, United States, 70809 | |
United States, Maryland | |
University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
Woodholme Gastroenterology | |
Baltimore, Maryland, United States, 21209 | |
Johns Hopkins Clinical Research Network | |
Baltimore, Maryland, United States, 21287 | |
Local Institution - 225 | |
Baltimore, Maryland, United States, 21287 | |
Chevy Chase Clinical Research | |
Chevy Chase, Maryland, United States, 20815 | |
Charm City Research Group | |
Towson, Maryland, United States, 21204 | |
United States, Massachusetts | |
Boston Medical Center Boston Univ School of Medicine | |
Boston, Massachusetts, United States, 02118 | |
Local Institution - 128 | |
Boston, Massachusetts, United States, 02118 | |
United States, Minnesota | |
Local Institution - 216 | |
Rochester, Minnesota, United States, 55905 | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Ehrhardt Clinical Research, LLC | |
Belton, Missouri, United States, 64012 | |
Clinical Research Professionals, LLC - De Paul Medical Dr | |
Bridgeton, Missouri, United States, 63044 | |
Clinical Research Professionals, LLC - Olde Cabin Rd | |
Saint Louis, Missouri, United States, 63141 | |
United States, New Hampshire | |
Mary Hitchcock Memorial Hospital | |
Lebanon, New Hampshire, United States, 07756 | |
United States, New York | |
Centex Studies-Webster | |
Brooklyn, New York, United States, 11235 | |
Long Island Clinical Research Associates | |
Great Neck, New York, United States, 11021 | |
Concord Medical Group PRIME | |
New York, New York, United States, 10016 | |
New York University School of Medicine | |
New York, New York, United States, 10016 | |
Local Institution - 120 | |
New York, New York, United States, 10029 | |
Mount Sinai - PRIME | |
New York, New York, United States, 10029 | |
Weill Cornell Medical College | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
Carolinas HealthCare System Digestive Health | |
Charlotte, North Carolina, United States, 28204 | |
East Carolina Gastroenterology, PA | |
Jacksonville, North Carolina, United States, 28546 | |
Local Institution - 141 | |
Rocky Mount, North Carolina, United States, 27804 | |
PMG Research of Rocky Mount, LLC | |
Rocky Mount, North Carolina, United States, 27804 | |
United States, Ohio | |
Clinical Inquest Center Ltd | |
Beavercreek, Ohio, United States, 45431 | |
Consultants for Clinical Research Inc. | |
Cincinnati, Ohio, United States, 45219 | |
UC Health Clinical Trials Office | |
Cincinnati, Ohio, United States, 45267 | |
Ohio State University Clinical Trials Management Office | |
Columbus, Ohio, United States, 43210 | |
United States, Oklahoma | |
University of Oklahoma Peggy and Charles Stephenson Cancer Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
Digestive Disease Specialists | |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, South Carolina | |
Consultants in Gastroenterology, PA | |
Columbia, South Carolina, United States, 29203 | |
Local Institution - 214 | |
Columbia, South Carolina, United States, 29203 | |
Gastroenterology Associates of Orangeburg | |
Orangeburg, South Carolina, United States, 29118 | |
United States, Tennessee | |
Gastro One | |
Germantown, Tennessee, United States, 38138 | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37212 | |
United States, Texas | |
Texas Digestive Disease Consultants Dallas | |
Dallas, Texas, United States, 75231 | |
Baylor Research Institute - Dallas Clinical Trials Office | |
Dallas, Texas, United States, 75246 | |
Brooke Army Medical Center Francis Street Medical Center | |
Fort Sam Houston, Texas, United States, 78235-8200 | |
Local Institution - 137 | |
Fort Sam Houston, Texas, United States, 78235-8200 | |
Ventavia Research Group, LLC | |
Fort Worth, Texas, United States, 76104 | |
The Methodist Hospital Research Institute | |
Houston, Texas, United States, 77030 | |
Houston Endoscopy and Research Center | |
Houston, Texas, United States, 77079 | |
Gulf Coast Research Group LLC | |
Houston, Texas, United States, 77098 | |
Local Institution - 217 | |
San Antonio, Texas, United States, 78229 | |
San Antonio Gastroenterology | |
San Antonio, Texas, United States, 78229 | |
Digestive Health Specialists of Tyler | |
Tyler, Texas, United States, 75701 | |
Local Institution - 125 | |
Tyler, Texas, United States, 75701 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 | |
United States, Virginia | |
University of Virginia | |
Charlottesville, Virginia, United States, 22903 | |
Gastroenterology, LTD | |
Virginia Beach, Virginia, United States, 23454 | |
United States, Washington | |
Local Institution - 139 | |
Seattle, Washington, United States, 98104 | |
University of Washington School of Medicine | |
Seattle, Washington, United States, 98104 | |
Argentina | |
Hospital Italiano | |
Buenos Aires, Argentina, C1181ACH | |
Instituto Medico CER | |
Quilmes, Argentina, B1878DVB | |
Local Institution - 308 | |
Quilmes, Argentina, B1878DVB | |
Instituto Medico de la Fundacion Estudios Clinicos | |
Rosario, Argentina, 2000 | |
Australia, New South Wales | |
Royal Prince Alfred Hospital | |
Camperdown, New South Wales, Australia, 2050 | |
Australia, Queensland | |
Princess Alexandra Hospital | |
Woolloongabba, Queensland, Australia, 4102 | |
Australia, South Australia | |
Local Institution - 158 | |
Adelaide, South Australia, Australia, 5000 | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Victoria | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
Local Institution - 151 | |
Melbourne, Victoria, Australia, 3181 | |
Austria | |
Medical University Vienna | |
Vienna, Austria, 1090 | |
Belarus | |
Gomel Regional Clinical Hospital | |
Gomel, Belarus, 246029 | |
City Clinical Hospital No 10 | |
Minsk, Belarus, 220096 | |
Vitebsk Regional Clinical Hospital | |
Vitebsk, Belarus, 210037 | |
Belgium | |
Imeldaziekenhuis | |
Bonheiden, Belgium, 2820 | |
AZ Maria Middelares | |
Gent, Belgium, 9000 | |
Universitair Ziekenhuis Gent | |
Gent, Belgium, 9000 | |
UZ Leuven | |
Leuven, Belgium, 3000 | |
CHC - Clinique St-Jospeh | |
Liege, Belgium, 4000 | |
Local Institution - 604 | |
Liege, Belgium, 4000 | |
Bulgaria | |
MC Rusemed ltd. | |
Ruse, Bulgaria, 7013 | |
NMTH "Tsar Boris III" | |
Sofia, Bulgaria, 1233 | |
MHAT "Lyulin", EAD | |
Sofia, Bulgaria, 1336 | |
"City Clinic UMHAC" EOOD | |
Sofia, Bulgaria, 1407 | |
Local Institution - 453 | |
Sofia, Bulgaria, 1407 | |
MHAT 'Tokuda Hospital Sofia', EAD | |
Sofia, Bulgaria, 1407 | |
UMHAT "Sv. Ivan Rilski", EAD | |
Sofia, Bulgaria, 1431 | |
UMHAT 'Tsaritsa Yoanna - ISUL', EAD | |
Sofia, Bulgaria, 1527 | |
Fourth MHAT - Sofia EAD | |
Sofia, Bulgaria, 1606 | |
Local Institution - 461 | |
Stara Zagora, Bulgaria, 6000 | |
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD | |
Stara Zagora, Bulgaria, 6000 | |
MHAT 'Sv. Marina', EAD | |
Varna, Bulgaria, 9010 | |
MC Medica Plus | |
Veliko Tarnovo, Bulgaria, 5000 | |
Canada, British Columbia | |
Local Institution - 258 | |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Vancouver General Hospital | |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Canada, Ontario | |
Viable Clinical Research - Lindsay | |
Lindsay, Ontario, Canada, K9V 5G6 | |
LHSC - University Hospital | |
London, Ontario, Canada, N6A 5A5 | |
Local Institution - 256 | |
London, Ontario, Canada, N6A 5A5 | |
LHSC - Victoria Hospital | |
London, Ontario, Canada, N6A 5W9 | |
Humber River Hospital | |
Toronto, Ontario, Canada, M3M 0B2 | |
Toronto Liver Centre | |
Toronto, Ontario, Canada, M6H 3M1 | |
Toronto Digestive Disease Associates, Inc. | |
Vaughan, Ontario, Canada, L4L 4Y7 | |
Canada, Quebec | |
The Ottawa Hospital - General Campus | |
Ottawa, Quebec, Canada, K1H 8L6 | |
Croatia | |
Clinical Hospital Centre Osijek | |
Osijek, Croatia, 31000 | |
Clinical Hospital Centre Rijeka | |
Rijeka, Croatia, 51000 | |
Czechia | |
Vojenska nemocnice Brno | |
Brno, Czechia, 63600 | |
Hepato-Gastroenterologie HK, s.r.o. | |
Hradec Kralove, Czechia, 50012 | |
GASTRO JeKa s.r.o. | |
Klatovy, Czechia, 399 01 | |
Local Institution - 342 | |
Klatovy, Czechia, 399 01 | |
Gregar s.r.o. | |
Olomouc, Czechia, 779 00 | |
PreventaMed | |
Olomouc, Czechia, 77900 | |
ISCARE, a.s. | |
Prague 9, Czechia, 190 00 | |
Institut klinicke a experimentalni mediciny | |
Praha 4, Czechia, 14021 | |
Local Institution - 335 | |
Slany, Czechia, 27401 | |
Nemocnice Slany | |
Slany, Czechia, 27401 | |
Georgia | |
Local Institution - 626 | |
Tbilisi, Georgia, 0112 | |
LTD Research Institute of Clinical Medicine | |
Tbilisi, Georgia, 0112 | |
LLC Vivamedi | |
Tbilisi, Georgia, 0131 | |
Local Institution - 630 | |
Tbilisi, Georgia, 0131 | |
Local Institution - 627 | |
Tbilisi, Georgia, 0160 | |
LTD Academician N.Kipshidze Central University Clinic | |
Tbilisi, Georgia, 0160 | |
LTD Coloproctological Center | |
Tbilisi, Georgia, 0160 | |
Germany | |
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | |
Berlin, Germany, 12200 | |
Charite - Campus Virchow-Klinikum | |
Berlin, Germany, 13353 | |
Local Institution - 525 | |
Berlin, Germany, 13353 | |
DRK Kliniken Berlin Westend | |
Berlin, Germany, 14050 | |
Local Institution - 533 | |
Berlin, Germany, 14050 | |
Medizinisches Versorgungszentrum Dachau | |
Dachau, Germany, 85221 | |
Local Institution - 534 | |
Dresden, Germany, 1307 | |
Universitaetsklinikum Carl Gustav Carus TU Dresden | |
Dresden, Germany, 1307 | |
Klinikum der Johann Wolfgang Goethe-Universitaet | |
Frankfurt, Germany, 60590 | |
Crohn Colitis Centrum Rhein Main | |
Frankfurt, Germany, 60594 | |
Local Institution - 545 | |
Frankfurt, Germany, 60594 | |
Asklepios Klinik Hamburg | |
Hamburg, Germany, 22559 | |
Universitaetsklinikum Koeln | |
Koeln, Germany, 50937 | |
EUGASTRO GmbH | |
Leipzig, Germany, 4103 | |
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | |
Luebeck, Germany, 23538 | |
Local Institution - 530 | |
Mainz, Germany, 55131 | |
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | |
Mainz, Germany, 55131 | |
Greece | |
General Hospital of Athens Evangelismos | |
Athens, Greece, 10676 | |
Local Institution - 643 | |
Athens, Greece, 10676 | |
Hungary | |
DRC Gyogyszervizsgalo Kozpont Kft | |
Balatonfured, Hungary, 8230 | |
Local Institution - 816 | |
Balatonfured, Hungary, 8230 | |
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz | |
Bekescsaba, Hungary, 5600 | |
Local Institution - 815 | |
Bekescsaba, Hungary, 5600 | |
Magyar Honvedseg Egeszsegugyi Kozpont | |
Budapest, Hungary, 1062 | |
Local Institution - 807 | |
Budapest, Hungary, 1088 | |
Semmelweis Egyetem | |
Budapest, Hungary, 1088 | |
Pannonia Maganorvosi Centrum | |
Budapest, Hungary, 1136 | |
Debreceni Egyetem Klinikai Kozpont | |
Debrecen, Hungary, 4032 | |
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza | |
Gyula, Hungary, 5700 | |
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont | |
Letavertes, Hungary, 4281 | |
Mohacsi Korhaz | |
Mohacs, Hungary, 7700 | |
Clinfan Szolgaltato Kft | |
Szekszard, Hungary, 7100 | |
Israel | |
Shaare Zedek Medical Center | |
Jerusalem, Israel, 91120 | |
Meir Medical Center | |
Kfar-Saba, Israel, 44281 | |
Chaim Sheba Medical Center | |
Ramat Gan, Israel, 52621 | |
Kaplan Medical Center | |
Rechovot, Israel, 76100 | |
Local Institution - 504 | |
Tel Aviv, Israel, 64239 | |
Tel Aviv Sourasky Medical Center | |
Tel Aviv, Israel, 64239 | |
Italy | |
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi | |
Bologna, Italy, 40138 | |
Local Institution - 571 | |
Bologna, Italy, 40138 | |
Azienda Ospedaliera Universitaria Careggi | |
Firenze, Italy, 50134 | |
Azienda Ospedaliero Universitaria San Martino | |
Genova, Italy, 16132 | |
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) | |
Milano, Italy, 20157 | |
A.O.U. Policlinico di Modena | |
Modena, Italy, 41124 | |
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) | |
Monza, Italy, 20900 | |
Azienda Ospedaliera Universitaria "Federico II" | |
Napoli, Italy, 80131 | |
Azienda Ospedaliero Universitaria Pisana | |
Pisa, Italy, 56124 | |
Complesso Integrato Columbus | |
Roma, Italy, 00168 | |
Local Institution - 561 | |
Roma, Italy, 00168 | |
Istituto Clinico Humanitas | |
Rozzano, Italy, 20089 | |
Local Institution - 563 | |
Rozzano, Italy, 20089 | |
IRCCS Ospedale Casa Sollievo della Sofferenza | |
San Giovanni Rotondo, Italy, 71013 | |
Korea, Republic of | |
Inje University Haeundae Paik Hospital | |
Busan, Korea, Republic of, 612-030 | |
Yeungnam University Hospital | |
Daegu, Korea, Republic of, 42415 | |
Hanyang Univerisy Guri Hospital | |
Guri-si, Korea, Republic of, 471-701 | |
CHA Bundang Medical Center CHA University | |
Seongnam-si,, Korea, Republic of, 13496 | |
Seoul National University Bundang Hospital | |
Seongnam-si, Korea, Republic of, 13620 | |
Kyung Hee University Hospital | |
Seoul, Korea, Republic of, 02447 | |
Local Institution - 351 | |
Seoul, Korea, Republic of, 06351 | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135-710 | |
Korea University Anam Hospital | |
Seoul, Korea, Republic of, 136-705 | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 3080 | |
Kangbuk Samsung Hospital | |
Seoul, Korea, Republic of, 3181 | |
Asan Medical Center | |
Seoul, Korea, Republic of, 5505 | |
Ewha Womans University Mokdong Hospital | |
Seoul, Korea, Republic of, 7985 | |
The Catholic University of Korea, St. Vincent's Hospital | |
Suwon-si, Korea, Republic of, 16247 | |
Yonsei University Wonju Severance Christian Hospital | |
Wonju-si, Korea, Republic of, 26426 | |
Latvia | |
Local Institution - 585 | |
Riga, Latvia, LV-1002 | |
P. Stradins Clinical University Hospital | |
Riga, Latvia, LV-1002 | |
Moldova, Republic of | |
"Sfanta Treime" Clinical Municipal Hospital | |
Chisinau, Moldova, Republic of, MD-2068 | |
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery | |
Chisinau, Moldova, Republic of, MD2005 | |
"Sf. Arhanghel Mihail" Municipal Clinical Hospital | |
Chisinau, Moldova, Republic of, MD2025 | |
Republican Clinical Hospital | |
Chisinau, Moldova, Republic of, MD2025 | |
Netherlands | |
Vrije Universiteit Medisch Centrum (VUMC) | |
Amsterdam, Netherlands, 1081 HV | |
Academisch Medisch Centrum | |
Amsterdam, Netherlands, 1105 AZ | |
Universitair Medisch Centrum Groningen (UMCG) | |
Groningen, Netherlands, 9700 RB | |
Zuyderland Medisch Centrum - Sittard-Geleen | |
Sittard-Geleen, Netherlands, 6162 BG | |
ETZ Elisabeth | |
Tilburg, Netherlands, 5022 GC | |
New Zealand | |
Dunedin Public Hospital | |
Dunedin, New Zealand, 9016 | |
Local Institution - 877 | |
Dunedin, New Zealand, 9016 | |
Poland | |
Clinsante S.C. Osrodek Badan Klinicznych | |
Bydgoszcz, Poland, 85-794 | |
Local Institution - 407 | |
Chorzow, Poland, 41-500 | |
Specjalistyczna Przychodnia Lekarska Medicus | |
Chorzow, Poland, 41-500 | |
Niepubliczny Zaklad Opieki Zdrowotnej Inter-Med | |
Czestochowa, Poland, 42-217 | |
GLOBE Clinical Research Sp. z o.o. LLC | |
Klodzko, Poland, 57-300 | |
PLEJADY Sp. z o.o. (LLC) Medical Centre | |
Krakow, Poland, 30-363 | |
Healthcare Center Orkan Med Stec Michalska Spolka Jawna | |
Ksawerow, Poland, 95-054 | |
Santa Familia Centrum Badan, Profilaktyki i Leczenia | |
Lodz, Poland, 90-302 | |
KO-MED Centra Kliniczne Lublin II | |
Lublin, Poland, 20-362 | |
Local Institution - 387 | |
Piotrkow Trybunalski, Poland, 97-300 | |
Trialmed Llc | |
Piotrkow Trybunalski, Poland, 97-300 | |
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski | |
Sopot, Poland, 81-756 | |
KO-MED Centra Kliniczne Staszow | |
Staszow, Poland, 28-200 | |
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe | |
Torun, Poland, 87-100 | |
MDM Healthcare Centre | |
Warsaw, Poland, 00-632 | |
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice | |
Wierzchoslawice, Poland, 33-122 | |
LexMedica Osrodek Badan Klinicznych | |
Wroclaw, Poland, 53-114 | |
Local Institution - 419 | |
Wroclaw, Poland, 53-114 | |
Romania | |
Bacau County Emergency Hospital, Department of Gastroenterology | |
Bacau, Romania, 600114 | |
Hyperclinica MedLife Grivita | |
Bucharest, Romania, 010719 | |
Bucharest University Emergency Hospital, Department of Internal Medicine II | |
Bucharest, Romania, 050098 | |
Local Institution - 673 | |
Bucharest, Romania, 050098 | |
TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy | |
Cluj-Napoca, Romania, 400132 | |
Craiova County Emergency Clinical Hospital | |
Craiova, Romania, 200642 | |
"Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology | |
Timisoara, Romania, 300723 | |
Russian Federation | |
Local Institution - 724 | |
Barnaul, Russian Federation, 656043 | |
Multidisciplinary Medical Clinic "Anthurium" | |
Barnaul, Russian Federation, 656043 | |
Irkutsk State Medical Academy of Continuing Education | |
Irkutsk, Russian Federation, 664049 | |
Local Institution - 726 | |
Irkutsk, Russian Federation, 664049 | |
Local Institution - 709 | |
Kazan, Russian Federation, 420012 | |
SBEI HPE "Kazan State Medical University" of the MoH of the RF | |
Kazan, Russian Federation, 420012 | |
Local Institution - 703 | |
Nizhniy Novgorod, Russian Federation, 603126 | |
SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko" | |
Nizhniy Novgorod, Russian Federation, 603126 | |
Local Institution - 706 | |
Novosibirsk, Russian Federation, 630091 | |
SBEIHPE Novosibirsk State Medical University | |
Novosibirsk, Russian Federation, 630091 | |
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS | |
Novosibirsk, Russian Federation, 630117 | |
Local Institution - 707 | |
Novosibirsk, Russian Federation, 630117 | |
BHI of Omsk region "Clinical Oncology Dispensary" | |
Omsk, Russian Federation, 644013 | |
Local Institution - 713 | |
Omsk, Russian Federation, 644013 | |
Local Institution - 711 | |
Rostov-on-Don, Russian Federation, 344022 | |
SBEI HPE Rostov State Medical University of the MoH of the RF | |
Rostov-on-Don, Russian Federation, 344022 | |
City Clinical Hospital No 31 - St. Petersburg | |
Saint Petersburg, Russian Federation, 197110 | |
Local Institution - 727 | |
Saint Petersburg, Russian Federation, 197110 | |
FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia | |
Saint-Petersburg, Russian Federation, 194044 | |
Local Institution - 717 | |
Saint-Petersburg, Russian Federation, 194044 | |
Local Institution - 722 | |
Saint-Petersburg, Russian Federation, 196247 | |
SPb SBIH City Hospital # 26 | |
Saint-Petersburg, Russian Federation, 196247 | |
Local Institution - 716 | |
Saint-Petersburg, Russian Federation, 197022 | |
Pavlov First Saint Petersburg State Medical University | |
Saint-Petersburg, Russian Federation, 197022 | |
Local Institution - 728 | |
Samara, Russian Federation, 0 | |
Local Institution - 720 | |
Samara, Russian Federation, 443011 | |
Private Educational Institution of Higher Education "Medical University "REAVIZ" | |
Samara, Russian Federation, 443011 | |
LLC Medical Company Hepatologist | |
Samara, Russian Federation | |
FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine" | |
St. Petersburg, Russian Federation, 194044 | |
Local Institution - 705 | |
St. Petersburg, Russian Federation, 194044 | |
Local Institution - 712 | |
St.Petersburg, Russian Federation, 193312 | |
SPb SBIH Alexandrovskaya City Hospital | |
St.Petersburg, Russian Federation, 193312 | |
SBEI HPE "Stavropol State Medical Academy" MoH of RF | |
Stavropol, Russian Federation, 355017 | |
Serbia | |
Clinical Hospital Center Zvezdara Clinic of Internal Diseases | |
Belgrade, Serbia, 11000 | |
Local Institution - 688 | |
Belgrade, Serbia, 11000 | |
Military Medical Academy | |
Belgrade, Serbia, 11000 | |
Clinical Center Bezanijska Kosa | |
Belgrade, Serbia, 11080 | |
Clinical Hospital Center Zemun Department of Gastroenterology | |
Belgrade, Serbia, 11080 | |
Clinical Center Kragujevac | |
Kragujevac, Serbia, 34000 | |
General Hospital Djordje Jovanovic Zrenjanin | |
Zrenjanin, Serbia, 23 000 | |
Slovakia | |
Fakultna nemocnica s poliklinikou F.D. Roosevelta | |
Banska Bystrica, Slovakia, 97517 | |
Alian s.r.o. | |
Bardejov, Slovakia, 08501 | |
Gastromedic s.r.o. | |
Nove Zamky, Slovakia, 94002 | |
GASTRO I., s.r.o. | |
Presov, Slovakia, 080 01 | |
South Africa | |
Dr MJ Prins Practice | |
Cape Town, South Africa, 7500 | |
Endocare Research | |
Cape Town, South Africa, 7646 | |
Emmed Research | |
Pretoria, South Africa, 2 | |
Ukraine | |
RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU | |
Chernivtsi, Ukraine, 58002 | |
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital | |
Dnipropetrovsk, Ukraine, 49027 | |
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases | |
Dnipropetrovsk, Ukraine, 49074 | |
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU | |
Ivano-Frankivsk, Ukraine, 76018 | |
CI of PH Kharkiv CCH #2 | |
Kharkiv, Ukraine, 61037 | |
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine | |
Kharkiv, Ukraine, 61039 | |
Ok Clinic Medical Center within International Institute of Clinical Trials, LLC | |
Kyiv, Ukraine, 02175 | |
Kyiv Regional Hospital #2 | |
Kyiv, Ukraine, 04053 | |
Local Institution - 984 | |
Kyiv, Ukraine, 04053 | |
SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU | |
Kyiv, Ukraine, 04053 | |
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE | |
Kyiv, Ukraine, 04201 | |
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU | |
Kyiv, Ukraine, 1030 | |
Lviv Regional Clinical Hospital D Halytskyi Lviv NMU | |
Lviv, Ukraine, 79010 | |
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU | |
Lviv, Ukraine, 79059 | |
CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU | |
Sumy, Ukraine, 40021 | |
Local Institution - 988 | |
Sumy, Ukraine, 40031 | |
Sumy Regional Clinical Hospital | |
Sumy, Ukraine, 40031 | |
Local Institution - 978 | |
Vinnytsia, Ukraine, 21005 | |
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War | |
Vinnytsia, Ukraine, 21005 | |
Local Institution - 957 | |
Vinnytsia, Ukraine, 21018 | |
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU | |
Vinnytsia, Ukraine, 21018 | |
Local Institution - 981 | |
Vinnytsia, Ukraine, 21029 | |
Vinnytsia M.I. Pyrohov National Medical University | |
Vinnytsia, Ukraine, 21029 | |
City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya | |
Zaporizhia, Ukraine, 69000 | |
CI City Hospital #1 | |
Zaporizhia, Ukraine, 69104 | |
CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU | |
Zaporizhzhia, Ukraine, 69065 | |
Local Institution - 961 | |
Zaporizhzhia, Ukraine, 69065 | |
Zaporizhia Regional Clinical Hospital | |
Zaporizhzhia, Ukraine, 69600 | |
Central District Hospital under Zhytomyr District Council | |
Zhytomyr, Ukraine, 12430 | |
Local Institution - 989 | |
Zhytomyr, Ukraine, 12430 | |
United Kingdom | |
Local Institution - 236 | |
London, Greater London, United Kingdom, E11 1NR | |
Royal Devon and Exeter Hospital (Wonford) | |
Exeter, United Kingdom, EX2 5DW | |
Whipps Cross University Hospital | |
London, United Kingdom, E11 1NR | |
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital | |
London, United Kingdom, SE1 9RT | |
Royal Shrewsbury Hospital | |
Shrewsbury, United Kingdom, SY38XQ |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT02531126 |
Other Study ID Numbers: |
RPC01-3102 2015-001600-64 ( EudraCT Number ) U1111-1218-0284 ( Registry Identifier: WHO ) |
First Posted: | August 24, 2015 Key Record Dates |
Last Update Posted: | January 13, 2023 |
Last Verified: | January 2023 |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases |
Pathologic Processes Inflammatory Bowel Diseases Ozanimod Sphingosine 1 Phosphate Receptor Modulators Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |