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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified October 2024 by Celgene
Sponsor
Celgene
Information Provided by (Responsible Party)
Celgene
Clinicaltrials.gov Identifier
NCT03440385
Other Study ID Numbers:
RPC01-3202
First Submitted
February 13, 2018
First Posted
February 21, 2018
Results First Posted
November 10, 2024
Last Update Posted
December 4, 2024
Last Verified
October 2024

ClinicalTrials.gov processed this data on November 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Crohn Disease
Drug: OzanimodOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment606 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleInduction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Study Start DateMarch 6, 2018
Actual Primary Completion DateNovember 20, 2023
Actual Study Completion DateNovember 20, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Administration of oral Ozanimod
Drug: Ozanimod
Specified dose on specified days
Administration of Placebo
Other: Placebo
Specified dose on specified days

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150
    The CDAI is a composite score that is used to measure the clinical activity of Crohn&#039;s disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Secondary Outcome Measures
  1. Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission
    Abdominal pain and stool frequency clinical remission was defined as average daily abdominal pain score &le; 1 point, and average daily stool frequency &le; 3 with abdominal pain and stool frequency no worse than baseline at Week 12. Participants entered the responses in diaries daily. The 7 days entries prior to Week 12 visit were considered for calculating average abdominal pain score and stool frequency. The abdominal pain was graded on severity of 0 (none) to 3 (severe) scale and stool frequency was defined number of liquid or soft stools per day. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
  2. Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%
    The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
  3. Percentage of Participants With Reduction From Baseline in the Crohn's Disease Activity Index (CDAI) Score of >= 100 Points or a Total CDAI Score < 150
    The CDAI is a composite score that is used to measure the clinical activity of Crohn&#039;s disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
  4. Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and SES-CD Decrease From Baseline of ≥ 50%
    CDAI include 8 components number of soft/liquid stools, severity of abdominal pain, wellbeing, complications, need antidiarrheal drugs, abdominal mass, hematocrit, deviation in body wt. Subscores of numbers of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to visit. The others weighted to create the total CDAI score ranging 0-600 with higher score indicating worse outcome. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.
  5. Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%
    CDAI include 8 components number of soft/liquid stools, severity of abdominal pain, wellbeing, complications, need antidiarrheal drugs, abdominal mass, hematocrit, deviation in body wt. Subscores of numbers of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to visit. The others weighted to create the total CDAI score ranging 0-600 with higher score indicating worse outcome. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.
  6. Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission and a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score <= 4 Points and Decrease >= 2 Points
    Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score &le; 1 point, and average daily stool frequency &le; 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. The SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). In SES-CD, each of 4 components are assessed in the five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.
  7. Percentage of Participants With Global Histologic Activity Score (GHAS) Remission
    GHAS assesses the inflammation and mucosal damage. GHAS has 8 components Epithelial damage, Architectural changes, Infiltration of mononuclear cells in the lamina propria, Infiltration of polymorphonuclear cells in the lamina propria, Polymorphonuclear cells in epithelium, Presence of erosion and/or ulcers, Presence of granuloma and number of biopsy specimens affected. Each of these components was scored on a scale of 0 (none/unaffected) to 2 (worst). Each of these 8 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. Within each segment, the GHAS score has a range of 0 - 16, and the total GHAS score has a range of 0 - 80. Higher numbers correspond to more inflammation and more mucosal damage. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
  8. Percentage of Participants With CDAI Reduction From Baseline of >=70 Points
    The CDAI is a composite score that is used to measure the clinical activity of Crohn&#039;s disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Baseline was defined as the last assessment prior to the start time of the first drug administration if time of measurement is available else the last assessment prior to or on the date of the first drug administration.
  9. Percentage of Participants With Absence of Ulcers ≥ 0.5 cm With no Segment With Any Ulcerated Surface ≥10%
    The ulcerated surface were assessed via endoscopy.
  10. Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50%
    CDEIS is an index for determining the severity of Crohn&#039;s disease with endoscopic localization to ileum and colon. The CDEIS divides the intestine into 5 segments: rectum, sigmoid and left colon, transverse colon, right colon, and ileum. Four variables are assessed in each segment: the presence of deep ulceration, the presence of superficial ulceration, the percentage of ulcerated surface, and the percentage of surface affected by CD, indicated on 10-cm visual analogue scales. In addition, the presence of ulcerated stenosis and the presence of nonulcerated stenosis are also assessed over the entire intestine. These factors are weighted and summed to calculate the total score ranging from 0- 44, with higher scores indicating more severe disease.
  11. Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission and an Endoscopic (50%) Response
    AP and SF clinical remission is average daily abdominal pain score &le; 1 point, and average daily stool frequency &le; 3 times with AP and SF no worse than baseline at Week 12. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. SES-CD has 4 components size of ulcers, ulcerated surface, affected surface, presence of narrowing. Each component was scored on scale of 0 (none) to 3 (worst). Endoscopic Response is defined as \&gt;= 50% decrease from baseline in SES-CD. In SES-CD, each of 4 components are assessed in five segments: ileum, right, transverse, left colon, and rectum. The SES-CD was sum of individual scores of each of components across five segments. Range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for overall, with larger scores show greater degree of inflammation.
  12. Percentage of Participants With Robarts Histologic Index (RHI) Mucosal Healing at Week 12
    RHI mucosal healing was defined as RHI remission combined with SES-CD \&lt;= 4 points and a SES-CD decrease from baseline \&gt;= 2 points with no SES-CD sub-score \&gt;1 point. RHI Remission is defined as no active inflammation in any measured segment. The SES-CD assesses the following 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater degree of inflammation.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Sponsors and CollaboratorsCelgene
Locations
Local Institution - 202 | Scottsdale Arizona, United States, 85258Ucsd Medical Center | La Jolla California, United States, 92037Local Institution - 010 | Lancaster California, United States, 93534Southern California Research Institute Medical Group, Inc. | Los Angeles California, United States, 90045Matrix Clinical Research Inc | Los Angeles California, United States, 90048Facey Medical Foundation (Parent) | Mission Hills California, United States, 91345Local Institution - 093 | Pasadena California, United States, 91105Sutter Medical Group | Roseville California, United States, 95661Local Institution - 280 | Sacramento California, United States, 95817Local Institution - 281 | San Francisco California, United States, 94158Local Institution - 124 | West Covina California, United States, 91790Local Institution - 065 | Colorado Springs Colorado, United States, 80907Local Institution - 182 | Bristol Connecticut, United States, 06010Local Institution - 166 | Clearwater Florida, United States, 33765Local Institution - 084 | Clermont Florida, United States, 34711American Research Institute Inc | Cutler Bay Florida, United States, 33157Local Institution - 112 | Doral Florida, United States, 33166Riverside Clinical Research | Edgewater Florida, United States, 32132SIH Research | Kissimmee Florida, United States, 34759Local Institution - 067 | Lighthouse PT Florida, United States, 33064Center For Advanced Gastroenterology | Maitland Florida, United States, 32751LMG Research | Miami Florida, United States, 33125Local Institution - 175 | Miami Florida, United States, 33166Local Institution - 081 | Miami Florida, United States, 33176Local Institution - 044 | Miami Springs Florida, United States, 33166Local Institution - 192 | New Port Richey Florida, United States, 34655Local Institution - 200 | Orlando Florida, United States, 32810Local Institution - 002 | Palmetto Bay Florida, United States, 33157Theia Clinical Research, LLC | Pinellas Park Florida, United States, 33781Precision Clinical Research, LLC. | Sunrise Florida, United States, 33351Local Institution - 183 | Tampa Florida, United States, 33612-4799Apex Clinical Research | Tampa Florida, United States, 33612Local Institution - 107 | Tampa Florida, United States, 33614Local Institution - 037 | Atlanta Georgia, United States, 30322Local Institution - 220 | Atlanta Georgia, United States, 30322Local Institution - 143 | Decatur Georgia, United States, 30030Local Institution - 115 | Idaho Falls Idaho, United States, 83404Local Institution - 022 | Chicago Illinois, United States, 60637Local Institution - 092 | Evansville Indiana, United States, 47714Local Institution - 033 | Indianapolis Indiana, United States, 46202Local Institution - 070 | Topeka Kansas, United States, 66606Local Institution - 020 | Baton Rouge Louisiana, United States, 70809Clinical Trials of SW Louisiana LLC | Lake Charles Louisiana, United States, 70601Tandem Clinical Research, LLC | Marrero Louisiana, United States, 70072Local Institution - 024 | Worcester Massachusetts, United States, 01655Local Institution - 167 | Kalamazoo Michigan, United States, 49008Local Institution - 005 | Novi Michigan, United States, 48377Local Institution - 095 | Minneapolis Minnesota, United States, 55455Local Institution - 045 | Rochester Minnesota, United States, 55905Local Institution - 198 | Kansas City Missouri, United States, 64111Internal Medicine Specialists | Las Vegas Nevada, United States, 89145Local Institution - 040 | Lebanon New Hampshire, United States, 03756Local Institution - 054 | Hartsdale New York, United States, 10530Weill Cornell Medical College | New York New York, United States, 10010Concorde Medical Group | New York New York, United States, 10016TrialSpark | New York New York, United States, 10024Local Institution - 060 | North Massapequa New York, United States, 11758-1802Local Institution - 156 | Charlotte North Carolina, United States, 28209Local Institution - 052 | Winston-Salem North Carolina, United States, 27103Local Institution - 170 | Dayton Ohio, United States, 45417Local Institution - 049 | Hilliard Ohio, United States, 43026Paramount Medical Research & Consulting, Llc | Middleburg Heights Ohio, United States, 44130Local Institution - 087 | Norman Oklahoma, United States, 73071Local Institution - 294 | Oklahoma City Oklahoma, United States, 73102Local Institution - 185 | Tulsa Oklahoma, United States, 74136Local Institution - 217 | Tulsa Oklahoma, United States, 74137University of Pennsylvania Cancer Center | Philadelphia Pennsylvania, United States, 19104Local Institution - 034 | Fort Sam Houston Texas, United States, 78234Local Institution - 079 | Houston Texas, United States, 77058Local Institution - 196 | Houston Texas, United States, 77089Gulf Coast Research Group LLC | Houston Texas, United States, 77098Accurate Clinical Research Inc | Pasadena Texas, United States, 77505Local Institution - 071 | Richardson Texas, United States, 75082Local Institution - 178 | San Antonio Texas, United States, 78229Local Institution - 181 | Temple Texas, United States, 76508Local Institution - 292 | Riverton Utah, United States, 84065Local Institution - 030 | Lynchburg Virginia, United States, 24502The Gastroenterology Group | Reston Virginia, United States, 20191Local Institution - 072 | Richmond Virginia, United States, 23249Local Institution - 172 | Roanoke Virginia, United States, 24016Local Institution - 089 | La Crosse Wisconsin, United States, 54601Local Institution - 309 | Liverpool New South Wales, Australia, 2170Local Institution - 318 | New Lambton Heights New South Wales, Australia, 2305Local Institution - 328 | Herston Queensland, Australia, 4029Local Institution - 313 | Maroorchydore Queensland, Australia, 4558Local Institution - 321 | North Mackay Queensland, Australia, 4740Local Institution - 312 | South Brisbane Queensland, Australia, 4101Local Institution - 307 | Bedford Park South Australia, Australia, 5042Local Institution - 326 | Elizabeth Vale South Australia, Australia, 05112Local Institution - 317 | Clayton Victoria, Australia, 3168Local Institution - 305 | Fitzroy Victoria, Australia, 3065Local Institution - 329 | Geelong Victoria, Australia, 3220Local Institution - 327 | Melbourne Victoria, Australia, 3004Local Institution - 315 | Subiaco Western Australia, Australia, 6008Local Institution - 726 | Innsbruck , Austria, 6020Local Institution - 727 | Sankt Pölten , Austria, 3100Local Institution - 336 | Vienna , Austria, 1020Local Institution - 725 | Vienna , Austria, 1090Local Institution - 753 | Rousse , Bulgaria, 7002Local Institution - 750 | Sofia , Bulgaria, 1407Local Institution - 755 | Sofia , Bulgaria, 1407Local Institution - 756 | Sofia , Bulgaria, 1431Local Institution - 752 | Sofia , Bulgaria, 1527Local Institution - 554 | Sofia , Bulgaria, 1784Local Institution - 269 | Edmonton Alberta, Canada, T5R1W2Local Institution - 262 | New Westminster British Columbia, Canada, V3L 3W5Local Institution - 267 | Vancouver British Columbia, Canada, V6Z 2K5Local Institution - 256 | Brandon Manitoba, Canada, R7A 0N7Local Institution - 266 | Greater Sudbury Ontario, Canada, P3C 5K6Local Institution - 264 | Toronto Ontario, Canada, M5G 1X5Local Institution - 257 | Toronto Ontario, Canada, M5T 3A9Local Institution - 254 | Montreal Quebec, Canada, H1T 2M4Local Institution - 270 | Ottawa Quebec, Canada, K1H 8L6Local Institution - 423 | Changzhou Jiangsu, China, 213003Local Institution - 369 | Shanghai Shanghai Municipality, China, 200120Local Institution - 482 | Beijing , China, 100050Local Institution - 467 | Beijing , China, 100700Local Institution - 379 | Bengbu , China, 233004Local Institution - 485 | Changchun , China, 130021Local Institution - 376 | Changchun , China, 130033Local Institution - 421 | Changsha , China, 410008Local Institution - 378 | Changsha , China, 450052Local Institution - 414 | Changzhou , China, 213004Local Institution - 419 | Chengdu , China, 610041Local Institution - 422 | Fuzhou , China, 350005Local Institution - 478 | Guangzhou , China, 510030Local Institution - 472 | Guangzhou , China, 510180Local Institution - 486 | Guangzhou , China, 510655Local Institution - 470 | Hangzhou, Zhejiang , China, 100142Local Institution - 491 | Hefei , China, 230001Local Institution - 374 | Kunming , China, 650032Local Institution - 383 | Luzhou , China, 646099Local Institution - 488 | Nanchang , China, 330006Local Institution - 418 | Nanjing , China, 210008Local Institution - 375 | Nanjing , China, 210009Local Institution - 487 | Nanjing , China, 210029Local Institution - 473 | Shanghai , China, 200025Local Institution - 380 | Shanghai , China, 200040Local Institution - 377 | Shanghai , China, 200080Local Institution - 458 | Taichung City , China, 40447Local Institution - 373 | Tianjin , China, 300052Local Institution - 475 | Wuhan , China, 430022Local Institution - 474 | Wuhan , China, 430030Local Institution - 483 | Wuhan , China, 430060Local Institution - 381 | Wuxi , China, 214023Local Institution - 415 | Xi'an , China, 710038Local Institution - 420 | Xi'an , China, 710100Local Institution - 370 | Zhengzhou , China, 450014Local Institution - 397 | Armenia , Colombia, 630004Local Institution - 398 | Barranquilla , Colombia, 080020Local Institution - 395 | Bogotá , Colombia, 110221Local Institution - 396 | Cali , Colombia, 760026Local Institution - 394 | Medellín , Colombia, 050034Local Institution - 613 | Helsinki , Finland, 00290Local Institution - 614 | Turku , Finland, FI-20521Local Institution - 647 | Neuilly-sur-Seine Cedex, France, 92200Local Institution - 639 | Béziers , France, 34525Local Institution - 635 | Blois , France, 41016Local Institution - 634 | Caen , France, 14000Local Institution - 644 | Colombes , France, 92701Local Institution - 632 | Nantes , France, 44093Local Institution - 630 | Pierre-Bénite , France, 69495Local Institution - 631 | Saint-Priest-en-Jarez , France, 42270Local Institution - 786 | Batumi , Georgia, 6010Local Institution - 779 | Kutaisi , Georgia, 4600Local Institution - 454 | Tbilisi , Georgia, 0101Local Institution - 778 | Tbilisi , Georgia, 0112Local Institution - 782 | Tbilisi , Georgia, 0131Local Institution - 552 | Tbilisi , Georgia, 0144Local Institution - 793 | Tbilisi , Georgia, 0159Local Institution - 740 | Tbilisi , Georgia, 0160Local Institution - 783 | Tbilisi , Georgia, 0160Local Institution - 784 | Tbilisi , Georgia, 0160Local Institution - 785 | Tbilisi , Georgia, 0160Local Institution - 335 | Tbilisi , Georgia, 0179Local Institution - 455 | Tbilisi , Georgia, 0180Local Institution - 781 | Tbilisi , Georgia, 0186Local Institution - 780 | Telavi , Georgia, 2200Local Institution - 629 | Berlin , Germany, 10787Local Institution - 653 | Berlin , Germany, 12200Local Institution - 648 | Berlin , Germany, 13353Local Institution - 628 | Berlin , Germany, 14163Local Institution - 664 | Brandenburg an der Havel , Germany, 14770Local Institution - 732 | Dachau , Germany, 85221Local Institution - 574 | Frankfurt am Main , Germany, 60313Local Institution - 657 | Frankfurt am Main , Germany, 60590Local Institution - 658 | Halle , Germany, 06108Local Institution - 656 | Halle , Germany, 06120Local Institution - 652 | Hamburg , Germany, 22559Local Institution - 591 | Hanover , Germany, 30625Local Institution - 649 | Keil , Germany, 24105Local Institution - 337 | Leipzig , Germany, 04103Local Institution - 660 | Mainz , Germany, 55131Local Institution - 667 | Münster , Germany, 48149Local Institution - 620 | Neuruppin , Germany, 16816Local Institution - 584 | Nürtingen , Germany, 72622Local Institution - 661 | Stuttgart , Germany, 70376Local Institution - 790 | Athens , Greece, 11 527Local Institution - 588 | Athens , Greece, 115 28Local Institution - 791 | Athens , Greece, 11527Local Institution - 792 | Athens , Greece, 18536Local Institution - 592 | Athens, Attiki , Greece, 15562Local Institution - 787 | Heraklion , Greece, 71 110Local Institution - 789 | Thessaloniki , Greece, 54642Local Institution - 788 | Thessaloniki , Greece, 56429Local Institution - 404 | Hong Kong , Hong Kong, 0Local Institution - 405 | Kowloon , Hong Kong, 0Local Institution - 798 | Békéscsaba , Hungary, 5600Local Institution - 803 | Budapest , Hungary, 1062Local Institution - 804 | Budapest , Hungary, 1088Local Institution - 556 | Budapest , Hungary, H-1036Local Institution - 801 | Győr , Hungary, 9024Local Institution - 555 | Gyula , Hungary, 5700Local Institution - 797 | Miskolc , Hungary, 3529Local Institution - 800 | Nagykanizsa , Hungary, H-8800Local Institution - 816 | Szekszárd , Hungary, 7100Local Institution - 805 | Szentes , Hungary, 6600Local Institution - 799 | Székesfehérvár , Hungary, 8000Local Institution - 343 | Afula , Israel, 18341Local Institution - 346 | Beer Jacob , Israel, 73100Local Institution - 350 | Haifa , Israel, 3109601Local Institution - 347 | Jerusalem , Israel, 9362410Local Institution - 349 | Kfar Saba , Israel, 44281Local Institution - 341 | Petah Tikva , Israel, 49100Local Institution - 340 | Tel Aviv , Israel, 64239Local Institution - 605 | Kaunas , Lithuania, LT-50009Local Institution - 603 | Klaipėda , Lithuania, LT-5808Local Institution - 607 | Vilnius , Lithuania, 08406Local Institution - 606 | Vilnius , Lithuania, LT-08661Local Institution - 604 | Vilnius , Lithuania, LT-10207Local Institution - 952 | Amsterdam , Netherlands, 1081 HVLocal Institution - 955 | Amsterdam , Netherlands, 1105 AZLocal Institution - 956 | Groningen , Netherlands, 9713 GZLocal Institution - 949 | Nijmegen , Netherlands, 6525 GALocal Institution - 951 | Sittard-Geleen , Netherlands, 6162 BGLocal Institution - 954 | Tilburg , Netherlands, 5022 GCLocal Institution - 580 | Częstochowa , Poland, 42-202Local Institution - 988 | Elblag , Poland, 82-300Local Institution - 579 | Gdansk , Poland, 80-382Local Institution - 978 | Gdansk , Poland, 80-803Local Institution - 577 | Gdynia , Poland, 81-537Local Institution - 906 | Jelenia Góra , Poland, 58-500Local Institution - 757 | Józefów , Poland, 05-410Local Institution - 578 | Katowice , Poland, 40-040Local Institution - 834 | Ksawerów , Poland, 95-054Local Institution - 581 | Lodz , Poland, 90-127Local Institution - 981 | Lodz , Poland, 93-034Local Institution - 976 | Nowy Targ , Poland, 34-400Local Institution - 963 | Rzeszów , Poland, 35-302Local Institution - 979 | Sopot , Poland, 81-756Local Institution - 835 | Szczecin , Poland, 71-270Local Institution - 586 | Warsaw , Poland, 00-728Local Institution - 833 | Warsaw , Poland, 02-018Local Institution - 989 | Warsaw , Poland, 02-653Local Institution - 807 | Warsaw , Poland, 04-730Local Institution - 893 | Wierzchosławice , Poland, 33-122Local Institution - 983 | Wroclaw , Poland, 50-053Local Institution - 984 | Wroclaw , Poland, 50-367Local Institution - 582 | Wroclaw , Poland, 50-381Local Institution - 982 | Wroclaw , Poland, 51-162Local Institution - 831 | Wroclaw , Poland, 53-114Local Institution - 987 | Wroclaw , Poland, 53-333Local Institution - 832 | Wroclaw , Poland, 54-144Local Institution - 959 | Coimbra , Portugal, 3000-075Local Institution - 958 | Guimarães , Portugal, 4835-044Local Institution - 961 | Loures , Portugal, 2674-514Local Institution - 957 | Viana do Castelo , Portugal, 4904-858Local Institution - 966 | Barnaul , Russia, 656015Local Institution - 871 | Barnaul , Russia, 656024Local Institution - 589 | Bataysk , Russia, 346880Local Institution - 621 | Chelyabinsk , Russia, 454021Local Institution - 991 | Chelyabinsk , Russia, 454076Local Institution - 998 | Kaliningrad , Russia, 236016Local Institution - 882 | Kaluga , Russia, 248007Local Institution - 849 | Kemerovo , Russia, 650066Local Institution - 566 | Moscow , Russia, 105554Local Institution - 995 | Moscow , Russia, 115516Local Institution - 873 | Moscow , Russia, 117997Local Institution - 870 | Moscow , Russia, 119192Local Institution - 869 | Moscow , Russia, 123423Local Institution - 990 | Nizhny Novgorod , Russia, 603140Local Institution - 853 | Novosibirsk , Russia, 630091Local Institution - 876 | Novosibirsk , Russia, 630117Local Institution - 996 | Omsk , Russia, 644024Local Institution - 875 | Orenburg , Russia, 460050Local Institution - 867 | Penza , Russia, 440026Local Institution - 863 | Saint Petersburg , Russia, 191015Local Institution - 993 | Saint Petersburg , Russia, 191015Local Institution - 868 | Saint Petersburg , Russia, 194044Local Institution - 857 | Saint Petersburg , Russia, 195009Local Institution - 879 | Saint Petersburg , Russia, 196143Local Institution - 878 | Saint Petersburg , Russia, 196247Local Institution - 874 | Saint Petersburg , Russia, 197110Local Institution - 865 | Samara , Russia, 443001Local Institution - 992 | Saratov , Russia, 410053Local Institution - 866 | Sochi , Russia, 354207Local Institution - 877 | Tomsk , Russia, 634063Local Institution - 881 | Ufa , Russia, 450005Local Institution - 880 | Volgograd , Russia, 400107Local Institution - 583 | Yekaterinburg , Russia, 620075Local Institution - 872 | Yekaterinburg , Russia, 620109Local Institution - 546 | Cape Town , Senegal, 7500Local Institution - 887 | Belgrade , Serbia, 11 080Local Institution - 596 | Belgrade , Serbia, 11000Local Institution - 886 | Belgrade , Serbia, 11000Local Institution - 890 | Belgrade , Serbia, 11000Local Institution - 891 | Kragujevac , Serbia, 34000Local Institution - 884 | Novi Sad , Serbia, 21 000Local Institution - 885 | Pančevo , Serbia, 26000Local Institution - 585 | Vršac , Serbia, 26300Local Institution - 889 | Zrenjanin , Serbia, 23 000Local Institution - 900 | Bratislava , Slovakia, 820 07Local Institution - 894 | Bratislava , Slovakia, 82606Local Institution - 895 | Brezno , Slovakia, 97701Local Institution - 899 | Nitra , Slovakia, 94901Local Institution - 897 | Nové Zámky , Slovakia, 94002Local Institution - 898 | Prešov , Slovakia, 080 01Local Institution - 896 | Rimavská Sobota , Slovakia, 979 01Local Institution - 904 | Celje , Slovenia, 3000Local Institution - 543 | Gauteng , South Africa, 1820Local Institution - 545 | Kempton Park , South Africa, 1619Local Institution - 544 | Pretoria , South Africa, 0001Local Institution - 542 | Pretoria , South Africa, 0084Local Institution - 549 | Pretoria , South Africa, 0181Local Institution - 548 | Somerset West , South Africa, 7130Local Institution - 547 | Val de Grace , South Africa, 0184Local Institution - 434 | Busan , South Korea, 49241Local Institution - 431 | Busan , South Korea, 612-030Local Institution - 432 | Daegu , South Korea, 705-030Local Institution - 438 | Seoul , South Korea, 3080Local Institution - 429 | Suwon , South Korea, 442723Teknon Medical Center | Barcelona , Spain, 08022University Hospital Reina Sofia | Córdoba , Spain, 14001University Hospital of Girona Dr. Josep Trueta | Girona , Spain, 17007Hospital Universitario De Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria , Spain, 35012Local Institution - 695 | Madrid , Spain, 28040University Hospital Puerta de Hierro Majadajonda | Majadahonda, Madrid , Spain, 28222University Hospital Marques de Valdecilla (HUMV) | Santander , Spain, 39008Local Institution - 697 | Valencia , Spain, 46010Local Institution - 625 | Stockholm , Sweden, 112 81Local Institution - 460 | Kaohsiung City , Taiwan, 82445Local Institution - 463 | Kaohsiung, San Ming Dist. , Taiwan, 807Local Institution - 461 | Niao-Sung Hsiang Kaohsiung County , Taiwan, 83301Local Institution - 459 | Tainan, Taiana , Taiwan, 704Local Institution - 462 | Taoyuan City , Taiwan, 33305Local Institution - 464 | Tapei, Beitou Dist. , Taiwan, 11217Local Institution - 465 | Tapei , Taiwan, 10002Local Institution - 357 | Ankara , Turkey (Türkiye), 01660Local Institution - 365 | Elâzığ , Turkey (Türkiye), 23119Local Institution - 358 | Istanbul , Turkey (Türkiye), 34098Local Institution - 361 | Istanbul , Turkey (Türkiye), 34668Local Institution - 353 | Kadiköy/Istanbul , Turkey (Türkiye), 41380Local Institution - 922 | Chernivtsi , Ukraine, 58001Local Institution - 929 | Ivano-Frankivsk , Ukraine, 76008Local Institution - 965 | Kharkiv , Ukraine, 61037Local Institution - 920 | Khmelnytskyi , Ukraine, 29000Local Institution - 933 | Kropyvnytskyi , Ukraine, 25006Local Institution - 923 | Kyiv , Ukraine, 01601Local Institution - 563 | Kyiv , Ukraine, 02002Local Institution - 564 | Kyiv , Ukraine, 03037Local Institution - 977 | Kyiv , Ukraine, 04107Local Institution - 590 | Lutsk , Ukraine, 43005Local Institution - 974 | Lviv , Ukraine, 79010Local Institution - 902 | Odesa , Ukraine, 65025Local Institution - 932 | Vinnytsia , Ukraine, 21009Local Institution - 924 | Vinnytsia , Ukraine, 21018Local Institution - 587 | Zaporizhia , Ukraine, 69063Local Institution - 925 | Zaporizhzhya , Ukraine, 69600
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full Text)
Documents provided by Celgene: Study Protocol and Statistical Analysis Plan  June 13, 2021