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Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435992
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: RPC1063 Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
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 17, 2015
Estimated Primary Completion Date : June 27, 2020
Estimated Study Completion Date : March 28, 2021

Resource links provided by the National Library of Medicine


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



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



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   12 Years 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

Information from the National Library of Medicine

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): NCT02435992


Contacts
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Contact: Celgene True North Study True North Study 1-844-266-9299 truenorth@quintiles.com

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Locations
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United States, Arizona
Arizona Digestive Health Completed
Sun City, Arizona, United States, 85351
Adobe Clinical Research LLC Recruiting
Tucson, Arizona, United States, 85712
United States, Arkansas
Arkansas Gastroenterology, P.A. Recruiting
North Little Rock, Arkansas, United States, 72117
United States, California
Anaheim Clinical Trials Completed
Anaheim, California, United States, 92801
Aurora Care Clinic Recruiting
Costa Mesa, California, United States, 92627
Valley View Internal Medicine Active, not recruiting
Garden Grove, California, United States, 92843
Davita Clinical Trials, LLC Completed
Huntington Beach, California, United States, 92646
University of California San Diego Medical Center Completed
La Jolla, California, United States, 92037
OM Research Recruiting
Lancaster, California, United States, 93534
University of Southern California - Keck School of Medicine Completed
Los Angeles, California, United States, 90033
Southern California Research Institute Medical Group, Inc. Active, not recruiting
Los Angeles, California, United States, 90045
Gastrointestinal Biosciences Active, not recruiting
Los Angeles, California, United States, 90067
UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Facey Medical Foundation (Parent) Recruiting
Mission Hills, California, United States, 91345
Alliance Clinical Research, LLC Completed
Oceanside, California, United States, 92056-4497
Medical Associates Research Group, Inc. Recruiting
San Diego, California, United States, 92123
University of California at San Francisco (PARENT) Recruiting
San Francisco, California, United States, 94115
United States, Connecticut
Medical Research Center of Connecticut, LLC Completed
Hamden, Connecticut, United States, 06518
United States, Florida
Gastro Florida Recruiting
Clearwater, Florida, United States, 33756-3839
Clinical Research of West Florida Inc - Clearwater Recruiting
Clearwater, Florida, United States, 33765
Advanced Pharma Research, Inc Recruiting
Delray Beach, Florida, United States, 33445
Universal Axon Clinical Research Recruiting
Doral, Florida, United States, 33166
Dolphin Medical Research Completed
Doral, Florida, United States, 33172
South Florida Clinical Trials Not yet recruiting
Hialeah, Florida, United States, 33016
Florida Center for Gastroenterology Recruiting
Largo, Florida, United States, 33777
City Medical Group Recruiting
Miami, Florida, United States, 33126
Advanced Clincial Research Recruiting
Miami, Florida, United States, 33134
Advanced Clinical Research of Miami Completed
Miami, Florida, United States, 33155
Regenerate Clinical Trials Completed
Miami, Florida, United States, 33155
Advanced Research for Health Improvement Recruiting
Naples, Florida, United States, 34109
Advanced Research Institute, Inc. Completed
New Port Richey, Florida, United States, 34653
NSB Research Recruiting
New Smyrna Beach, Florida, United States, 32168
Harmony Clinical Research Recruiting
North Miami Beach, Florida, United States, 33162
Med-Care Research Completed
North Miami Beach, Florida, United States, 33162
Center For Digestive Health Recruiting
Orlando, Florida, United States, 32803
IMIC, Inc. Recruiting
Palmetto Bay, Florida, United States, 33157
DBC Research, Corp Recruiting
Pembroke Pines, Florida, United States, 33029
Theia Clinical Research, LLC Recruiting
Pinellas Park, Florida, United States, 33781
Florida Medical Clinic, P.A. Recruiting
Zephyrhills, Florida, United States, 33613
United States, Georgia
Atlanta Gastroenterology Associates LLC Recruiting
Atlanta, Georgia, United States, 30342
Gastrointestinal Specialists of Georgia, PC Completed
Marietta, Georgia, United States, 30060
United States, Idaho
Grand Teton Research Group, PLLC Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Northwestern University Feinberg Sch of Medicine Division of Gastroenterology Recruiting
Chicago, Illinois, United States, 60611
University of Chicago Medical Center Active, not recruiting
Chicago, Illinois, United States, 60637-1447
DM Clinical Research Recruiting
Oak Lawn, Illinois, United States, 60453-3767
Carle Foundation Hospital Completed
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University Hospital Completed
Indianapolis, Indiana, United States, 46202
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health Completed
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Kentucky Medical Center Completed
Lexington, Kentucky, United States, 40504
University of Louisville Completed
Louisville, Kentucky, United States, 40202
United States, Louisiana
Gastroenterology Associates, LLC Recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
University of Maryland Medical Group Recruiting
Baltimore, Maryland, United States, 21201
Woodholme Gastroenterology Recruiting
Baltimore, Maryland, United States, 21209
Johns Hopkins Clinical Research Network Recruiting
Baltimore, Maryland, United States, 21287
Chevy Chase Clinical Research Recruiting
Chevy Chase, Maryland, United States, 20815
Gastro Center of Maryland Recruiting
Columbia, Maryland, United States, 21045
Charm City Research Group Completed
Towson, Maryland, United States, 21204
United States, Massachusetts
Boston Medical Center Completed
Boston, Massachusetts, United States, 02118
Commonwealth Clinical Studies, PLLC. Completed
Brockton, Massachusetts, United States, 02302
Community Clinical Research Network Completed
Marlborough, Massachusetts, United States, 01752
United States, Michigan
University of Michigan Health System Completed
Ann Arbor, Michigan, United States, 48109
Center For Digestive Health Completed
Troy, Michigan, United States, 48098
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Ehrhardt Clinical Research, LLC Completed
Belton, Missouri, United States, 64012
Clinical Research Professionals, LLC - De Paul Medical Dr Recruiting
Bridgeton, Missouri, United States, 63044
Washington University Completed
Saint Louis, Missouri, United States, 63110
Clinical Research Professionals LLC - The Pines Court Completed
Saint Louis, Missouri, United States, 63141
Clinical Research Professionals, LLC - Olde Cabin Rd Recruiting
Saint Louis, Missouri, United States, 63141
Mercy Research Completed
Springfield, Missouri, United States, 65806
United States, New Hampshire
Mary Hitchcock Memorial Hospital Recruiting
Lebanon, New Hampshire, United States, 07756
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
NY Scientific Recruiting
Brooklyn, New York, United States, 11235
Long Island Clinical Research Associates Completed
Great Neck, New York, United States, 11021
Icahn School of Medicine Mount Sinai Beth Isreal Completed
New York, New York, United States, 10003
Concord Medical Group PRIME Recruiting
New York, New York, United States, 10016
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Mount Sinai - PRIME Recruiting
New York, New York, United States, 10029
United States, North Carolina
Asheville Gastroenterology Associates, P.A. Recruiting
Asheville, North Carolina, United States, 28801
University of North Carolina at Chapel Hill Completed
Chapel Hill, North Carolina, United States, 27599-7305
Carolinas HealthCare System Digestive Health Completed
Charlotte, North Carolina, United States, 28204
East Carolina Gastroenterology, PA Recruiting
Jacksonville, North Carolina, United States, 28546
Kinston Medical Specialists, PA Completed
Kinston, North Carolina, United States, 28501
PMG Research of Rocky Mount, LLC Recruiting
Rocky Mount, North Carolina, United States, 27804
United States, Ohio
UC Health Clinical Trials Office Recruiting
Cincinnati, Ohio, United States, 45206
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Ohio State University Clinical Trials Management Office Completed
Columbus, Ohio, United States, 43210
Clinical Inquest Center Ltd Recruiting
Springfield, Ohio, United States, 45504
Clinical Inquest Center Ltd Active, not recruiting
Springfield, Ohio, United States, 45504
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Digestive Disease Specialists Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104-4206
United States, South Carolina
Consultants in Gastroenterology, PA Recruiting
Columbia, South Carolina, United States, 29203
Gastroenterology Associates of Orangeburg Recruiting
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Gastro One Completed
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor Research Institute Completed
Dallas, Texas, United States, 75246-1613
Brooke-Army Medical Center Completed
Fort Sam Houston, Texas, United States, 78234
Ventavia Research Group, LLC Completed
Fort Worth, Texas, United States, 76104
Gulf Coast Research Group LLC Recruiting
Houston, Texas, United States, 77004
The Methodist Hospital Research Institute Active, not recruiting
Houston, Texas, United States, 77030
Houston Endoscopy and Research Center Recruiting
Houston, Texas, United States, 77079
Gastroenterology Research of San Antonio, LLC Completed
San Antonio, Texas, United States, 78229
San Antonio Gastroenterology Recruiting
San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultants - Southlake Recruiting
Southlake, Texas, United States, 76092
Spring Gastroenterology Active, not recruiting
Spring, Texas, United States, 77379
Digestive Health Specialists of Tyler Recruiting
Tyler, Texas, United States, 75701
United States, Utah
University of Utah Completed
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Completed
Charlottesville, Virginia, United States, 22908
Gastroenterology Associates of Tidewater Completed
Chesapeake, Virginia, United States, 23320
Gastroenterology, LTD Completed
Virginia Beach, Virginia, United States, 23454
United States, Washington
Benaroya Research Institute at Virginia Mason Recruiting
Seattle, Washington, United States, 98101
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98109
Argentina
Hospital Italiano Completed
Buenos Aires, Argentina, C1181ACH
Instituto DAMIC Fundacion Rusculleda Completed
Cordoba, Argentina, X5003DCE
Hospital Italiano de La Plata Completed
La Plata, Argentina, 01900
Instituto Medico CER Recruiting
Quilmes, Argentina, B1878DVB
Instituto Medico de la Fundacion Estudios Clinicos Completed
Rosario, Argentina, 2000
Australia, New South Wales
Centre For Digestive Diseases Completed
Five Dock, New South Wales, Australia, 2046
Australia, Queensland
Mater Hospital Brisbane Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital Active, not recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital Active, not recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Cabrini Hospital Malvern Completed
Malvern, Victoria, Australia, 3144
The Alfred Hospital Active, not recruiting
Melbourne, Victoria, Australia, 3004
Australia
Monash Medical Centre Clayton Completed
Bentleigh East, Australia, 3165
Royal Prince Alfred Hospital Completed
Camperdown, Australia, 2050
Nepean Hospital Recruiting
Kingswood, NSW, Australia, 2751
Austria
Medical University Vienna Recruiting
Vienna, Austria, 1090
Belarus
Gomel Regional Clinical Hospital Recruiting
Gomel, Belarus, 246029
City Clinical Hospital No 10 Recruiting
Minsk, Belarus, 220096
Vitebsk Regional Clinical Hospital Recruiting
Vitebsk, Belarus, 210037
Belgium
Imeldaziekenhuis Recruiting
Bonheiden, Belgium, 2820
AZ Maria Middelares Recruiting
Gent, Belgium, 9000
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
UZ Leuven Recruiting
Leuven, Belgium, 3000
CHC - Clinique St-Jospeh Recruiting
Liege, Belgium, 4000
Bulgaria
Medical Centre "Asklepii", OOD Completed
Dupnitsa, Bulgaria, 2600
UMHAT 'Dr. Georgi Stranski', EAD Completed
Pleven, Bulgaria, 5800
UMHAT "Kaspela", EOOD Recruiting
Plovdiv, Bulgaria, 4002
MC Rusemed ltd. Recruiting
Ruse, Bulgaria, 7013
NMTH "Tsar Boris III" Recruiting
Sofia, Bulgaria, 1233
MHAT "Lyulin", EAD Recruiting
Sofia, Bulgaria, 1336
City Clinic UMHAC EOOD Recruiting
Sofia, Bulgaria, 1407
MHAT 'Tokuda Hospital Sofia', EAD Recruiting
Sofia, Bulgaria, 1407
UMHAT 'Tsaritsa Yoanna - ISUL', EAD Recruiting
Sofia, Bulgaria, 1527
Fourth MHAT - Sofia EAD Recruiting
Sofia, Bulgaria, 1606
UMHAT 'Sveta Anna' AD Completed
Sofia, Bulgaria, 1750
UMHAT "SofiaMed", OOD Completed
Sofia, Bulgaria, 1797
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD Recruiting
Stara Zagora, Bulgaria, 6000
MHAT 'Sv. Marina', EAD Recruiting
Varna, Bulgaria, 9010
MC Medica Plus Recruiting
Veliko Tarnovo, Bulgaria, 5000
Canada, British Columbia
Vancouver General Hospital Completed
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Brandon Medical Arts Clinic Completed
Brandon, Manitoba, Canada, R7A 0N7
Canada, Ontario
Viable Clinical Research - Lindsay Active, not recruiting
Lindsay, Ontario, Canada, K9V 5G6
LHSC - University Hospital Completed
London, Ontario, Canada, N6A 5A5
LHSC - Victoria Hospital Completed
London, Ontario, Canada, N6A 5W9
Humber River Hospital Recruiting
Toronto, Ontario, Canada, M3M 0B2
Mount Sinai Hospital Active, not recruiting
Toronto, Ontario, Canada, M5T 3L9
Toronto Liver Centre Completed
Toronto, Ontario, Canada, M6H 3M1
Toronto Digestive Disease Associates, Inc. Completed
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
The Ottawa Hospital - General Campus Completed
Ottawa, Quebec, Canada, K1H 8L6
CHUS - Hôpital Fleurimont Completed
Sherbrooke, Quebec, Canada, J1H5N4
Croatia
Clinical Hospital Center Osijek Recruiting
Osijek, Croatia, 31000
Clinical Hospital Centre Rijeka Recruiting
Rijeka, Croatia, 51000
Clinical Hospital "Sveti Duh", Clinic of Internal Diseases Completed
Zagreb, Croatia, 10000
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases Completed
Zagreb, Croatia, 10000
Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology Completed
Zagreb, Croatia, 10000
Czechia
Vojenska nemocnice Brno Recruiting
Brno, Czechia, 63600
Hepato-Gastroenterologie HK, s.r.o. Recruiting
Hradec Kralove, Czechia, 50012
GASTRO JeKa s.r.o. Recruiting
Klatovy, Czechia, 399 01
Gregar s.r.o. Recruiting
Olomouc, Czechia, 779 00
PreventaMed Recruiting
Olomouc, Czechia, 77900
Institut klinicke a experimentalni mediciny Recruiting
Praha 4, Czechia, 14021
Thomayerova nemocnice Recruiting
Praha 4, Czechia, 14059
IBD Centrum/ISCARE IVF a.s. Recruiting
Praha 7, Czechia, 17004
Nemocnice Slany Recruiting
Slany, Czechia, 274 01
Georgia
LTD Research Institute of Clinical Medicine Recruiting
Tbilisi, Georgia, 0112
LLC Vivamedi Recruiting
Tbilisi, Georgia, 0131
LTD Academician N.Kipshidze Central University Clinic Recruiting
Tbilisi, Georgia, 0160
LTD Aversi Clinic Completed
Tbilisi, Georgia, 0160
LTD Coloproctological Center Recruiting
Tbilisi, Georgia, 0160
Germany
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Charite - Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
DRK Kliniken Berlin Westend Recruiting
Berlin, Germany, 14050
Medical Care Unit Dachau Recruiting
Dachau, Germany, 85221
Universitaetsklinikum Carl Gustav Carus TU Dresden Recruiting
Dresden, Germany, 01307
Klinikum der Johann Wolfgang Goethe-Universitaet Recruiting
Frankfurt, Germany, 60590
Crohn Colitis Centrum Rhein Main Recruiting
Frankfurt, Germany, 60594
Universitaetsklinikum Freiburg Completed
Freiburg, Germany, 79106
Universitaetsklinikum Hamburg-Eppendorf Active, not recruiting
Hamburg, Germany, 20426
Asklepios Klinik Hamburg Recruiting
Hamburg, Germany, 22559
Medizinische Hochschule Hannover Completed
Hannover, Germany, 30625
Universitaetsklinikum Koeln Recruiting
Koeln, Germany, 50937
EUGASTRO GmbH Recruiting
Leipzig, Germany, 4103
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck Completed
Luebeck, Germany, 23538
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Recruiting
Mainz, Germany, 55131
Universitatsklinikum Ulm Recruiting
Ulm, Germany, 89081
Greece
Laiko General Hospital of Athens Recruiting
Athens, Greece, 11 527
University General Hospital of Heraklion Recruiting
Heraklion, Greece, 715 00
University General Hospital of Larissa Not yet recruiting
Larissa Thessaly, Greece, 41110
General Hospital of Thessaloniki Hippokration Recruiting
Thessaloniki, Greece, 54642
424th Army General Hospital Recruiting
Thessaloniki, Greece, 56429
Hungary
DRC Gyogyszervizsgalo Kozpont Kft Recruiting
Balatonfured, Hungary, 8230
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz Recruiting
Bekescsaba, Hungary, 5600
Obudai Egeszsegugyi Centrum Kft. Completed
Budapest, Hungary, 1036
Magyar Honvedseg Egeszsegugyi Kozpont Recruiting
Budapest, Hungary, 1062
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1083
Pannonia Maganorvosi Centrum Recruiting
Budapest, Hungary, 1136
Szent Margit Korhaz Recruiting
Budapest, Hungary, H-1032
Debreceni Egyetem Klinikai Kozpont Recruiting
Debrecen, Hungary, 4032
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza Recruiting
Gyula, Hungary, 5700
Somogy Megyei Kaposi Mor Oktato Korhaz Active, not recruiting
Kaposvar, Hungary, 7400
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont Completed
Letavertes, Hungary, 4281
Mohacsi Korhaz Recruiting
Mohacs, Hungary, 7700
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz Completed
Nyiregyhaza, Hungary, 4400
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Active, not recruiting
Szekesfehervar, Hungary, 8000
Israel
Wolfson Medical Center Completed
Holon, Israel, 58100
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Kaplan Medical Center Recruiting
Rechovot, Israel, 76100
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Italy
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi Recruiting
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50134
Azienda Ospedaliero Universitaria San Martino Recruiting
Genova, Italy, 16132
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco Recruiting
Milano, Italy, 20157
A.O.U. Policlinico di Modena Recruiting
Modena, Italy, 41124
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) Recruiting
Monza, Italy, 20900
Azienda Ospedaliera Universitaria "Federico II" Recruiting
Napoli, Italy, 80131
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Azienda Ospedaliero Universitaria Pisana Recruiting
Pisa, Italy, 56124
Complesso Integrato Columbus Recruiting
Roma, Italy, 00168
Istituto Clinico Humanitas Recruiting
Rozzano (MI), Italy, 20089
IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo FG, Italy, 71013
Korea, Republic of
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of, 612-030
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 42415
Konyang University Hospital Completed
Daejeon, Korea, Republic of, 302-718
Hanyang Univerisy Guri Hospital Recruiting
Guri-si, Korea, Republic of, 471-701
CHA Bundang Medical Center CHA University Recruiting
Seongnam-si,, Korea, Republic of, 13496
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 02447
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Korea University Anam Hospital Completed
Seoul, Korea, Republic of, 136-705
Asan Medical Center Completed
Seoul, Korea, Republic of, 138-736
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 3181
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of, 3722
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 7985
The Catholic University of Korea, St.Vicent's Hospital Recruiting
Suwon, Korea, Republic of, 442-723
Yonsei University Wonju Severance Christian Hospital Recruiting
Wonju-Si, Korea, Republic of, 220701
Latvia
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia, LV1002
Moldova, Republic of
"Sfanta Treime" Clinical Municipal Hospital Recruiting
Chisinau, Moldova, Republic of, MD-2068
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery Completed
Chisinau, Moldova, Republic of, MD2005
"Sf. Arhanghel Mihail" Municipal Clinical Hospital Recruiting
Chisinau, Moldova, Republic of, MD2025
Republican Clinical Hospital Recruiting
Chisinau, Moldova, Republic of, MD2025
Netherlands
Vrije Universiteit Medisch Centrum (VUMC) Recruiting
Amsterdam, Netherlands, 1081 HV
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
Universitair Medisch Centrum Groningen (UMCG) Recruiting
Groningen, Netherlands, 9700 RB
Maastricht University Medical Center Completed
Maastrich, Netherlands, 6202 AZ
Zuyderland Medisch Centrum - Sittard-Geleen Recruiting
Sittard-Geleen, Netherlands, 6162 BG
ETZ Elisabeth Recruiting
Tilburg, Netherlands, 5022 GC
New Zealand
Christchurch Hospital NZ Completed
Christchurch, New Zealand, 8011
Dunedin Public Hospital Active, not recruiting
Dunedin, New Zealand, 9016
Poland
Clinsante S.C. Osrodek Badan Klinicznych Recruiting
Bydgoszcz, Poland, 85-794
Specjalistyczna Przychodnia Lekarska Medicus Recruiting
Chorzow, Poland, 41-500
GLOBE Clinical Research Sp. z o.o. LLC Recruiting
Klodzko, Poland, 57-300
PLEJADY Sp. z o.o. (LLC) Medical Centre Recruiting
Krakow, Poland, 30-363
Centrum Medyczne A-Z Clinic Completed
Kraków, Poland, 31-315
Healthcare Center Orkan Med Stec Michalska Spolka Jawna Recruiting
Ksawerow, Poland, 95-054
Santa Familia Centrum Badan, Profilaktyki i Leczenia Recruiting
Lodz, Poland, 90-302
KO-MED Centra Kliniczne Lublin II Recruiting
Lublin, Poland, 20-362
Trialmed Llc Recruiting
Piotrkow Trybunalski, Poland, 97-300
SOLUMED Centrum Medyczne Completed
Poznan, Poland, 60-529
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski Recruiting
Sopot, Poland, 81-756
KO-MED Centra Kliniczne Staszow Recruiting
Staszow, Poland, 28-200
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe Recruiting
Torun, Poland, 87-100
MDM Healthcare Centre Recruiting
Warsaw, Poland, 00-632
Nzoz Vivamed Completed
Warsaw, Poland, 03-580
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice Recruiting
Wierzchoslawice, Poland, 33-122
LexMedica Osrodek Badan Klinicznych Recruiting
Wroclaw, Poland, 53-114
Romania
Bacau County Emergency Hospital, Department of Gastroenterology Recruiting
Bacau, Romania, 600114
Hyperclinica MedLife Grivita Recruiting
Bucharest, Romania, 010719
Bucharest University Emergency Hospital, Department of Internal Medicine II Recruiting
Bucharest, Romania, 050098
TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy Completed
Cluj-Napoca, Romania, 400132
Sf. Apostol Andrei Constanta Emergency Clinical County Hospital Completed
Constanta, Romania, 900591
Craiova County Emergency Clinical Hospital Recruiting
Craiova, Romania, 200642
"Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology Recruiting
Timisoara, Romania, 300723
Russian Federation
Multidisciplinary Medical Clinic "Anthurium" Recruiting
Barnaul, Russian Federation, 656043
Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways Recruiting
Irkutsk, Russian Federation, 664005
SBEI HPE "Kazan State Medical University" of the MoH of the RF Recruiting
Kazan, Russian Federation, 420012
FSBIH "Central Clinical Hospital of Russian Academy of Sciences" Completed
Moscow, Russian Federation, 119333
SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko" Recruiting
Nizhniy Novgorod, Russian Federation, 603126
SBEIHPE Novosibirsk State Medical University Recruiting
Novosibirsk, Russian Federation, 630054
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS Recruiting
Novosibirsk, Russian Federation, 630117
BHI of Omsk region "Clinical Oncology Dispensary" Recruiting
Omsk, Russian Federation, 644013
SBEI HPE Rostov State Medical University of the MoH of the RF Recruiting
Rostov-on-Don, Russian Federation, 344022
SBIH City Clinical Hospital #31 Recruiting
Saint Petersburg, Russian Federation, 194291
Union Clinic Active, not recruiting
Saint-Peterburg, Russian Federation, 191119
FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia Recruiting
Saint-Petersburg, Russian Federation, 194044
SPb SBIH City Hospital # 26 Recruiting
Saint-Petersburg, Russian Federation, 196247
Pavlov First Saint Petersburg State Medical University Recruiting
Saint-Petersburg, Russian Federation, 197022
Private Educational Institution of Higher Education "Medical University "REAVIZ" Recruiting
Samara, Russian Federation, 443011
LLC Medical Company Hepatologist Recruiting
Samara, Russian Federation
FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine" Recruiting
St. Petersburg, Russian Federation, 194044
SPb SBIH Alexandrovskaya City Hospital Recruiting
St.Petersburg, Russian Federation, 193312
SBEI HPE "Stavropol State Medical Academy" MoH of RF Recruiting
Stavropol, Russian Federation, 355017
Regional Clinical Hospital Active, not recruiting
Vladimir, Russian Federation, 600023
Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine Recruiting
Belgrade, Serbia, 11 080
Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology Completed
Belgrade, Serbia, 11000
Clinical Hospital Center Zvezdara Clinic of Internal Diseases Recruiting
Belgrade, Serbia, 11000
Military Medical Academy, Clinic of Gastroenterology and Hepatology Recruiting
Belgrade, Serbia, 11000
Clinical Hospital Center Zemun Department of Gastroenterology Recruiting
Belgrade, Serbia, 11080
Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology Recruiting
Kragujevac, Serbia, 34000
Clinical Center Nis, Clinic of Gastroenterology and Hepatology Completed
Nis, Serbia, 18 000
General Hospital Djordje Jovanovic Zrenjanin Recruiting
Zrenjanin, Serbia, 23 000
Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Recruiting
Banska Bystrica, Slovakia, 97517
Alian s.r.o. Recruiting
Bardejov, Slovakia, 08501
PRO SANUS, a.s., Poliklinika ProCare Central Recruiting
Bratislava, Slovakia, 82107
IBDcentrum s.r.o. Completed
Bratislava, Slovakia, 83104
Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia Recruiting
Ilava, Slovakia, 01901
Gastroped s.r.o. Completed
Kosice, Slovakia, 040 01
Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o. Recruiting
Malacky, Slovakia, 90122
PIGEAS s.r.o. Recruiting
Martin, Slovakia, 3601
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s. Active, not recruiting
Michalovce, Slovakia, 7101
Gastromedic s.r.o. Recruiting
Nove Zamky, Slovakia, 94002
EndoCorp s.r.o. Recruiting
Trnava, Slovakia, 917 75
South Africa
Dr MJ Prins Practice Recruiting
Cape Town, South Africa, 7500
Tiervlei Trial Centre Completed
Cape Town, South Africa, 7550
Endocare Research Completed
Cape Town, South Africa, 7646
Dr JP Wright Practice Completed
Cape Town, South Africa, 7708
Dr YS Nanabhay Practice Completed
Johannesburg, South Africa, 2193
Emmed Research Recruiting
Pretoria, South Africa, 0084
Spain
University Hospital Germans Trias i Pujol Completed
Badalona, Spain, 08916
University Hospital of the Canary Islands (HUC) La Laguna Recruiting
La Laguna, Spain, 38320
Hospital Universitario de Gran Canaria Dr. Negrin Not yet recruiting
Las Palmas de Gran Canaria, Spain, 35012
University Hospital Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Ukraine
RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU Recruiting
Chernivtsi, Ukraine, 58002
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital Recruiting
Dnipropetrovsk, Ukraine, 49027
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases Recruiting
Dnipropetrovsk, Ukraine, 49074
Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU Completed
Ivano-Frankivsk, Ukraine, 76014
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU Recruiting
Ivano-Frankivsk, Ukraine, 76018
CI of PH Kharkiv CCH #2 Completed
Kharkiv, Ukraine, 61037
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine Recruiting
Kharkiv, Ukraine, 61039
Kyiv City Clinical Hospital #1 Recruiting
Kyiv, Ukraine, 02091
SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU Recruiting
Kyiv, Ukraine, 04053
CI of Kyiv RC Regional Clinical Hospital #2 Recruiting
Kyiv, Ukraine, 04073
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE Recruiting
Kyiv, Ukraine, 04201
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU Completed
Kyiv, Ukraine, 1030
Lviv Regional Clinical Hospital Recruiting
Lviv, Ukraine, 79010
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU Recruiting
Lviv, Ukraine, 79059
CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Recruiting
Sumy, Ukraine, 40021
Sumy Regional Clinical Hospital Recruiting
Sumy, Ukraine, 40022
CI of TRC Ternopil University Hospital Completed
Ternopil, Ukraine, 46002
A. Novak Transcarpathian Regional Clinical Hospital Completed
Uzhgorod, Ukraine, 88018
MCIC MC LLC Health Clinic Completed
Vinnytsia, Ukraine, 02029
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War Recruiting
Vinnytsia, Ukraine, 21005
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU Recruiting
Vinnytsia, Ukraine, 21018
Vinnytsia M.I. Pyrohov Regional Clinical Hospital Completed
Vinnytsia, Ukraine, 21018
Vinnytsia M.I. Pyrohov National Medical University Recruiting
Vinnytsia, Ukraine, 21029
City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya Recruiting
Zaporizhia, Ukraine, 69000
Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology Completed
Zaporizhia, Ukraine, 69065
CI City Hospital #1 Completed
Zaporizhia, Ukraine, 69104
CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU Recruiting
Zaporizhzhia, Ukraine, 69065
Zaporizhia Regional Clinical Hospital Recruiting
Zaporizhzhia, Ukraine, 69600
Central District Hospital under Zhytomyr District Council Recruiting
Zhytomyr, Ukraine, 12430
United Kingdom
University Hospital Coventry Completed
Coventry, United Kingdom, CV2 2DX
Royal Devon and Exeter Hospital (Wonford) Completed
Exeter, United Kingdom, EX2 5DW
Gloucestershire Royal Hospital Completed
Gloucester, United Kingdom, GL1 3NN
Whipps Cross University Hospital Recruiting
London, United Kingdom, E11 1NR
St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Royal Shrewsbury Hospital Recruiting
Shrewsbury, United Kingdom, SY38XQ
Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: AnnKatrin Petersen, M.D., MSc. Celgene

Additional Information:
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02435992     History of Changes
Other Study ID Numbers: RPC01-3101
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases