An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Crohn Disease Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03467958
• Other study ID #: RPC01-3204
• Secondary ID: U1111-1203-82032
• Status: Recruiting
• Phase: Phase 3
• Start date: August 24, 2018
• Est. completion date: March 24, 2031

Study information

• Verified date: May 2024
• Source: Celgene
• Contact: Recruiting sites have contact information. Please contact the si
• Phone: please email:
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: March 24, 2031
• Est. primary completion date: December 23, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

• Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies

• Experience relapse or who complete the Maintenance Study

• Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation

Exclusion Criteria:

• Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study

• Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated

• Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Ozanimod
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 500	Buenos Aires
Argentina	Local Institution - 501	Buenos Aires
Argentina	Local Institution - 568	Buenos Aires
Argentina	Local Institution - 571	Buenos Aires
Argentina	Local Institution - 494	Ciudad Autonoma de Buenos Aires
Argentina	Local Institution - 495	Cordoba
Argentina	Local Institution - 570	Cordoba
Argentina	Local Institution - 569	Mar del Plata
Argentina	Local Institution - 496	Rosario
Argentina	Universidad Nacional De Rosario - Hospital Provincial Del Centenario	Rosario
Argentina	Local Institution - 502	Rosario, Santa Fe
Argentina	Local Institution - 492	San Miguel de Tucuman
Australia	Local Institution - 308	Adelaide	South Australia
Australia	Lyell McEwin Hospital	Adelaide	South Australia
Australia	Local Institution - 325	Bankstown
Australia	Local Institution - 307	Bedford Park	South Australia
Australia	Local Institution - 330	Box Hill
Australia	Local Institution - 317	Clayton	Victoria
Australia	Local Institution - 310	Concord	New South Wales
Australia	Local Institution - 326	Elizabeth Vale	South Australia
Australia	Local Institution - 305	Fitzroy	Victoria
Australia	Local Institution - 329	Geelong	Victoria
Australia	Local Institution - 328	Herston	Queensland
Australia	Local Institution - 319	Kingswood	New South Wales
Australia	Local Institution - 309	Liverpool	New South Wales
Australia	Local Institution - 707	Maroochydore	Queensland
Australia	Local Institution - 313	Maroorchydore	Queensland
Australia	Local Institution - 327	Melbourne	Victoria
Australia	Local Institution - 709	Melbourne	Victoria
Australia	Local Institution - 316	Murdoch	Western Australia
Australia	Local Institution - 318	New Lambton Heights	New South Wales
Australia	Local Institution - 321	North Mackay	Queensland
Australia	Local Institution - 312	South Brisbane	Queensland
Australia	Local Institution - 315	Subiaco	Western Australia
Australia	Local Institution - 324	Sydney, NSW
Australia	Local Institution - 323	Wollongong	New South Wales
Australia	Local Institution - 320	Woodville South	South Australia
Australia	Local Institution - 311	Woolloongabba	Queensland
Austria	Local Institution - 726	Innsbruck
Austria	Local Institution - 727	St Polten
Austria	Local Institution - 336	Vienna
Austria	Local Institution - 725	Vienna
Belarus	Local Institution - 745	Grodno
Belarus	Local Institution - 737	Vitebsk
Belgium	Local Institution - 943	Brasschaat	Antwerpen
Belgium	Local Institution - 940	Brussels
Belgium	Local Institution - 939	Edegem
Belgium	Local Institution - 937	Ghent
Belgium	Local Institution - 942	Leuven
Belgium	Local Institution - 936	Liege
Belgium	Local Institution - 938	Seraing
Belgium	Local Institution - 941	Tournai
Bosnia and Herzegovina	Local Institution - 743	Banja Luka
Bosnia and Herzegovina	Local Institution - 741	Mostar
Bosnia and Herzegovina	Local Institution - 738	Sarajevo
Bosnia and Herzegovina	Local Institution - 742	Sarajevo
Bulgaria	Local Institution - 456	Blagoevgrad
Bulgaria	Local Institution - 746	Plovdiv
Bulgaria	Local Institution - 753	Ruse
Bulgaria	Local Institution - 554	Sofia
Bulgaria	Local Institution - 627	Sofia
Bulgaria	Local Institution - 747	Sofia
Bulgaria	Local Institution - 749	Sofia
Bulgaria	Local Institution - 750	Sofia
Bulgaria	Local Institution - 755	Sofia
Bulgaria	Local Institution - 756	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD	Sofia
Bulgaria	Local Institution - 553	Stara Zagora
Bulgaria	Local Institution - 754	Varna
Canada	Local Institution - 256	Brandon	Manitoba
Canada	Local Institution - 268	Bridgewater	Nova Scotia
Canada	Local Institution - 273	Calgary	Alberta
Canada	GIRI Gastroenterology and Internal Medicine Research Institute	Edmonton	Alberta
Canada	Local Institution - 269	Edmonton	Alberta
Canada	Local Institution - 263	Kelowna	British Columbia
Canada	LHSC Victoria Hospital	London	Ontario
Canada	Local Institution - 252	London	Ontario
Canada	Local Institution - 254	Montreal	Quebec
Canada	Local Institution - 262	New Westminister	British Columbia
Canada	Local Institution - 270	Ottawa	Quebec
Canada	Local Institution - 266	Sudbury	Ontario
Canada	Local Institution - 257	Toronto	Ontario
Canada	Local Institution - 264	Toronto	Ontario
Canada	Local Institution - 255	Vancouver	British Columbia
Canada	Local Institution - 267	Vancouver	British Columbia
Canada	Local Institution - 271	Vaughan	Ontario
Canada	Local Institution - 261	Winnipeg	Manitoba
Chile	Hospital Regional de Concepción Dr. Guillermo Grant Benavente	Concepción
Chile	Local Institution - 393	La Serena
Chile	Centro de Estudios Clinicos e Investigaciones Médicas (CECIM)	Santiago
Chile	De los Andes Clinic	Santiago
Chile	Local Institution - 387	Santiago
Chile	Medical Services Society	Santiago
China	Local Institution - 382	Beijing
China	Local Institution - 467	Beijing
China	Local Institution - 471	Beijing
China	Local Institution - 482	Beijing
China	Local Institution - 489	Beijing
China	Local Institution - 379	Bengbu
China	Local Institution - 376	Changchun
China	Local Institution - 485	Changchun
China	Local Institution - 378	Changsha
China	Xiangya Hospital Central South University	Changsha
China	Local Institution - 414	Changzhou
China	Local Institution - 423	Changzhou City	Jiangsu
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Local Institution - 422	Fuzhou
China	Local Institution - 478	Guangzhou
China	Local Institution - 472	Guangzhou Shi
China	Local Institution - 486	Guangzhou Shi
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou, Zhejiang
China	Local Institution - 491	Hefei
China	Local Institution - 374	Kunming
China	Local Institution - 383	Luzhou
China	Local Institution - 488	Nanchang
China	Local Institution - 487	Nanjing
China	Zhongda Hospital Southeast University	Nanjing
China	Local Institution - 418	Nanjing City
China	Local Institution - 377	Shanghai
China	Local Institution - 380	Shanghai
China	Local Institution - 416	Shanghai
China	Local Institution - 417	Shanghai
China	Local Institution - 468	Shanghai
China	Local Institution - 473	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	Local Institution - 424	Suzhou	Jiangsu
China	China Medical University Hospital	Taichung City
China	Local Institution - 373	Tianjin
China	Local Institution - 425	Wenzhou CITY
China	Local Institution - 474	Wuhan
China	Local Institution - 475	Wuhan
China	Wuhan University - Renmin Hospital (Hubei General Hospital)	Wuhan Shi
China	Local Institution - 381	Wuxi
China	Local Institution - 415	Xi'an
China	Local Institution - 420	Xi'an
China	Local Institution - 481	Zhangzhou
China	The Second Affiliated Hospital Of Zhengzhou University	Zhengzhou
Colombia	Cardiomet CEQUIN Foundation	Armenia
Colombia	Local Institution - 398	Barranquilla
Colombia	Local Institution - 395	Bogota
Colombia	Local Institution - 396	Cali
Colombia	Local Institution - 394	Medellin
Croatia	Local Institution - 763	Osijek
Croatia	Local Institution - 764	Rijeka
Croatia	Local Institution - 765	Split
Croatia	Local Institution - 761	Zagreb
Croatia	Local Institution - 762	Zagreb
Croatia	Local Institution - 766	Zagreb
Czechia	Local Institution - 772	Brno
Czechia	Military Hospital Brno	Brno
Czechia	Local Institution - 773	Hradec Králové
Czechia	Local Institution - 775	Most
Czechia	Local Institution - 771	Olomouc
Czechia	Local Institution - 774	Pardubice
Czechia	Local Institution - 769	Plzen
Czechia	Local Institution - 368	Prague
Czechia	Local Institution - 573	Prague
Czechia	Local Institution - 768	Prague 5
Czechia	Local Institution - 770	Prague 9
Czechia	Local Institution - 776	Praha 4
Denmark	Local Institution - 611	Copenhagen
Denmark	Local Institution - 610	Holbaek
Denmark	Local Institution - 609	Nykobing F
Finland	Local Institution - 613	Helsinki
Finland	Local Institution - 614	Turku
France	Local Institution - 638	Amiens cedex 1
France	Local Institution - 639	Béziers
France	Local Institution - 635	Blois Cedex
France	Local Institution - 634	Caen
France	Local Institution - 644	Colombes
France	Local Institution - 711	Creteil Cedex
France	Local Institution - 616	Dijon Cedex
France	Local Institution - 615	Grenoble Cedex 9
France	Local Institution - 633	Lillie Cedex
France	Local Institution - 646	Marseille cedex 20
France	Local Institution - 507	Montpellier
France	Local Institution - 632	Nantes
France	Local Institution - 647	Neuilly-sur-Seine	Cedex
France	Local Institution - 630	Pierre-Benite
France	Local Institution - 641	Rennes
France	Local Institution - 612	Rouen Cedex
France	Local Institution - 631	Saint Priest en Jarez
France	Local Institution - 643	Toulouse Cedex 09
Georgia	Local Institution - 786	Batumi
Georgia	Local Institution - 779	Kutaisi
Georgia	JSC Vian	Tbilisi
Georgia	Local Institution - 247	Tbilisi
Georgia	Local Institution - 248	Tbilisi
Georgia	Local Institution - 249	Tbilisi
Georgia	Local Institution - 250	Tbilisi
Georgia	Local Institution - 335	Tbilisi
Georgia	Local Institution - 740	Tbilisi
Georgia	Local Institution - 778	Tbilisi
Georgia	Local Institution - 782	Tbilisi
Georgia	Local Institution - 783	Tbilisi
Georgia	Local Institution - 784	Tbilisi
Georgia	Local Institution - 785	Tbilisi
Georgia	Local Institution - 793	Tbilisi
Georgia	Local Institution - 780	Telavi
Germany	Local Institution - 626	Berlin
Germany	Local Institution - 628	Berlin
Germany	Local Institution - 629	Berlin
Germany	Local Institution - 648	Berlin
Germany	Local Institution - 650	Berlin
Germany	Local Institution - 653	Berlin
Germany	Local Institution - 665	Berlin
Germany	Local Institution - 664	Brandenburg an der Havel
Germany	Local Institution - 732	Dachau
Germany	Local Institution - 654	Frankfurt
Germany	Local Institution - 662	Frankfurt
Germany	Local Institution - 574	Frankfurt am Main
Germany	Local Institution - 657	Frankfurt am Main
Germany	Local Institution - 656	Halle
Germany	Local Institution - 658	Halle
Germany	Local Institution - 652	Hamburg
Germany	Local Institution - 659	Hamburg
Germany	Local Institution - 591	Hannover
Germany	Local Institution - 649	Keil
Germany	Local Institution - 337	Leipzig
Germany	Local Institution - 651	Leipzig
Germany	Local Institution - 730	Ludwigshafen am Rhein
Germany	Practice for Gastroenterology and Internal Medicine	Ludwigshafen am Rhein
Germany	Local Institution - 660	Mainz
Germany	Local Institution - 667	Muenster
Germany	Local Institution - 620	Neuruppin
Germany	Local Institution - 584	Nuertingen
Germany	Local Institution - 661	Stuttgart
Germany	Local Institution - 666	Tuebingen
Germany	Local Institution - 663	Ulm
Greece	Local Institution - 588	Athens
Greece	Local Institution - 790	Athens
Greece	Local Institution - 791	Athens
Greece	Local Institution - 792	Athens
Greece	Local Institution - 592	Athens, Attiki
Greece	Local Institution - 787	Heraklion
Greece	Local Institution - 788	Thessaloniki
Greece	Local Institution - 789	Thessaloniki
Hong Kong	Local Institution - 404	Hong Kong
Hong Kong	Local Institution - 405	Kowloon
Hong Kong	Local Institution - 406	Sha Tin
Hungary	Local Institution - 798	Bekescsaba
Hungary	Local Institution - 556	Budapest
Hungary	Local Institution - 803	Budapest
Hungary	Semmelweis Egyetem - Altalanos Orvostudomanyi Kar	Budapest
Hungary	Local Institution - 801	Gyor
Hungary	Local Institution - 555	Gyula
Hungary	Local Institution - 797	Miskolc
Hungary	Local Institution - 800	Nagykanizsa
Hungary	Local Institution - 799	Szekesfehervar
Hungary	Local Institution - 816	Szekszárd
Hungary	Local Institution - 805	Szentes
India	Local Institution - 333	Belgaum	Karnatka
India	Local Institution - 408	Coimbatore	Tamil Nadu
India	G.B. Pant Hospital	Delhi
India	Local Institution - 332	Gurgaon	Haryana
India	Local Institution - 331	Hyderabad	Telangana
India	Local Institution - 444	Hyderabad	Andhra Pradesh
India	Local Institution - 443	Jaipur	Rajasthan
India	S R Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan
India	Local Institution - 409	Kochi	Kerala
India	Local Institution - 445	Kochi	Kerala
India	Local Institution - 446	Ludhiana	Punjab
India	Local Institution - 411	New Delhi
India	Surat Institute of Digestive Sciences	Surat	Gujarat
Ireland	Local Institution - 975	Dublin 4	Dublin
Ireland	Beaumont Hospital	Dublin 9
Israel	Local Institution - 343	Afula
Israel	Local Institution - 345	Bat Yam
Israel	Local Institution - 346	Beer Jacob
Israel	Local Institution - 350	Haifa
Israel	Local Institution - 339	Jerusalem
Israel	Local Institution - 347	Jerusalem
Israel	Local Institution - 349	Kfar-Saba
Israel	Local Institution - 344	Nahariya
Israel	Local Institution - 341	Petah Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Local Institution - 338	Rechovot
Israel	Local Institution - 340	Tel-Aviv
Italy	Local Institution - 677	Bologna
Italy	Local Institution - 684	Brescia
Italy	Local Institution - 688	Brescia
Italy	Local Institution - 689	Castellana Grotte
Italy	Local Institution - 679	Catanzaro
Italy	Local Institution - 687	Chieti
Italy	Local Institution - 674	Messina
Italy	Local Institution - 672	Milan
Italy	I.R.C.C.S. Ospedale San Raffaele	Milano
Italy	Local Institution - 686	Milano
Italy	Local Institution - 678	Monza
Italy	Local Institution - 685	Padova
Italy	Local Institution - 682	Palermo
Italy	Local Institution - 673	Pavia
Italy	Local Institution - 675	Roma
Italy	Local Institution - 681	Roma
Italy	Local Institution - 671	Rome
Italy	Local Institution - 680	Udine
Italy	Local Institution - 670	Varese
Italy	Local Institution - 676	Verona
Korea, Republic of	Local Institution - 437	Ansan
Korea, Republic of	Local Institution - 431	Busan
Korea, Republic of	Local Institution - 434	Busan
Korea, Republic of	Local Institution - 441	Busan
Korea, Republic of	Local Institution - 432	Daegu
Korea, Republic of	Local Institution - 435	Guri-si
Korea, Republic of	Local Institution - 436	Seongnam-si
Korea, Republic of	Local Institution - 427	Seoul
Korea, Republic of	Local Institution - 430	Seoul
Korea, Republic of	Local Institution - 433	Seoul
Korea, Republic of	Local Institution - 438	Seoul
Korea, Republic of	Local Institution - 439	Seoul
Korea, Republic of	Local Institution - 440	Seoul
Korea, Republic of	Local Institution - 442	Seoul
Korea, Republic of	Local Institution - 429	Suwon
Latvia	Local Institution - 600	Riga
Latvia	Local Institution - 601	Riga
Latvia	P. Stradins Clinical University Hospital	Riga
Lithuania	Local Institution - 605	Kaunas
Lithuania	Local Institution - 603	Klaipeda
Lithuania	Local Institution - 604	Vilnius
Lithuania	Local Institution - 606	Vilnius
Lithuania	Local Institution - 607	Vilnius
Mexico	Local Institution - 528	Chihuahua
Mexico	Centro de Investigación y Gastroenterología	Ciudad de México	Distrito Federal
Mexico	Local Institution - 450	Ciudad de México	Distrito Federal
Mexico	Local Institution - 527	Mexico
Mexico	Local Institution - 448	Mexico City
Mexico	Local Institution - 447	Monterrey	Nuevo León
Mexico	Local Institution - 449	Monterrey	Nuevo León
Mexico	Local Institution - 525	Monterrey	Nuevo León
Mexico	Local Institution - 532	Monterrey	Nuevo León
Mexico	Local Institution - 529	Santiago de Queretaro	Querétaro
Mexico	Local Institution - 530	Tlalpan
Mexico	Local Institution - 526	Zapapan	Jalisco
Moldova, Republic of	"Sfanta Treime" Clinical Municipal Hospital	Chisinau
Moldova, Republic of	Local Institution - 810	Chisinau
Moldova, Republic of	Local Institution - 812	Chisinau
Moldova, Republic of	Local Institution - 813	Chisinau
Moldova, Republic of	Republican Clinical Hospital	Chisinau
Netherlands	Local Institution - 952	Amsterdam
Netherlands	Local Institution - 955	Amsterdam
Netherlands	Local Institution - 956	Groningen
Netherlands	Local Institution - 949	Nijmegen
Netherlands	Local Institution - 951	Sittard-Geleen
Netherlands	Local Institution - 954	Tilburg
Poland	Local Institution - 820	Bialystok
Poland	Local Institution - 818	Bochnia
Poland	Local Institution - 580	Czestochowa
Poland	Local Institution - 988	Elblag
Poland	Local Institution - 579	Gdansk
Poland	Local Institution - 978	Gdansk
Poland	Local Institution - 577	Gdynia
Poland	Private Medical Practice Miroslaw Fic	Jelenia Gora
Poland	Local Institution - 757	Jozefow
Poland	Local Institution - 238	Katowice
Poland	Local Institution - 819	Katowice
Poland	Local Institution - 828	Katowice
Poland	Synexus Polska Sp. z o.o. Branch in Katowice	Katowice
Poland	Local Institution - 817	Klodzko
Poland	Local Institution - 815	Krakow
Poland	Local Institution - 823	Krakow
Poland	Local Institution - 826	Krakow
Poland	Local Institution - 834	Ksawerow
Poland	Local Institution - 581	Lodz
Poland	Local Institution - 829	Lodz
Poland	Local Institution - 888	Lodz
Poland	Local Institution - 981	Lodz
Poland	Local Institution - 760	Lublin
Poland	Local Institution - 976	Nowy Targ
Poland	Provincial Specialist Hospital in Olsztyn	Olsztyn
Poland	Local Institution - 402	Opole
Poland	Local Institution - 400	Oswiecim
Poland	Local Institution - 401	Poznan
Poland	Local Institution - 758	Poznan
Poland	Synexus Polska Sp. z o.o. Branch in Poznan	Poznan
Poland	Local Institution - 963	Rzeszow
Poland	Dariusz Kleczkowski Specialist Medical Practice	Sopot
Poland	Local Institution - 239	Sopot
Poland	Local Institution - 235	Szczecin
Poland	TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC	Szczecin
Poland	Local Institution - 822	Torun
Poland	Local Institution - 824	Tychy
Poland	Local Institution - 827	Ul. Piotrkowska 177
Poland	Local Institution - 236	Warsaw
Poland	Local Institution - 410	Warsaw
Poland	Local Institution - 807	Warsaw
Poland	Local Institution - 833	Warsaw
Poland	WIP Warsaw IBD Point	Warsaw
Poland	Local Institution - 576	Warszawa
Poland	Local Institution - 825	Warszawa
Poland	Local Institution - 989	Warszawa
Poland	Local Institution - 893	Wierzchoslawice
Poland	Local Institution - 582	Wroclaw
Poland	Local Institution - 831	Wroclaw
Poland	Local Institution - 832	Wroclaw
Poland	Local Institution - 982	Wroclaw
Poland	Local Institution - 983	Wroclaw
Poland	Local Institution - 984	Wroclaw
Poland	Local Institution - 987	Wroclaw
Poland	Local Institution - 403	Zamosc	Lubelskie
Poland	Local Institution - 597	Zamosc	Lubelskie
Portugal	Local Institution - 959	Coimbra
Portugal	Local Institution - 958	Guimaraes
Portugal	Local Institution - 961	Loures
Portugal	Local Institution - 957	Viana do Castelo
Romania	Local Institution - 795	Bucharest
Romania	Local Institution - 808	Bucharest
Romania	Local Institution - 836	Bucharest
Romania	Local Institution - 837	Bucharest
Romania	Local Institution - 839	Bucharest
Romania	Local Institution - 842	Bucharest
Romania	Monza Oncology Hospital SRL, Department of Gastroenterology	Bucharest
Romania	Local Institution - 843	Craiova
Romania	Local Institution - 838	Napoca
Romania	Local Institution - 840	Targu Mures
Russian Federation	Local Institution - 871	Barnaul
Russian Federation	Local Institution - 966	Barnaul
Russian Federation	Local Institution - 589	Bataisk
Russian Federation	Local Institution - 621	Chelyabinsk
Russian Federation	Local Institution - 991	Chelyabinsk
Russian Federation	Local Institution - 598	Chita
Russian Federation	Local Institution - 583	Ekaterinburg
Russian Federation	Local Institution - 872	Ekaterinburg
Russian Federation	Local Institution - 848	Irkutsk
Russian Federation	Local Institution - 998	Kaliningrad
Russian Federation	Local Institution - 882	Kaluga
Russian Federation	Local Institution - 892	Kazan
Russian Federation	Local Institution - 849	Kemerovo
Russian Federation	Local Institution - 599	Khanty-mansiysk
Russian Federation	Local Institution - 927	Krasnoyarsk
Russian Federation	Local Institution - 566	Moscow
Russian Federation	Local Institution - 851	Moscow
Russian Federation	Local Institution - 869	Moscow
Russian Federation	Local Institution - 870	Moscow
Russian Federation	Local Institution - 873	Moscow
Russian Federation	Local Institution - 995	Moscow
Russian Federation	Local Institution - 990	Nizhny Novgorod
Russian Federation	Local Institution - 594	Novosibirsk
Russian Federation	Local Institution - 853	Novosibirsk
Russian Federation	Local Institution - 876	Novosibirsk
Russian Federation	Local Institution - 996	Omsk
Russian Federation	Local Institution - 875	Orenburg
Russian Federation	Local Institution - 867	Penza
Russian Federation	Local Institution - 858	Petrozavodsk
Russian Federation	Local Institution - 859	Pushkin
Russian Federation	Local Institution - 846	Pyatigorsk
Russian Federation	Local Institution - 960	Pyatigorsk
Russian Federation	Local Institution - 883	Rostov-on-Don
Russian Federation	Local Institution - 847	Saint Petersburg
Russian Federation	Local Institution - 874	Saint Petersburg
Russian Federation	Local Institution - 868	Saint-Petersburg
Russian Federation	Local Institution - 844	Samara
Russian Federation	Local Institution - 865	Samara
Russian Federation	Local Institution - 992	Saratov
Russian Federation	Local Institution - 866	Sochi
Russian Federation	Local Institution - 862	St Petersburg
Russian Federation	Local Institution - 878	St Petersburg
Russian Federation	Local Institution - 845	St. Petersburg
Russian Federation	Local Institution - 856	St. Petersburg
Russian Federation	Local Institution - 857	St. Petersburg
Russian Federation	Local Institution - 863	St. Petersburg
Russian Federation	Local Institution - 879	St. Petersburg
Russian Federation	Local Institution - 993	St. Petersburg
Russian Federation	Local Institution - 948	Surgut
Russian Federation	Local Institution - 877	Tomsk
Russian Federation	Local Institution - 806	Tula
Russian Federation	Local Institution - 861	Ufa
Russian Federation	Local Institution - 881	Ufa
Russian Federation	Local Institution - 642	Ulyanovsk
Russian Federation	Local Institution - 855	Veliky Novgorod
Russian Federation	Local Institution - 935	Vladimir
Russian Federation	Local Institution - 986	Vladivostok
Russian Federation	Local Institution - 999	Vladivostok
Russian Federation	Local Institution - 880	Volgograd
Saudi Arabia	Local Institution - 534	Dammam
Saudi Arabia	King Abdul Aziz University Hospital	Jeddah
Saudi Arabia	Local Institution - 535	Riyadh
Saudi Arabia	Local Institution - 536	Riyadh
Senegal	Local Institution - 546	Cape Town
Serbia	Clinical Hospital Center - Dr. Dragisa Misovic-Dedinje	Belgrade
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Local Institution - 596	Belgrade
Serbia	Local Institution - 887	Belgrade
Serbia	Local Institution - 890	Belgrade
Serbia	Military Medical Academy, Clinic of Gastroenterology and Hepatology	Belgrade
Serbia	Zvezdara University Medical Center	Belgrade
Serbia	Local Institution - 891	Kragujevac
Serbia	Local Institution - 884	Novi Sad
Serbia	Local Institution - 885	Pancevo
Serbia	Local Institution - 585	Vrsac
Serbia	Local Institution - 889	Zrenjanin
Slovakia	Local Institution - 894	Bratislava
Slovakia	Local Institution - 900	Bratislava
Slovakia	Local Institution - 895	Brezno
Slovakia	Local Institution - 899	Nitra
Slovakia	Local Institution - 897	Nove Zamky
Slovakia	GASTRO I., s.r.o.	Presov
Slovakia	Local Institution - 896	Rimavska Sobota
Slovenia	Local Institution - 904	Celje
South Africa	Local Institution - 550	Cape town
South Africa	Local Institution - 543	Gauteng
South Africa	Local Institution - 545	Kempton Park
South Africa	Local Institution - 551	Molotlegi Street
South Africa	Local Institution - 542	Pretoria
South Africa	Local Institution - 544	Pretoria
South Africa	Local Institution - 549	Pretoria
South Africa	Local Institution - 548	Somerset West
South Africa	Local Institution - 547	Val De Grace
Spain	Local Institution - 703	Alicante
Spain	Local Institution - 690	Badalona
Spain	Local Institution - 694	Barcelona
Spain	Local Institution - 702	Cordoba
Spain	Local Institution - 699	Girona
Spain	Local Institution - 698	La Laguna
Spain	Local Institution - 701	Las Palmas de Gran Canaria
Spain	Local Institution - 691	Madrid
Spain	Local Institution - 692	Madrid
Spain	Local Institution - 695	Madrid
Spain	Local Institution - 693	Majadahonda, Madrid
Spain	Local Institution - 706	Santander
Spain	Local Institution - 696	Sevilla
Spain	Local Institution - 705	Sevilla
Spain	Local Institution - 697	Valencia
Spain	Local Institution - 700	Viladecans
Sweden	Local Institution - 625	Stockholm
Switzerland	Local Institution - 967	Bern
Switzerland	Local Institution - 968	St.Gallen
Switzerland	Local Institution - 969	Zurich
Taiwan	Local Institution - 460	Kaohsiung
Taiwan	Local Institution - 463	Kaohsiung, San Ming Dist.
Taiwan	Local Institution - 363	Kozlu
Taiwan	Local Institution - 461	Niao-Sung Hsiang Kaohsiung County
Taiwan	Local Institution - 459	Tainan, Taiana
Taiwan	Chang Gung Memorial Hospital- Linkou	Taoyuan City
Taiwan	National Taiwan University Hospital	Tapei
Taiwan	Local Institution - 464	Tapei, Beitou Dist.
Turkey	Local Institution - 356	Ankara
Turkey	Local Institution - 357	Ankara
Turkey	Local Institution - 360	Bursa
Turkey	Local Institution - 365	Elazig
Turkey	Bezmialem Foundation University Medical Faculty	Istanbul
Turkey	Local Institution - 355	Istanbul
Turkey	Local Institution - 358	Istanbul
Turkey	Local Institution - 361	Istanbul
Turkey	Kocaeli University Medical Faculty	Izmit/Kocaeli
Turkey	Local Institution - 353	Kadiköy/Istanbul
Turkey	Local Institution - 367	Mersin
Turkey	Local Institution - 359	Trabzon
Ukraine	Chernivtsi Regional Clinical Hospital	Chernivtsi
Ukraine	Local Institution - 922	Chernivtsi
Ukraine	Local Institution - 950	Dnipropetrovsk
Ukraine	Ivano-Frankivsk Regional Clinical Hospital	Ivano-Frankivsk
Ukraine	Local Institution - 229	Ivano-Frankivsk
Ukraine	Local Institution - 912	Ivano-Frankivsk
Ukraine	Local Institution - 565	Kharkiv
Ukraine	Local Institution - 919	Kharkiv
Ukraine	Local Institution - 965	Kharkiv
Ukraine	Local Institution - 920	Khmelnytskyi
Ukraine	Local Institution - 933	Kropyvnytskyi
Ukraine	Center of Family Medicine Plus Limited Liability Company	Kyiv
Ukraine	Kyiv Regional Clinical Hospital	Kyiv
Ukraine	Limited Liability Company Edelweiss Medics	Kyiv
Ukraine	Local Institution - 244	Kyiv
Ukraine	Local Institution - 563	Kyiv
Ukraine	Local Institution - 564	Kyiv
Ukraine	Local Institution - 901	Kyiv
Ukraine	Local Institution - 918	Kyiv
Ukraine	Local Institution - 923	Kyiv
Ukraine	Local Institution - 977	Kyiv
Ukraine	Medical Center Consilium Medical	Kyiv
Ukraine	Ok Clinic Medical Center within International Institute of Clinical Trials, LLC	Kyiv
Ukraine	Local Institution - 590	Lutsk
Ukraine	Volyn Regional Clinical Hospital	Lutsk
Ukraine	Local Institution - 234	Lviv
Ukraine	Local Institution - 910	Lviv
Ukraine	Local Institution - 974	Lviv
Ukraine	Local Institution - 902	Odesa
Ukraine	Odesa Regional Clinical Hospital	Odesa
Ukraine	Local Institution - 905	Poltava
Ukraine	Local Institution - 934	Ternopil
Ukraine	Local Institution - 224	Vinnytsia
Ukraine	Local Institution - 909	Vinnytsia
Ukraine	Local Institution - 971	Vinnytsia
Ukraine	Vinnytsia M.I. Pyrohov Regional Clinical Hospital	Vinnytsia
Ukraine	Local Institution - 932	Vinnytsya
Ukraine	Local Institution - 587	Zaporizhia
Ukraine	Zaporizhzhya Regional	Zaporizhzhya
United Kingdom	Local Institution - 557	Birmingham
United Kingdom	Local Institution - 714	Bristol
United Kingdom	Local Institution - 560	Cardiff
United Kingdom	Local Institution - 558	Chorley
United Kingdom	Local Institution - 559	Corbridge Road
United Kingdom	Local Institution - 712	Dundonald
United Kingdom	Local Institution - 713	Glasgow
United Kingdom	Local Institution - 716	Lancashire Blackpool
United Kingdom	Local Institution - 715	London
United Kingdom	Local Institution - 722	London
United Kingdom	Local Institution - 729	London	LND
United Kingdom	Local Institution - 561	North Manchester Science Park
United Kingdom	Local Institution - 721	Oxford
United Kingdom	Local Institution - 593	Shrewsbury
United Kingdom	Local Institution - 723	Southampton	Hampshire
United Kingdom	Local Institution - 718	Torquay
United States	Local Institution - 017	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates, Llc	Atlanta	Georgia
United States	Children's Center for Digestive Healthcare	Atlanta	Georgia
United States	Consultative Gastroenterology	Atlanta	Georgia
United States	Emory Clinic	Atlanta	Georgia
United States	Local Institution - 220	Atlanta	Georgia
United States	The Emory Clinic	Atlanta	Georgia
United States	Local Institution - 158	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Gastroenterology Associates, Llc	Baton Rouge	Louisiana
United States	Great Lakes Medical Research, LLC	Beachwood	Ohio
United States	Connecticut Clinical Research Foundation	Bristol	Connecticut
United States	Connecticut Clinical Research Institute	Bristol	Connecticut
United States	Advantage Clinical Trials	Bronx	New York
United States	Local Institution - 144	Brooklyn	New York
United States	Om Research, LLC	Camarillo	California
United States	Local Institution - 191	Caro	Michigan
United States	Local Institution - 129	Catonsville	Maryland
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Local Institution - 055	Charlotte	North Carolina
United States	Local Institution - 152	Charlotte	North Carolina
United States	Local Institution - 156	Charlotte	North Carolina
United States	Brigham and Women's Hospital - Crohn's and Colitis Center	Chestnut Hill	Massachusetts
United States	Local Institution - 022	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center - University Cardiovascular Surgeons	Chicago	Illinois
United States	Sharp Chula Vista Medical Center	Chula Vista	California
United States	Local Institution - 291	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Gastro Florida	Clearwater	Florida
United States	South Lake Pain Institute	Clermont	Florida
United States	Local Institution - 018	Cleveland	Ohio
United States	Iowa Digestive Disease Center	Clive	Iowa
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Local Institution - 074	Columbus	Georgia
United States	American Research Institute Inc	Cutler Bay	Florida
United States	Local Institution - 170	Dayton	Ohio
United States	Local Institution - 143	Decatur	Georgia
United States	Local Institution - 112	Doral	Florida
United States	Riverside Clinical Research	Edgewater	Florida
United States	Local Institution - 215	Englewood	New Jersey
United States	Local Institution - 092	Evansville	Indiana
United States	Local Institution - 034	Fort Sam Houston	Texas
United States	Local Institution - 189	Gainesville	Virginia
United States	University of Florida Health Endocrinology - Medical Specialties - Medical Plaza	Gainesville	Florida
United States	Valley View Internal Medicine	Garden Grove	California
United States	Woodholme Gastroenterology Associates	Glen Burnie	Maryland
United States	Aurora Health Care Aurora Research	Grafton	Wisconsin
United States	Northwell Health	Great Neck	New York
United States	Carolina Research Center	Greenville	North Carolina
United States	Local Institution - 054	Hartsdale	New York
United States	Local Institution - 197	Hershey	Pennsylvania
United States	Floridian Clinical Research LLC	Hialeah	Florida
United States	Harmony Medical Research Institute	Hialeah	Florida
United States	Local Institution - 203	Hialeah	Florida
United States	Local Institution - 049	Hilliard	Ohio
United States	Local Institution - 179	Hollywood	Florida
United States	Vista Health Research	Homestead	Florida
United States	CroNOLA LLC	Houma	Louisiana
United States	Biopharma Informatic Inc. Research Center	Houston	Texas
United States	Centex Studies, Inc.	Houston	Texas
United States	GI Specialists of Houston	Houston	Texas
United States	Gulf Coast Research Group LLC	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Local Institution - 088	Houston	Texas
United States	Local Institution - 196	Houston	Texas
United States	Southwest Clinical Trials	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	Grand Teton Research Group, PLLC	Idaho Falls	Idaho
United States	Local Institution - 033	Indianapolis	Indiana
United States	Local Institution - 274	Jackson	Mississippi
United States	Western Michigan University Homer Stryker M.D. School of Medicine	Kalamazoo	Michigan
United States	Local Institution - 198	Kansas City	Missouri
United States	SIH Research	Kissimmee	Florida
United States	Local Institution - 089	La Crosse	Wisconsin
United States	Ucsd Medical Center	La Jolla	California
United States	San Diego Clinical Trials	La Mesa	California
United States	Centex Studies, Inc.	Lake Charles	Louisiana
United States	Clinical Trials of SW Louisiana LLC	Lake Charles	Louisiana
United States	Topography Health	Lakewood	Colorado
United States	OM Research	Lancaster	California
United States	Local Institution - 016	Largo	Florida
United States	Internal Medicine Specialists	Las Vegas	Nevada
United States	Local Institution - 040	Lebanon	New Hampshire
United States	University Of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Local Institution - 067	Lighthouse Point	Florida
United States	Local Institution - 061	Los Angeles	California
United States	Local Institution - 110	Los Angeles	California
United States	Matrix Clinical Research Inc	Los Angeles	California
United States	Southern California Research Institute Medical Group, Inc.	Los Angeles	California
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Local Institution - 028	Macon	Georgia
United States	Center For Advanced Gastroenterology	Maitland	Florida
United States	Gastroenterology Associates P.C.	Manassas	Virginia
United States	Tandem Clinical Research, LLC	Marrero	Louisiana
United States	VA Northern California Health Care System	Mather	California
United States	Great Lakes Gastroenterology	Mentor	Ohio
United States	LCC Medical Research Institute, LLC	Miami	Florida
United States	Life Medical Center & Research, Inc.	Miami	Florida
United States	LMG Research	Miami	Florida
United States	Local Institution - 199	Miami	Florida
United States	Research Associates of South Florida LLC	Miami	Florida
United States	Vista Health Research	Miami	Florida
United States	Local Institution - 044	Miami Springs	Florida
United States	Paramount Medical Research & Consulting, Llc	Middleburg Heights	Ohio
United States	Local Institution - 095	Minneapolis	Minnesota
United States	Facey Medical Foundation (Parent)	Mission Hills	California
United States	ABS Health, LLC	Mission Viejo	California
United States	Advanced Research for Health Improvement	Naples	Florida
United States	Local Institution - 121	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Local Institution - 091	New Haven	Connecticut
United States	Nola Research Works	New Orleans	Louisiana
United States	Local Institution - 192	New Port Richey	Florida
United States	NSB Research	New Smyrna Beach	Florida
United States	Concorde Medical Group	New York	New York
United States	Cornell University	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	TrialSpark	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Local Institution - 087	Norman	Oklahoma
United States	Local Institution - 026	North Little Rock	Arkansas
United States	Local Institution - 060	North Massapequa	New York
United States	University of Massachusetts Memorial Medical Center	North Worcester	Massachusetts
United States	Local Institution - 005	Novi	Michigan
United States	Local Institution - 216	Oak Lawn	Illinois
United States	Alliance Clinical Research	Oceanside	California
United States	Digestive Disease Specialists	Oklahoma City	Oklahoma
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	Local Institution - 208	Oklahoma City	Oklahoma
United States	Local Institution - 294	Oklahoma City	Oklahoma
United States	Clinnova	Orange	California
United States	Local Institution - 212	Orangeburg	South Carolina
United States	Circuit Clinical	Orchard Park	New York
United States	Local Institution - 076	Orlando	Florida
United States	Omega Research Maitland, LLC	Orlando	Florida
United States	Local Institution - 002	Palmetto Bay	Florida
United States	Palo Alto Center-Palo Alto Medical Foundation Research Institute	Palo Alto	California
United States	Accurate Clinical Research Inc	Pasadena	Texas
United States	Havana Research Institute LLC	Pasadena	California
United States	Holland Center for Family Health	Peoria	Arizona
United States	Summit Clinical Research, LLC	Petersburg	Virginia
United States	Local Institution - 000	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Theia Clinical Research, LLC	Pinellas Park	Florida
United States	Local Institution - 098	Port Orange	Florida
United States	Local Institution - 113	Portland	Oregon
United States	University of Gastroenterology	Providence	Rhode Island
United States	M3 Wake Research Inc	Raleigh	North Carolina
United States	The Gastroenterology Group	Reston	Virginia
United States	Local Institution - 006	Rialto	California
United States	Local Institution - 071	Richardson	Texas
United States	Local Institution - 072	Richmond	Virginia
United States	Local Institution - 292	Riverton	Utah
United States	Local Institution - 172	Roanoke	Virginia
United States	Local Institution - 045	Rochester	Minnesota
United States	Sutter Medical Group	Roseville	California
United States	UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit	Sacramento	California
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	University Of Utah School Of Medicine	Salt Lake City	Utah
United States	San Antonio Gastroenterology	San Antonio	Texas
United States	Southern Star Research Institute LLC	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	Medical Associates Research Group	San Diego	California
United States	Local Institution - 281	San Francisco	California
United States	HonorHealth Research Institute	Scottsdale	Arizona
United States	University Of Washington Medical Center	Seattle	Washington
United States	Local Institution - 108	Southfield	Michigan
United States	Texas Digestive Disease Consultants - Southlake	Southlake	Texas
United States	Local Institution - 125	Spokane	Washington
United States	Local Institution - 286	Springfield	Massachusetts
United States	Penn State University Milton S Hershey Medical Center	State College	Pennsylvania
United States	Virginia Gastroenterology Institute PC	Suffolk	Virginia
United States	Precision Clinical Research, LLC.	Sunrise	Florida
United States	Apex Clinical Research	Tampa	Florida
United States	International Center for Research	Tampa	Florida
United States	Local Institution - 107	Tampa	Florida
United States	University Of South Florida	Tampa	Florida
United States	USF Health	Tampa	Florida
United States	Local Institution - 181	Temple	Texas
United States	Local Institution - 070	Topeka	Kansas
United States	Allergy, Asthma and Immunology Center, PC	Tulsa	Oklahoma
United States	Essential Medical Research, LLC	Tulsa	Oklahoma
United States	Local Institution - 073	Tyler	Texas
United States	Advanced Gastroenterology	Union City	Tennessee
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Great Lakes Medical Research, LLC	Warren	Ohio
United States	Local Institution - 114	Weeki Wachee	Florida
United States	New Hope Research Development	West Covina	California
United States	TPMG Clinical Research	Williamsburg	Virginia
United States	Local Institution - 052	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts
United States	West Michigan Clinical Research Center	Wyoming	Michigan
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Finland,  France,  Georgia,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Moldova, Republic of,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Senegal,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with a CDAI score of < 150	The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinicalactivity of CD	Up to 264 Weeks
Secondary	Proportion of participants with a simple endoscopy score (SES-CD) decrease from baseline of = 50%		Up to 264 Weeks
Secondary	Proportion of participants with average daily abdominal pain score = 1 point, and average daily stool frequency = 3 points with abdominal pain and stool frequency no worse than baseline		Up to 264 Weeks
Secondary	Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score of < 150		Up to 264 Weeks
Secondary	Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10%		Up to 264 Weeks
Secondary	Proportion of participants with CDAI reduction from baseline of = 70 points		Up to 264 Weeks
Secondary	Change from baseline in CDAI		Up to 264 Weeks
Secondary	Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score of < 150 and SES-CD decrease from baseline of = 50%		Up to 264 Weeks
Secondary	Proportion of participants with CDAI score of < 150 and SES-CD = 4 points and a SES-CD decrease = 2 points		Up to 264 Weeks
Secondary	Proportion of participants with average daily abdominal pain score = 1 point and average daily stool frequency = 3 points with abdominal pain and stool frequency no worse than baseline and SES-CD = 4 points and a SES-CD decrease = 2 points		Up to 264 Weeks
Secondary	Proportion of participants with SES-CD = 4 points and a SES-CD decrease = 2 points		Up to 264 Weeks
Secondary	Proportion of participants with a CDAI score < 150 in participants off corticosteroids		Up to 264 Weeks
Secondary	Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50%		Up to 264 Weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting