Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery (AXIOMATIC-TKR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891524
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death) during the treatment period.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Drug: JNJ-70033093 25 mg Drug: JNJ-70033093 50 mg Drug: JNJ-70033093 100 mg Drug: JNJ-70033093 200 mg Drug: Placebo Drug: Enoxaparin 40 mg Phase 2

Detailed Description:
JNJ-70033093 is an oral anticoagulant for prevention and treatment of thromboembolic events (for example, VTE) that binds and inhibits activated form of human coagulation Factor XI (FXIa) with high affinity and selectivity. The study will consist of 3 phases: up to 30-day screening phase before total knee replacement (TKR) surgery, 10 to14 day postoperative dosing phase, and 4-week follow-up phase. The hypothesis of this study is JNJ-70033093 reduces risk of total VTE during treatment period. The total duration of participation following randomization will be approximately 6 weeks. Efficacy evaluations include unilateral venography assessment of operated leg and assessments of symptomatic DVT, PE, or death. Safety evaluation includes adverse events, clinical laboratory tests, and physical examinations. The safety and efficacy will be monitored throughout the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Treatment arms and study drug dose regimens will be blinded.
Primary Purpose: Prevention
Official Title: A Randomized, Open-Label, Study Drug-Dose Blind, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-70033093 (BMS-986177), an Oral Factor XIa Inhibitor, Versus Subcutaneous Enoxaparin in Subjects Undergoing Elective Total Knee Replacement Surgery
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : March 23, 2021
Estimated Study Completion Date : March 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Group A: JNJ-70033093 25 mg + Placebo BID
Participants will receive JNJ-70033093 25 milligram (mg) (1*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
Drug: JNJ-70033093 25 mg
Participants will receive JNJ-70033093 25 mg (1*25 mg capsule) BID (in Group A) or once daily (in Group E), orally for 10 to 14 postoperative days.
Other Name: BMS-986177

Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.

Experimental: Group B: JNJ-70033093 50 mg BID
Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
Drug: JNJ-70033093 50 mg
Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
Other Name: BMS-986177

Experimental: Group C: JNJ-70033093 100 mg + Placebo BID
Participants will receive JNJ-70033093 100 mg (1*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
Drug: JNJ-70033093 100 mg
Participants will receive JNJ-70033093 100 mg (1*100 mg capsule) BID, orally for 10 to 14 postoperative days.
Other Name: BMS-986177

Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.

Experimental: Group D: JNJ-70033093 200 mg BID
Participants will receive JNJ-70033093 200 mg (2*100 mg capsules) BID orally for 10 to 14 postoperative days.
Drug: JNJ-70033093 200 mg
Participants will receive JNJ-70033093 200 mg (2*100 mg capsules) BID (in Group D) or once daily (in Group F), orally for 10 to 14 postoperative days.
Other Name: BMS-986177

Experimental: Group E: JNJ-70033093 25 mg Once Daily + Placebo
Participants will receive JNJ-70033093 25 mg (1*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
Drug: JNJ-70033093 25 mg
Participants will receive JNJ-70033093 25 mg (1*25 mg capsule) BID (in Group A) or once daily (in Group E), orally for 10 to 14 postoperative days.
Other Name: BMS-986177

Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.

Experimental: Group F: JNJ-70033093 200 mg Once Daily + Placebo
Participants will receive JNJ-70033093 200 mg (2*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
Drug: JNJ-70033093 200 mg
Participants will receive JNJ-70033093 200 mg (2*100 mg capsules) BID (in Group D) or once daily (in Group F), orally for 10 to 14 postoperative days.
Other Name: BMS-986177

Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.

Experimental: Group G: JNJ-70033093 50 mg once daily + Placebo
Participants will receive JNJ-70033093 50 mg (2*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
Drug: JNJ-70033093 50 mg
Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
Other Name: BMS-986177

Drug: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.

Active Comparator: Group I: Enoxaparin 40 mg Once Daily
Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
Drug: Enoxaparin 40 mg
Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.




Primary Outcome Measures :
  1. Number of Participants with Total Venous Thromboembolism (VTE) [ Time Frame: Up to 14 days ]
    Total VTE is defined as the composite of proximal and/or distal Deep Vein Thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death.


Secondary Outcome Measures :
  1. Number of Participants with any Bleeding Event [ Time Frame: Up to 14 days ]
    Any bleeding event is defined as the composite of major, clinically relevant nonmajor, and/or minimal bleeding events.

  2. Number of Participants with Total VTE [ Time Frame: Up to Week 6 ]
    Total VTE is defined as the composite of proximal and/or distal Deep Vein Thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death.

  3. Number of Participants with any Bleeding Event [ Time Frame: Up to Week 6 ]
    Any bleeding event is defined as the composite of major, clinically relevant nonmajor, and/or minimal bleeding events.

  4. Number of Participants with Composite of Major and Clinically Relevant Nonmajor Bleeding Events [ Time Frame: Up to Week 6 ]
    Bleeding events composite of major and clinically relevant nonmajor events will be assessed through Week 6.

  5. Number of Participants with Major Bleeding Events [ Time Frame: Up to Week 6 ]
    Major bleeding is defined as: Fatal bleeding; bleeding that is symptomatic and occurs in a critical area or organ and/or; extrasurgical site bleeding causing a fall in hemoglobin level of 20 gram per liter (g/L) (1.24 millimole per liter [mmol/L]) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to the bleeding, and/or; surgical site bleeding that requires a second intervention open, arthroscopic, endovascular, or a hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.

  6. Number of Participants with Clinically Relevant Nonmajor Bleeding Events [ Time Frame: Up to Week 6 ]
    Clinically relevant nonmajor bleeding is defined as acute clinically overt bleeding which does not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least 1 of the following criteria: Epistaxis (nose bleed), Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.

  7. Number of Participants with Minimal Bleeding Events [ Time Frame: Up to Week 6 ]
    Any overt bleeding not meeting major or clinically relevant nonmajor criteria will be assessed as minimal bleeding.

  8. Number of Participants with Major VTE [ Time Frame: Up to 14 days and up to Week 6 ]
    Major VTE is a composite of asymptomatic or symptomatic proximal DVT, PE, or any death.

  9. Number of Participants with Proximal and/or Distal Deep Vein Thrombosis (DVT) [ Time Frame: Up to 14 days and up to Week 6 ]
    Number of Participants with Proximal and/or Distal Deep Vein Thrombosis (DVT) will be assessed. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.

  10. Number of Participants with Nonfatal Pulmonary Embolism (PE) [ Time Frame: Up to 14 days and up to Week 6 ]
    Number of Participants with Nonfatal Pulmonary Embolism (PE) will be assessed. For all participants with symptoms of PE, spiral computed tomography (CT), pulmonary angiography, or perfusion/ventilation lung scintigraphy combined with chest radiography will be performed.

  11. Number of Participants with Deaths [ Time Frame: Up to 14 days and up to Week 6 ]
    Number of participants with deaths will be reported.

  12. Apparent Clearance (CL/F) of JNJ-70033093 [ Time Frame: Day 1: 2, 4, and 12 hours postdose; Day 2; Day 4: 0, 2, 4, and 12 hours postdose; Day 7; and Day 10 to Day 14 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.

  13. Apparent Volume of Distribution (V/F) of JNJ-70033093 [ Time Frame: Day 1: 2, 4, and 12 hours postdose; Day 2; Day 4: 0, 2, 4, and 12 hours postdose; Day 7; and Day 10 to Day 14 ]
    V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.

  14. Impact of Selected Demographics or Laboratory Values (Example [e.g.] sex, age, Weight) on Apparent Clearance (CL/F) [ Time Frame: Day 1: 2, 4, and 12 hours postdose; Day 2; Day 4: 0, 2, 4, and 12 hours postdose; Day 7; and Day 10 to Day 14 ]
    Impact of selected demographics or laboratory values (e.g. sex, age, weight) on Apparent Clearance (CL/F) will be assessed.

  15. Impact of Selected Demographics or Laboratory Values (e.g. sex, age, Weight) on Apparent Volume of Distribution (V/F) [ Time Frame: Day 1: 2, 4, and 12 hours postdose; Day 2; Day 4: 0, 2, 4, and 12 hours postdose; Day 7; and Day 10 to Day 14 ]
    Impact of selected demographics or laboratory values (e.g. sex, age, weight) on V/F will be assessed.

  16. Relationship between JNJ-70033093 Dose Levels with Total VTE [ Time Frame: Up to 14 days ]
    Relationship between JNJ-70033093 dose levels with total VTE will be determined using a multiple comparison procedures and modeling (MCP-Mod) approach.

  17. Relationship Between JNJ-70033093 Dose Levels with Composite of Major or Clinically Relevant Nonmajor Bleeding Events [ Time Frame: Up to 14 days ]
    Relationship between JNJ-70033093 dose levels with composite of major or clinically relevant nonmajor bleeding events will be determined using a MCP-Mod approach.

  18. Relationship between JNJ-70033093 Dose Levels with Major Bleeding Events [ Time Frame: Up to 14 days ]
    Relationship between JNJ-70033093 dose levels with major bleeding events will be determined using a MCP-Mod approach.

  19. Relationship between JNJ-70033093 Dose Levels with Clinically Relevant Nonmajor Bleeding Events [ Time Frame: Up to 14 days ]
    Relationship between JNJ-70033093 dose levels with clinically relevant nonmajor bleeding events will be determined using a MCP-Mod approach.

  20. Relationship between JNJ-70033093 Dose Levels with Minimal Bleeding Events [ Time Frame: Up to 14 days ]
    Relationship between JNJ-70033093 dose levels with minimal bleeding events will be determined using a MCP-Mod approach.

  21. Relationship Between JNJ-70033093 Exposure with Total VTE [ Time Frame: Up to 14 days ]
    Relationship between JNJ-70033093 exposure with total VTE, determined using Exposure-Response analysis.

  22. Relationship Between JNJ-70033093 Exposure with Composite of Major or Clinically Relevant Nonmajor Bleeding Events [ Time Frame: Up to 14 days ]
    Relationship between JNJ-70033093 exposure with composite of major or clinically relevant nonmajor bleeding events, determined using Exposure-Response analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medically stable and appropriate for anticoagulant prophylaxis as determined by the investigator on the basis of physical examination, medical history, and vital signs performed as part of screening for elective total knee replacement (TKR) surgery
  • Medically stable and appropriate for anticoagulant prophylaxis on the basis of clinical laboratory tests performed as part of local standard-of-care as part of screening for elective TKR surgery
  • Has plans to undergo an elective primary unilateral TKR surgery
  • A woman must be- a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than [<]1 percent [%] per year when used consistently and correctly) and agrees to remain on a highly effective method for the duration of study drug with JNJ-70033093 plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle) for a total of 34 days after the completion of treatment, pregnancy testing (serum or urine) prior to the first dose of study drug
  • Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

  • History of any condition for which the use of low molecular-weight heparin (LMWH) is not recommended in the opinion of the investigator (for example, previous allergic reaction, creatinine clearance <30 milliliter per minute [mL/minute])
  • History of severe hepatic impairment
  • Planned bilateral revision or unicompartmental procedure
  • Unable to undergo venography (for example, due to contrast agent allergy, poor venous access, or impaired renal function that would increase the risk of contrast-induced nephropathy
  • Known previous pulmonary embolism (PE) or deep vein thrombosis (DVT) in either lower extremity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891524


Contacts
Layout table for location contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Central Research Associates, Inc. Not yet recruiting
Birmingham, Alabama, United States, 35205
United States, Arkansas
Bowen Hefley Orthopedics Not yet recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Harbor-UCLA Medical Center Not yet recruiting
Torrance, California, United States, 90509
United States, Colorado
Denver Metro Orthopedics, PC Recruiting
Englewood, Colorado, United States, 80113
United States, Florida
Florida Research Associates, LLC Not yet recruiting
DeLand, Florida, United States, 32720
Avanza research Not yet recruiting
Pensacola, Florida, United States, 32504
DMI Research Not yet recruiting
Pinellas Park, Florida, United States, 33782
Gulfcoast Research Institute Not yet recruiting
Sarasota, Florida, United States, 34232
University Orthopedic and Joint Replacement Center Recruiting
Tamarac, Florida, United States, 33321
United States, Idaho
St Lukes Regional Medical Not yet recruiting
Boise, Idaho, United States, 83712
United States, Texas
Sun City Orthopaedic and Hand Surgery Specialists Withdrawn
El Paso, Texas, United States, 79902
Memorial Hermann Memorial City Medical Center Recruiting
Houston, Texas, United States, 77024
Baylor Scott and White Health Withdrawn
Temple, Texas, United States, 76508
Argentina
Hospital Italiano de Buenos Aires Not yet recruiting
Caba, Argentina, C1199ABB
Clínica Adventista Belgrano Not yet recruiting
Caba, Argentina, C1430EGF
Hospital Britanico de Buenos Aires Not yet recruiting
Ciudad Autonoma de Buenos Aires, Argentina, C1280AEB
Hospital San Roque Not yet recruiting
Córdoba, Argentina, 5000
Clínica Chutro Not yet recruiting
Córdoba, Argentina, X5000EPU
Hospital Italiano La Plata Not yet recruiting
La Plata, Argentina, B1900AXI
Instituto de Investigaciones Clinicas Rosario Not yet recruiting
Rosario, Argentina, S2000BIF
Sanatorio Corporación Médica de General San Martín Not yet recruiting
San Martín, Argentina, B1650BNB
Belgium
ZNA Middelheim Recruiting
Antwerpen, Belgium, 2020
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3600
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
ZNA Jan Palfijn Recruiting
Merksem, Belgium, 2170
Brazil
Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina Not yet recruiting
Belo Horizonte, Brazil, 30130-100
Hospital Sao Francisco de Assis Not yet recruiting
Belo Horizonte, Brazil, 30360-290
Unicamp - Hospital de Clinicas Not yet recruiting
Campinas, Brazil, 13083-888
Hospital De Clínicas Da Universidade Federal Do Paraná Not yet recruiting
Curitiba, Brazil, 80060-900
Uniort.e - Hospital de ortopedia Not yet recruiting
Londrina, Brazil, 86050-000
Santa Casa de Misericordia de Porto Alegre Not yet recruiting
Porto Alegre, Brazil, 90020-090
Hospital e Maternidade Dr Christovão da Gama Not yet recruiting
Santo André, Brazil, 09030-010
Hospital Estadual Mario covas Not yet recruiting
Santo André, Brazil, 09190-615
Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo Not yet recruiting
São Paulo, Brazil, 05403-000
Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski Not yet recruiting
Pleven, Bulgaria, 5800
St. Pantaleimon Pleven UMHAT Not yet recruiting
Pleven, Bulgaria, 5802
Acibadem City Clinic Tokuda Hospital Recruiting
Sofa, Bulgaria, 1407
University Multiprofile Hospital Sofiamed Sofia Not yet recruiting
Sofia, Bulgaria, 1330
MHAT Tzaritza Joanna Recruiting
Sofia, Bulgaria, 1527
Medical Center - Medical Complex BEROE EOOD Recruiting
Stara Zagora, Bulgaria, 6000
Canada, Ontario
Hamilton Health Sciences Corporation Not yet recruiting
Hamilton, Ontario, Canada, L8V1C3
Lakeridge Health Not yet recruiting
Oshawa, Ontario, Canada, L1J 8R2
The Ottawa Hospital Research Institute Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Medical Investigative and Clinical Evaluation Inc Not yet recruiting
Windsor, Ontario, Canada, N8W 1E6
Greece
General Hospital of Attiki 'KAT' Not yet recruiting
Kifisia, Greece, 14561
General Hospital of Nea Ionia 'Konstantopoulio' Not yet recruiting
Nea Ionia, Greece, 14233
University General Hospital of Rio Patras Not yet recruiting
Patra, Greece, 26504
Papageorgiou General Hospital Not yet recruiting
Thessaloniki, Greece, 56403
Hungary
Semmelweis Egyetem Not yet recruiting
Budapest, Hungary, 1085
Debreceni Egyetem Recruiting
Debrecen, Hungary, 4032
Petz Aladar Megyei Oktato Korhaz Recruiting
Gyõr, Hungary, 9023
Somogy Megyei Kaposi Mor Oktato Korhaz Not yet recruiting
Kaposvar, Hungary, 7400
Bacs-kiskun Megyei Korhaz Recruiting
Kecskemét, Hungary, 6000
Szegedi Tudomanyegyetem Recruiting
Szeged, Hungary, 6725
Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz Recruiting
Szekesfehervar, Hungary, 8000
MAV Korhaz es Rendelointezet Recruiting
Szolnok, Hungary, 5000
Israel
Rambam Medical Center Not yet recruiting
Haifa, Israel, 31096
Carmel Medical Center Not yet recruiting
Haifa, Israel, 34362
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 44281
Kaplan Medical Center Not yet recruiting
Rehovot, Israel, 76100
Italy
Cliniche Humanitas Gavazzeni Recruiting
Bergamo, Italy, 24125
Azienda Ospedaliera Papa Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Istituto Ortopedico Rizzoli Not yet recruiting
Bologna, Italy, 40136
Azienda Ospedaliera Universitaria Careggi Withdrawn
Firenze, Italy, 50134
Policlinico S. Matteo Not yet recruiting
Pavia, Italy, 27100
Istituto Clinico Humanitas Recruiting
Rozzano, Italy, 20089
A.O.U. Città della Salute e della Scienza Not yet recruiting
Torino, Italy, 10126
Japan
Matsudo City General Hospital Not yet recruiting
Chiba, Japan, 270-2296
Funabashi Munitiple Medical Center Withdrawn
Chiba, Japan, 273-8588
Fukuoka Rehabilitation Hospital Withdrawn
Fukuoka-shi, Japan, 819-8551
Hakodate Goryokaku Hospital Not yet recruiting
Hakodate, Japan, 040-8611
Japanese Red Cross Hamamatsu Hospital Not yet recruiting
Hamamatsu, Japan, 434-8533
Hiroshima City Asa Citizens Hospital Withdrawn
Hiroshima, Japan, 731-0293
Itami City Hospital Not yet recruiting
Itami-shi, Japan, 664-8540
Yonemori Hospital Not yet recruiting
Kagoshima-shi, Japan, 890-0062
Japan Community Health care Organization Kyushu Hospital Not yet recruiting
Kitakyushu-shi,, Japan, 806-8501
Kyushu Rosai Hospital Withdrawn
Kitakyushu, Japan, 800-0296
Chugoku Rosai Hospital Withdrawn
Kure, Japan, 737-0193
Marunouchi Hospital Not yet recruiting
Matsumoto, Japan, 390-8601
Chubu Rosai Hospital Not yet recruiting
Nagoya, Japan, 455-8530
Okayama City General Medical Center Okayama City Hospital Withdrawn
Okayama, Japan, 700-8557
NHO Okayama Medical Center Not yet recruiting
Okayama, Japan, 701-1192
Osaka Saiseikai Nakatsu Hospital Withdrawn
Osaka-shi, Japan, 530-0012
Osaka Rosai Hospital Withdrawn
Osaka, Japan, 591-8025
Saitama City Hospital Not yet recruiting
Saitama-shi, Japan, 336-8522
Saitama Medical Center Not yet recruiting
Saitama, Japan, 330-0074
Nagano Prefectural Shinshu Medical Center Not yet recruiting
Suzaka, Japan, 386-8610
Juntendo University Hospital Not yet recruiting
Tokyo, Japan, 113-8431
Juntendo University Nerima Hospital Not yet recruiting
Tokyo, Japan, 177-8521
Yuuaikai Tomishiro Central Hospital Not yet recruiting
Tomigusuku, Japan, 901-0243
Saiseikai Wakayama Hospital Withdrawn
Wakayama, Japan, 640-8158
Shimonoseki City Hospital Withdrawn
Yamaguchi, Japan, 750-0041
Lithuania
Kaunas Clinical Hospital, Public Institution Not yet recruiting
Kaunas, Lithuania, LT44320
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Not yet recruiting
Kaunas, Lithuania, LT50161
Klaipeda University Hospital Not yet recruiting
Klaipeda, Lithuania, 92288
Vilnius University Santaros Klinikos Not yet recruiting
Vilnius, Lithuania, 08661
Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bielsku Podlaskim,Oddział Urazowo-Ortopedyczny Recruiting
Bielsk Podlaski, Poland, 17-100
Wojewodzki Szpital Zespolony w Kielcach, Klinika Chirurgii Ortopedyczno-Urazowej Not yet recruiting
Kielce, Poland, 25-001
Oddzial Ortopedii i Traumatologii Szpital Specjalistyczny im. L.Rydygiera Recruiting
Krakow, Poland, 31-826
CSK UM Klinika Ortopedii Recruiting
Lodz, Poland, 92-213
Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny Not yet recruiting
Lublin, Poland, 20-718
Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika Recruiting
Tarnow, Poland, 33-100
Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ Recruiting
Warszawa, Poland, 03-242
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Recruiting
Wroclaw, Poland, 50-556
Portugal
Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro Recruiting
Aveiro, Portugal, 3810-501
Hosp. de Cascais Not yet recruiting
Cascais, Portugal, 2755-009
Hospital da Luz Withdrawn
Lisboa, Portugal, 1500-650
H. Santo António - Centro Hospitalar do Porto Not yet recruiting
Porto, Portugal, 4099-001
Hospital CUF Porto Withdrawn
Porto, Portugal, 4100-180
CHS - Hosp. Orto. Sant'Iago do Outao Not yet recruiting
Setubal, Portugal, 2900-180
ULSAM, EPE - Hospital de Santa Luzia Recruiting
Viana do Castelo, Portugal, 4904-858
Russian Federation
Krasnoyask Regional Clinical Hospital Withdrawn
Krasnoyarsk, Russian Federation, 660022
Russian Ilizarov Scientific Center For Restorative Traumatology And Ortopaedics Not yet recruiting
Kurgan, Russian Federation, 640014
National Medical and Surgical Center named after N.I.Pirogov Not yet recruiting
Moscow, Russian Federation, 105203
Lyublino Railway Clinical Hospital n.a. N.A.Semashko of JSCo 'RZD' Not yet recruiting
Moscow, Russian Federation, 109386
Privolzhsky Regional Medical Center of Federal Medical and Biological Agency Not yet recruiting
Nizhniy Novgorod, Russian Federation, 603137
State Budgetary Healthcare Institution Orenburg Regional Clinical Hospital Not yet recruiting
Orenburg, Russian Federation, 460018
Russian Research Institute of Traumatology and Orthopaedics n.a.R.R.Vreden Not yet recruiting
Saint-Petersburg, Russian Federation, 195427
State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin Not yet recruiting
Samara, Russian Federation, 443095
Saratov Regional Clinical Hospital Not yet recruiting
Saratov, Russian Federation, 410053
Smolensk Federal Center of Traumatology, Orthopedics and Endoprothesis Replacement Not yet recruiting
Smolensk, Russian Federation, 214031
Sochi City Clinical Hospital #4 Not yet recruiting
Sochi, Russian Federation, 354057
Clinical Emergency Hospital n.a. N.V. Solovyev Not yet recruiting
Yaroslavl, Russian Federation, 150003
South Africa
Chris Hani Baragwanath Hospital Not yet recruiting
Johannesburg, South Africa, 2013
Charlotte Maxeke Johannesburg Academic Hospital Not yet recruiting
Johannesburg, South Africa, 2196
Steve Biko Academic Hospital Not yet recruiting
Pretoria, South Africa, 0001
Clinical Project Research SA Not yet recruiting
Worcester, South Africa, 6850
Spain
Hosp. Univ. Fundacion Alcorcon Recruiting
Alcorcón, Spain, 28922
Hosp. Univ. Germans Trias I Pujol Recruiting
Badalona, Spain, 08916
Hosp. Clinic I Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Hosp. Univ. de Bellvitge Recruiting
Barcelona, Spain, 08907
Hosp. Univ. Vall D´Hebron Recruiting
Barcelona, Spain, 8035
Complejo Hospitalario de Jaen Not yet recruiting
Jaen, Spain, 23007
Hosp. Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Hosp. Univ. 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Hosp. Univ. La Paz Not yet recruiting
Madrid, Spain, 28046
Corporacio Sanitari Parc Tauli Recruiting
Sabadell, Spain, 08208
Hosp. Clinico Univ. de Valencia Not yet recruiting
Valencia, Spain, 46010
Hosp. Univ. I Politecni La Fe Not yet recruiting
Valencia, Spain, 46026
Turkey
Adana City Hospital Not yet recruiting
Adana, Turkey, 01060
Dışkapı Yıldırım Beyazıd Training and Research Hospital Not yet recruiting
Ankara, Turkey, 06110
Yıldırım Beyazıt University Yenimahalle Training and Research Hospital Not yet recruiting
Ankara, Turkey, 06370
Antalya Training And Research Hospital Not yet recruiting
Antalya, Turkey, 07100
Bakirkoy Training and Research Hospital Not yet recruiting
Istanbul, Turkey, 34147
Şişli Etfal Research Training Hospital Not yet recruiting
Istanbul, Turkey, 34371
Izmir Tepecik Training and Research Hospital Not yet recruiting
Izmir, Turkey, 35180
Ukraine
Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council' Not yet recruiting
Cherkasy, Ukraine, 18009
Ivano-Frankivsk Regional Clinical Hospital Not yet recruiting
Ivano-Frankivsk, Ukraine, 76008
Institute of Spine and JointPathology named after Prof.Sytenko of NationalAcademy of MedicalSciences Not yet recruiting
Kharkiv, Ukraine, 61024
Municipal Institution of Health Care 'Kharkiv Regional Clinical Traumatology Hospital' Not yet recruiting
Kharkiv, Ukraine, 61176
Kyiv Regional Clinical Hospital Not yet recruiting
Kyiv, Ukraine, 04107
Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital' Not yet recruiting
Lviv-Vynnyky, Ukraine, 79495
State Institution Odesa Regional Clinical Hospital Not yet recruiting
Odesa, Ukraine, 65025
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov Not yet recruiting
Vinnytsia, Ukraine, 21018
Sponsors and Collaborators
Janssen Research & Development, LLC
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03891524     History of Changes
Other Study ID Numbers: CR108600
70033093THR2001 ( Other Identifier: Janssen Research & Development, LLC )
2018-004237-32 ( EudraCT Number )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes