Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

NCT ID: NCT03440385

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 606 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2023-11-21

Brief Summary

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Conditions

Crohn Disease

Keywords

Crohn's Disease; Crohn Disease; Oral; Ozanimod; Moderately active; Severely active; RPC01; RPC01-3202

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Administration of oral Ozanimod

Group Type: EXPERIMENTAL

Ozanimod

Intervention Type: DRUG

Specified dose on specified days

Administration of Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Specified dose on specified days

Interventions

Ozanimod

Specified dose on specified days

Intervention Type: DRUG

Placebo

Specified dose on specified days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Crohn's disease for ≥ 3 months on endoscopy and on histological exam
• Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
• Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
• Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
• Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria

• Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
• Extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
• Current stoma, ileal-anal pouch anastomosis, or fistula

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 202

Scottsdale, Arizona, United States

Ucsd Medical Center

La Jolla, California, United States

Local Institution - 010

Lancaster, California, United States

Southern California Research Institute Medical Group, Inc.

Los Angeles, California, United States

Matrix Clinical Research Inc

Los Angeles, California, United States

Facey Medical Foundation (Parent)

Mission Hills, California, United States

Local Institution - 093

Pasadena, California, United States

Sutter Medical Group

Roseville, California, United States

Local Institution - 280

Sacramento, California, United States

Local Institution - 281

San Francisco, California, United States

Local Institution - 124

West Covina, California, United States

Local Institution - 065

Colorado Springs, Colorado, United States

Local Institution - 182

Bristol, Connecticut, United States

Local Institution - 166

Clearwater, Florida, United States

Local Institution - 084

Clermont, Florida, United States

American Research Institute Inc

Cutler Bay, Florida, United States

Local Institution - 112

Doral, Florida, United States

Riverside Clinical Research

Edgewater, Florida, United States

SIH Research

Kissimmee, Florida, United States

Local Institution - 067

Lighthouse PT, Florida, United States

Center For Advanced Gastroenterology

Maitland, Florida, United States

LMG Research

Miami, Florida, United States

Local Institution - 175

Miami, Florida, United States

Local Institution - 081

Miami, Florida, United States

Local Institution - 044

Miami Springs, Florida, United States

Local Institution - 192

New Port Richey, Florida, United States

Local Institution - 200

Orlando, Florida, United States

Local Institution - 002

Palmetto Bay, Florida, United States

Theia Clinical Research, LLC

Pinellas Park, Florida, United States

Precision Clinical Research, LLC.

Sunrise, Florida, United States

Local Institution - 183

Tampa, Florida, United States

Apex Clinical Research

Tampa, Florida, United States

Local Institution - 107

Tampa, Florida, United States

Local Institution - 037

Atlanta, Georgia, United States

Local Institution - 220

Atlanta, Georgia, United States

Local Institution - 143

Decatur, Georgia, United States

Local Institution - 115

Idaho Falls, Idaho, United States

Local Institution - 022

Chicago, Illinois, United States

Local Institution - 092

Evansville, Indiana, United States

Local Institution - 033

Indianapolis, Indiana, United States

Local Institution - 070

Topeka, Kansas, United States

Local Institution - 020

Baton Rouge, Louisiana, United States

Clinical Trials of SW Louisiana LLC

Lake Charles, Louisiana, United States

Tandem Clinical Research, LLC

Marrero, Louisiana, United States

Local Institution - 024

Worcester, Massachusetts, United States

Local Institution - 167

Kalamazoo, Michigan, United States

Local Institution - 005

Novi, Michigan, United States

Local Institution - 095

Minneapolis, Minnesota, United States

Local Institution - 045

Rochester, Minnesota, United States

Local Institution - 198

Kansas City, Missouri, United States

Internal Medicine Specialists

Las Vegas, Nevada, United States

Local Institution - 040

Lebanon, New Hampshire, United States

Local Institution - 054

Hartsdale, New York, United States

Weill Cornell Medical College

New York, New York, United States

Concorde Medical Group

New York, New York, United States

TrialSpark

New York, New York, United States

Local Institution - 060

North Massapequa, New York, United States

Local Institution - 156

Charlotte, North Carolina, United States

Local Institution - 052

Winston-Salem, North Carolina, United States

Local Institution - 170

Dayton, Ohio, United States

Local Institution - 049

Hilliard, Ohio, United States

Paramount Medical Research & Consulting, Llc

Middleburg Heights, Ohio, United States

Local Institution - 087

Norman, Oklahoma, United States

Local Institution - 294

Oklahoma City, Oklahoma, United States

Local Institution - 185

Tulsa, Oklahoma, United States

Local Institution - 217

Tulsa, Oklahoma, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Local Institution - 034

Fort Sam Houston, Texas, United States

Local Institution - 079

Houston, Texas, United States

Local Institution - 196

Houston, Texas, United States

Gulf Coast Research Group LLC

Houston, Texas, United States

Accurate Clinical Research Inc

Pasadena, Texas, United States

Local Institution - 071

Richardson, Texas, United States

Local Institution - 178

San Antonio, Texas, United States

Local Institution - 181

Temple, Texas, United States

Local Institution - 292

Riverton, Utah, United States

Local Institution - 030

Lynchburg, Virginia, United States

The Gastroenterology Group

Reston, Virginia, United States

Local Institution - 072

Richmond, Virginia, United States

Local Institution - 172

Roanoke, Virginia, United States

Local Institution - 089

La Crosse, Wisconsin, United States

Local Institution - 309

Liverpool, New South Wales, Australia

Local Institution - 318

New Lambton Heights, New South Wales, Australia

Local Institution - 328

Herston, Queensland, Australia

Local Institution - 313

Maroorchydore, Queensland, Australia

Local Institution - 321

North Mackay, Queensland, Australia

Local Institution - 312

South Brisbane, Queensland, Australia

Local Institution - 307

Bedford Park, South Australia, Australia

Local Institution - 326

Elizabeth Vale, South Australia, Australia

Local Institution - 317

Clayton, Victoria, Australia

Local Institution - 305

Fitzroy, Victoria, Australia

Local Institution - 329

Geelong, Victoria, Australia

Local Institution - 327

Melbourne, Victoria, Australia

Local Institution - 315

Subiaco, Western Australia, Australia

Local Institution - 726

Innsbruck, , Austria

Local Institution - 727

Sankt Pölten, , Austria

Local Institution - 336

Vienna, , Austria

Local Institution - 725

Vienna, , Austria

Local Institution - 753

Rousse, , Bulgaria

Local Institution - 750

Sofia, , Bulgaria

Local Institution - 755

Sofia, , Bulgaria

Local Institution - 756

Sofia, , Bulgaria

Local Institution - 752

Sofia, , Bulgaria

Local Institution - 554

Sofia, , Bulgaria

Local Institution - 269

Edmonton, Alberta, Canada

Local Institution - 262

New Westminster, British Columbia, Canada

Local Institution - 267

Vancouver, British Columbia, Canada

Local Institution - 256

Brandon, Manitoba, Canada

Local Institution - 266

Greater Sudbury, Ontario, Canada

Local Institution - 264

Toronto, Ontario, Canada

Local Institution - 257

Toronto, Ontario, Canada

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Montreal, Quebec, Canada

Local Institution - 270

Ottawa, Quebec, Canada

Local Institution - 423

Changzhou, Jiangsu, China

Local Institution - 369

Shanghai, Shanghai Municipality, China

Local Institution - 482

Beijing, , China

Local Institution - 467

Beijing, , China

Local Institution - 379

Bengbu, , China

Local Institution - 485

Changchun, , China

Local Institution - 376

Changchun, , China

Local Institution - 421

Changsha, , China

Local Institution - 378

Changsha, , China

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Changzhou, , China

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Chengdu, , China

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Fuzhou, , China

Local Institution - 478

Guangzhou, , China

Local Institution - 472

Guangzhou, , China

Local Institution - 486

Guangzhou, , China

Local Institution - 470

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 - 418

Nanjing, , China

Local Institution - 375

Nanjing, , China

Local Institution - 487

Nanjing, , China

Local Institution - 473

Shanghai, , China

Local Institution - 380

Shanghai, , China

Local Institution - 377

Shanghai, , China

Local Institution - 458

Taichung City, , China

Local Institution - 373

Tianjin, , China

Local Institution - 475

Wuhan, , China

Local Institution - 474

Wuhan, , China

Local Institution - 483

Wuhan, , China

Local Institution - 381

Wuxi, , China

Local Institution - 415

Xi'an, , China

Local Institution - 420

Xi'an, , China

Local Institution - 370

Zhengzhou, , China

Local Institution - 397

Armenia, , Colombia

Local Institution - 398

Barranquilla, , Colombia

Local Institution - 395

Bogotá, , Colombia

Local Institution - 396

Cali, , Colombia

Local Institution - 394

Medellín, , Colombia

Local Institution - 613

Helsinki, , Finland

Local Institution - 614

Turku, , Finland

Local Institution - 647

Neuilly-sur-Seine, Cedex, France

Local Institution - 639

Béziers, , France

Local Institution - 635

Blois, , France

Local Institution - 634

Caen, , France

Local Institution - 644

Colombes, , France

Local Institution - 632

Nantes, , France

Local Institution - 630

Pierre-Bénite, , France

Local Institution - 631

Saint-Priest-en-Jarez, , France

Local Institution - 786

Batumi, , Georgia

Local Institution - 779

Kutaisi, , Georgia

Local Institution - 454

Tbilisi, , Georgia

Local Institution - 778

Tbilisi, , Georgia

Local Institution - 782

Tbilisi, , Georgia

Local Institution - 552

Tbilisi, , Georgia

Local Institution - 793

Tbilisi, , Georgia

Local Institution - 740

Tbilisi, , Georgia

Local Institution - 783

Tbilisi, , Georgia

Local Institution - 784

Tbilisi, , Georgia

Local Institution - 785

Tbilisi, , Georgia

Local Institution - 335

Tbilisi, , Georgia

Local Institution - 455

Tbilisi, , Georgia

Local Institution - 781

Tbilisi, , Georgia

Local Institution - 780

Telavi, , Georgia

Local Institution - 629

Berlin, , Germany

Local Institution - 653

Berlin, , Germany

Local Institution - 648

Berlin, , Germany

Local Institution - 628

Berlin, , Germany

Local Institution - 664

Brandenburg, , Germany

Local Institution - 732

Dachau, , Germany

Local Institution - 574

Frankfurt am Main, , Germany

Local Institution - 657

Frankfurt am Main, , Germany

Local Institution - 658

Halle, , Germany

Local Institution - 656

Halle, , Germany

Local Institution - 652

Hamburg, , Germany

Local Institution - 591

Hanover, , Germany

Local Institution - 649

Keil, , Germany

Local Institution - 337

Leipzig, , Germany

Local Institution - 660

Mainz, , Germany

Local Institution - 667

Münster, , Germany

Local Institution - 620

Neuruppin, , Germany

Local Institution - 584

Nürtingen, , Germany

Local Institution - 661

Stuttgart, , Germany

Local Institution - 790

Athens, , Greece

Local Institution - 588

Athens, , Greece

Local Institution - 791

Athens, , Greece

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Athens, , Greece

Local Institution - 592

Athens, Attiki, , Greece

Local Institution - 787

Heraklion, , Greece

Local Institution - 789

Thessaloniki, , Greece

Local Institution - 788

Thessaloniki, , Greece

Local Institution - 404

Hong Kong, , Hong Kong

Local Institution - 405

Kowloon, , Hong Kong

Local Institution - 798

Békéscsaba, , Hungary

Local Institution - 803

Budapest, , Hungary

Local Institution - 804

Budapest, , Hungary

Local Institution - 556

Budapest, , Hungary

Local Institution - 801

Győr, , Hungary

Local Institution - 555

Gyula, , Hungary

Local Institution - 797

Miskolc, , Hungary

Local Institution - 800

Nagykanizsa, , Hungary

Local Institution - 816

Szekszárd, , Hungary

Local Institution - 805

Szentes, , Hungary

Local Institution - 799

Székesfehérvár, , Hungary

Local Institution - 343

Afula, , Israel

Local Institution - 346

Beer Jacob, , Israel

Local Institution - 350

Haifa, , Israel

Local Institution - 347

Jerusalem, , Israel

Local Institution - 349

Kfar Saba, , Israel

Local Institution - 341

Petah Tikva, , Israel

Local Institution - 340

Tel Aviv, , Israel

Local Institution - 605

Kaunas, , Lithuania

Local Institution - 603

Klaipėda, , Lithuania

Local Institution - 607

Vilnius, , Lithuania

Local Institution - 606

Vilnius, , Lithuania

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Vilnius, , Lithuania

Local Institution - 952

Amsterdam, , Netherlands

Local Institution - 955

Amsterdam, , Netherlands

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Groningen, , Netherlands

Local Institution - 949

Nijmegen, , Netherlands

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Sittard-Geleen, , Netherlands

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Tilburg, , Netherlands

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Częstochowa, , Poland

Local Institution - 988

Elblag, , Poland

Local Institution - 579

Gdansk, , Poland

Local Institution - 978

Gdansk, , Poland

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Gdynia, , Poland

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Jelenia Góra, , Poland

Local Institution - 757

Józefów, , Poland

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Katowice, , Poland

Local Institution - 834

Ksawerów, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Nowy Targ, , Poland

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Rzeszów, , Poland

Local Institution - 979

Sopot, , Poland

Local Institution - 835

Szczecin, , Poland

Local Institution - 586

Warsaw, , Poland

Local Institution - 833

Warsaw, , Poland

Local Institution - 989

Warsaw, , Poland

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Warsaw, , Poland

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Wierzchosławice, , Poland

Local Institution - 983

Wroclaw, , Poland

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Wroclaw, , Poland

Local Institution - 582

Wroclaw, , Poland

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Wroclaw, , Poland

Local Institution - 831

Wroclaw, , Poland

Local Institution - 987

Wroclaw, , Poland

Local Institution - 832

Wroclaw, , Poland

Local Institution - 959

Coimbra, , Portugal

Local Institution - 958

Guimarães, , Portugal

Local Institution - 961

Loures, , Portugal

Local Institution - 957

Viana do Castelo, , Portugal

Local Institution - 966

Barnaul, , Russia

Local Institution - 871

Barnaul, , Russia

Local Institution - 589

Bataysk, , Russia

Local Institution - 621

Chelyabinsk, , Russia

Local Institution - 991

Chelyabinsk, , Russia

Local Institution - 998

Kaliningrad, , Russia

Local Institution - 882

Kaluga, , Russia

Local Institution - 849

Kemerovo, , Russia

Local Institution - 566

Moscow, , Russia

Local Institution - 995

Moscow, , Russia

Local Institution - 873

Moscow, , Russia

Local Institution - 870

Moscow, , Russia

Local Institution - 869

Moscow, , Russia

Local Institution - 990

Nizhny Novgorod, , Russia

Local Institution - 853

Novosibirsk, , Russia

Local Institution - 876

Novosibirsk, , Russia

Local Institution - 996

Omsk, , Russia

Local Institution - 875

Orenburg, , Russia

Local Institution - 867

Penza, , Russia

Local Institution - 863

Saint Petersburg, , Russia

Local Institution - 993

Saint Petersburg, , Russia

Local Institution - 868

Saint Petersburg, , Russia

Local Institution - 857

Saint Petersburg, , Russia

Local Institution - 879

Saint Petersburg, , Russia

Local Institution - 878

Saint Petersburg, , Russia

Local Institution - 874

Saint Petersburg, , Russia

Local Institution - 865

Samara, , Russia

Local Institution - 992

Saratov, , Russia

Local Institution - 866

Sochi, , Russia

Local Institution - 877

Tomsk, , Russia

Local Institution - 881

Ufa, , Russia

Local Institution - 880

Volgograd, , Russia

Local Institution - 583

Yekaterinburg, , Russia

Local Institution - 872

Yekaterinburg, , Russia

Local Institution - 546

Cape Town, , Senegal

Local Institution - 887

Belgrade, , Serbia

Local Institution - 596

Belgrade, , Serbia

Local Institution - 886

Belgrade, , Serbia

Local Institution - 890

Belgrade, , Serbia

Local Institution - 891

Kragujevac, , Serbia

Local Institution - 884

Novi Sad, , Serbia

Local Institution - 885

Pančevo, , Serbia

Local Institution - 585

Vršac, , Serbia

Local Institution - 889

Zrenjanin, , Serbia

Local Institution - 900

Bratislava, , Slovakia

Local Institution - 894

Bratislava, , Slovakia

Local Institution - 895

Brezno, , Slovakia

Local Institution - 899

Nitra, , Slovakia

Local Institution - 897

Nové Zámky, , Slovakia

Local Institution - 898

Prešov, , Slovakia

Local Institution - 896

Rimavská Sobota, , Slovakia

Local Institution - 904

Celje, , Slovenia

Local Institution - 543

Gauteng, , South Africa

Local Institution - 545

Kempton Park, , South Africa

Local Institution - 544

Pretoria, , South Africa

Local Institution - 542

Pretoria, , South Africa

Local Institution - 549

Pretoria, , South Africa

Local Institution - 548

Somerset West, , South Africa

Local Institution - 547

Val de Grace, , South Africa

Local Institution - 434

Busan, , South Korea

Local Institution - 431

Busan, , South Korea

Local Institution - 432

Daegu, , South Korea

Local Institution - 438

Seoul, , South Korea

Local Institution - 429

Suwon, , South Korea

Teknon Medical Center

Barcelona, , Spain

University Hospital Reina Sofia

Córdoba, , Spain

University Hospital of Girona Dr. Josep Trueta

Girona, , Spain

Hospital Universitario De Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, , Spain

Local Institution - 695

Madrid, , Spain

University Hospital Puerta de Hierro Majadajonda

Majadahonda, Madrid, , Spain

University Hospital Marques de Valdecilla (HUMV)

Santander, , Spain

Local Institution - 697

Valencia, , Spain

Local Institution - 625

Stockholm, , Sweden

Local Institution - 460

Kaohsiung City, , Taiwan

Local Institution - 463

Kaohsiung, San Ming Dist., , Taiwan

Local Institution - 461

Niao-Sung Hsiang Kaohsiung County, , Taiwan

Local Institution - 459

Tainan, Taiana, , Taiwan

Local Institution - 462

Taoyuan, , Taiwan

Local Institution - 464

Tapei, Beitou Dist., , Taiwan

Local Institution - 465

Tapei, , Taiwan

Local Institution - 357

Ankara, , Turkey (Türkiye)

Local Institution - 365

Elâzığ, , Turkey (Türkiye)

Local Institution - 358

Istanbul, , Turkey (Türkiye)

Local Institution - 361

Istanbul, , Turkey (Türkiye)

Local Institution - 353

Kadiköy/Istanbul, , Turkey (Türkiye)

Local Institution - 922

Chernivtsi, , Ukraine

Local Institution - 929

Ivano-Frankivsk, , Ukraine

Local Institution - 965

Kharkiv, , Ukraine

Local Institution - 920

Khmelnytskyi, , Ukraine

Local Institution - 933

Kropyvnytskyi, , Ukraine

Local Institution - 923

Kyiv, , Ukraine

Local Institution - 563

Kyiv, , Ukraine

Local Institution - 564

Kyiv, , Ukraine

Local Institution - 977

Kyiv, , Ukraine

Local Institution - 590

Lutsk, , Ukraine

Local Institution - 974

Lviv, , Ukraine

Local Institution - 902

Odesa, , Ukraine

Local Institution - 932

Vinnytsia, , Ukraine

Local Institution - 924

Vinnytsia, , Ukraine

Local Institution - 587

Zaporizhia, , Ukraine

Local Institution - 925

Zaporizhzhya, , Ukraine

Countries

Brazil; United States; Australia; Austria; Bulgaria; Canada; China; Colombia; Finland; France; Georgia; Germany; Greece; Hong Kong; Hungary; Israel; Lithuania; Netherlands; Poland; Portugal; Russia; Senegal; Serbia; Slovakia; Slovenia; South Africa; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); Ukraine

References

Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Nov;122:106958. doi: 10.1016/j.cct.2022.106958. Epub 2022 Oct 5.

Reference Type: DERIVED

PMID: 36208720 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

U1111-1203-7949

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-004293-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RPC01-3202

Identifier Type: -

Identifier Source: org_study_id