Clinical trial NCT05620407: A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Autoimmune Diseases
Immune System Diseases
Connective Tissue Diseases
Immune-mediated Diseases
Active Systemic Lupus Erythematosus
Lupus
SLE
Deucravacitinib
Tyk2
POETYK
POETYK SLE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-11-17
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.


Eligibility criteria: Inclusion Criteria

* Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.
* Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
* One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.
* Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.
* Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.
* At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.
* Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.

Exclusion Criteria

* Diagnosis of drug-induced SLE rather than idiopathic SLE.
* Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.
* Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.
* Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
* History of congenital or acquired immunodeficiency.
* Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).
* Taking more than 1 immunosuppressant at screening.
* In Japan only: Participants with positive result of β - D-glucan assay.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
timeFrame: At week 52
Secondary outcomes:
measure: Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
timeFrame: At week 52
measure: Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
timeFrame: At week 52
measure: Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score
timeFrame: At week 52
measure: Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
timeFrame: At week 52
measure: Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits
timeFrame: Up to 52 weeks
measure: Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
timeFrame: At week 52
measure: Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
timeFrame: At week 52
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 156 weeks
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 156 weeks
measure: Number of participants with AEs leading to discontinuation of treatment
timeFrame: Up to 156 weeks
measure: Number of participants with AEs leading to study discontinuation
timeFrame: Up to 156 weeks
measure: Number of participants with target adverse events of special interest (AESIs)
timeFrame: Up to 156 weeks
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 156 weeks
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 156 weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 156 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD - Altman Clinical and Translational Research Institute (ACTRI)
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group, Inc
state: California
city: Santa Monica
country: United States
facility: Providence Saint John's Medical Foundation
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater)
state: Florida
city: Jacksonville
country: United States
facility: UF Health Deerwood Park
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials
state: Florida
city: Pompano Beach
country: United States
facility: Nuline Clinical Trial Center
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine- Grady Campus
state: Georgia
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology
state: Georgia
city: Orland Park
country: United States
facility: Greater Chicago Specialty Physicians - Orland Park
state: Illinois
city: Skokie
country: United States
facility: Local Institution - 0041
state: Illinois
city: New Orleans
country: United States
facility: Local Institution - 0231
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Grand Blanc
country: United States
facility: AA Medical Research Center-Grand Blanc
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota
state: Minnesota
city: Las Vegas
country: United States
facility: Local Institution - 0200
state: Nevada
city: Las Vegas
country: United States
facility: Local Institution - 0216
state: Nevada
city: Paramus
country: United States
facility: The Valley Hospital, Inc.
state: New Jersey
city: Brooklyn
country: United States
facility: Joseph S. and Diane H. Steinberg Ambulatory Care Center
state: New York
city: Great Neck
country: United States
facility: Irving Goldman Family Care Center
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0178
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Allegheny Health
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Florence
country: United States
facility: Hope Health
state: South Carolina
city: Florence
country: United States
facility: Local Institution - 0228
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Colleyville
country: United States
facility: Local Institution - 0001
state: Texas
city: El Paso
country: United States
facility: Texas Arthritis Center
state: Texas
city: Katy
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Ciudad de Buenos Aires
country: Argentina
facility: Sanatorio Guemes
state: Buenos Aires
city: Florencio Varela
country: Argentina
facility: Hospital El Cruce
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Buenos Aires
city: Pergamino
country: Argentina
facility: Centro de Investigacion Pergamino S.A.
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: San Miguel
country: Argentina
facility: Centro Dermatológico Schejtman
state: Buenos Aires
city: Quilmes
country: Argentina
facility: CER medical Institute
state: Ciudad Autónoma De Buenos Aires
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: San Miguel de Tucumán
country: Argentina
facility: Centro Integral de Reumatologia
state: Tucumán
city: Río Cuarto
country: Argentina
facility: Local Institution - 0141
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Paramatta
country: Australia
facility: BJC Health
state: New South Wales
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
state: Queensland
city: Ivanhoe
country: Australia
facility: Austin Health - Repatriation Hospital
state: Victoria
city: Victoria Park
country: Australia
facility: RK Will Pty Ltd
state: Western Australia
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Recife
country: Brazil
facility: Local Institution - 0232
state: Pernambuco
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Velho
country: Brazil
facility: Local Institution - 0230
state: Rondônia
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: São Paulo
city: Santo André
country: Brazil
facility: Local Institution - 0095
state: São Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clinicos
state: São Paulo
city: Curitiba
country: Brazil
facility: Local Institution - 0033
city: Rio de Janeiro
country: Brazil
facility: Hospital São Lucas de Copacabana
city: São Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: São Paulo
country: Brazil
facility: Hospital 9 De Julho
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Centre (DCC) - Foкus 5
state: Sofia (stolitsa)
city: Plovdiv
country: Bulgaria
facility: University Hospital Kaspela Clinic of Rheumatology
city: Ruse
country: Bulgaria
facility: Diagnostic Consultative Centre 1 Ruse
city: Sofia
country: Bulgaria
facility: Local Institution - 0214
city: La Serena
country: Chile
facility: IC La Serena Research
state: Coquimbo
city: Valdivia
country: Chile
facility: Local Institution - 0099
state: Los Ríos
city: Santiago
country: Chile
facility: Estudios Clinicos CTR
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Biomedica Research Group
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Estudios Clinicos Limitada
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0044
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0098
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Clínica Ensenada
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0153
city: Ostrava
country: Czechia
facility: INREA s.r.o.
state: Ostrava Město
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Athens
country: Greece
facility: General Hospital of Athens Hippokratio
state: Attikí (Region)
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
state: Attikí
city: Larissa
country: Greece
facility: University General Hospital of Larissa
state: Thessalía
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ
state: Baranya
city: Gyula
country: Hungary
facility: Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház
state: Békés
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
state: Csongrád
city: Veszprem
country: Hungary
facility: Vital Medical Center
state: Veszprém City
city: New Delhi
country: India
facility: Local Institution - 0197
state: Delhi
city: Ahmedabad
country: India
facility: Local Institution - 0209
state: Gujarat
city: Ahmedabad
country: India
facility: Local Institution - 0233
state: Gujarat
city: Hubli
country: India
facility: Sushruta Multispeciality Hospital & Research Centre
state: Karnataka
city: Mysore
country: India
facility: JSS Hospital
state: Karnataka
city: Nagpur
country: India
facility: Local Institution - 0229
state: Maharashtra
city: Vellore
country: India
facility: Christian Medical College Vellore
state: Tamil Nadu
city: Vellore
country: India
facility: Local Institution - 0204
state: Tamil Nadu
city: Secundarabad
country: India
facility: Krishna Institute of Medical Science
state: Telangana
city: Nagoya
country: Japan
facility: Koujunkai Daido Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution - 0156
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University
state: Aichi
city: Eiheiji-cho,Yoshida-gun
country: Japan
facility: Local Institution - 0086
state: Fukui
city: Kitakyushu
country: Japan
facility: University of Occupational and Enviromental Health
state: Fukuoka
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kita
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Shimotsuga
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo
city: Toyoma
country: Japan
facility: Toyama University Hospital
state: Toyama
city: Chiba
country: Japan
facility: National Hospital Organization Chibahigashi National Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Keio university hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Torreón
country: Mexico
facility: CIMAB SA de CV
state: Coahuila
city: Cdmx
country: Mexico
facility: Local Institution - 0015
state: Distrito Federal
city: Mexico city
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Mexico City
country: Mexico
facility: CAIMED Investigacion en Salud
state: Distrito Federal
city: Leon
country: Mexico
facility: Centro de Investigacion Farmacologica del Bajio SC
state: Guanajuato
city: Guadajalara
country: Mexico
facility: Boca Clinical Trials Mexico S.C.
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V.
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Local Institution - 0010
state: Morelos
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo LEON
city: Chihuahua
country: Mexico
facility: Local Institution - 0096
city: Chihuahua
country: Mexico
facility: IMACEN S.A de C.V.
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Lima
country: Peru
facility: Local Institution - 0100
city: Lima
country: Peru
facility: Instituto Peruano del Hueso y la Articulación
city: Lima
country: Peru
facility: ACQ Medic SAC - Centro de Investigación Clinica Inmunoreumatología
city: Lima
country: Peru
facility: Local Institution - 0093
city: Lima
country: Peru
facility: Clinica San Juan Bautista
city: Lima
country: Peru
facility: Clinica Medica Cayetano Heredia
city: Wroclaw
country: Poland
facility: Local Institution - 0218
state: Dolnośląskie
city: Lublin
country: Poland
facility: Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda
state: Lubelskie
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park
state: Mazowieckie
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
state: Mazowieckie
city: Warszawa
country: Poland
facility: Futuremeds Targowek
state: Mazowieckie
city: Kraków
country: Poland
facility: Pratia MCM Krakow
state: Małopolskie
city: Elbląg
country: Poland
facility: Local Institution - 0016
state: Warmińsko-mazurskie
city: Poznan
country: Poland
facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Centrum Wsparcia Badań Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Wroclaw
country: Poland
facility: Local Institution - 0031
city: Lodz
country: Poland
facility: SOMED CR
state: Łódzkie
city: Chorzów
country: Poland
facility: M2M Med
state: Śląskie
city: Lisbon
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
state: Lisboa
city: Bila Nova De Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
city: Lisbon
country: Portugal
facility: Instituto Portugues de Reumatologia
city: Lisbon
country: Portugal
facility: Hospital Professor Doutor Fernando Fonseca
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Local Institution - 0127
city: Mérida
country: Spain
facility: Hospital de Mérida
state: Badajoz
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Madrid
city: Bilbo
country: Spain
facility: Osi Bilbao-Basurto
state: País Vasco
city: Vitoria-Gasteiz
country: Spain
facility: Local Institution - 0055
state: País Vasco
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taichung
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Local Institution - 0207
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Krung Thep Maha Nakhon
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Hastanesi
city: Gaziantep
country: Turkey
facility: NCR International Hospital
city: Istanbul
country: Turkey
facility: Local Institution - 0170
city: London
country: United Kingdom
facility: Royal Free Hospital
state: England
city: London
country: United Kingdom
facility: King's College Hospital
state: Greater London
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
state: London, City Of
city: Central Middlesbrough
country: United Kingdom
facility: Local Institution - 0168
state: Middlesbrough
city: Bradford
country: United Kingdom
facility: Local Institution - 0092
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals - Nuffield Orthopaedic Centre
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: