Clinical trial NCT03517722: A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-05-07
Enrollment: 516
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
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 efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.

Detailed description: This study evaluates the efficacy, safety, and tolerability of ustekinumab in participants with active SLE according to Systemic Lupus International Collaborating Clinics (SLICC) criteria Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than (\>=) 6, despite receiving one or more standard-of-care treatments (example, immunomodulators, antimalarial drugs, and/or glucocorticoids). The total duration of the study is up to 182 weeks, consisting of 3 study periods: a screening period (approximately 6 weeks), a double blind period (52 weeks), and an extension period (124 weeks). Other study evaluations will include pharmacokinetics, immunogenicity, biomarkers and pharmacogenomic evaluations. The safety of the participants enrolled in the study will be monitored on an ongoing basis throughout the study.

Eligibility criteria: Inclusion Criteria:

* Be male or female
* Has a documented medical history (that is, met at least 1 of the two criteria below) that participant met the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior to first dose of study agent:

  1. Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic;
  2. Has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of the following autoantibodies: antinuclear antibodies (ANA) or anti-double-stranded deoxyribonucleic acid (anti-dsDNA)
* Has a positive test in the medical history and confirmed at screening for at least 1 of the following autoantibodies: antinuclear antibodies, anti-double-stranded deoxyribonucleic acid, and/or anti-Smith
* Has greater than or equal to (\>=) 1 British Isles Lupus Assessment Group (BILAG) A and/or \>= 2 BILAG B scores observed during screening
* Has a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score \>=4 (excluding diffuse non-inflammatory alopecia) or \>= 4 joints with pain and signs of inflammation at screening, Week 0, or both
* Has a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score \>=6 at screening. Must also have SLEDAI-2K \>= 4 for clinical features (excluding headache and laboratory abnormalities) at Week 0
* Cannot be pregnant, nursing, intending to become pregnant, or unwilling to follow contraception or egg/sperm donation guidelines
* Must be receiving stable doses of \>=1 protocol-permitted standard of care SLE treatment: oral glucocorticoids, anti-malarials, immunomodulators (methotrexate, azathioprine, 6-mercaptopurine, mycophenolate mofetil, mycophenolic acid)

Exclusion Criteria:

* Has any unstable or progressive SLE manifestation (example: central nervous system lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in therapy beyond permitted background medications. Participants requiring renal hemodialysis or peritoneal dialysis are also excluded
* Has other co-existent inflammatory diseases (example: rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn's disease)
* Has a urinary protein to creatinine ratio of greater than (\>)4 gram per gram (g/g) per day
* Has an acute or chronic infectious illness (example: human immunodeficiency virus, hepatitis B or C virus, tuberculosis, opportunistic infections)
* Has a history of cancer or lymphoproliferative disease within the last 5 years except for treated and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma
* Has any condition requiring multiple courses of systemic glucocorticoids (example: uncontrolled asthma, chronic obstructive pulmonary disease)
* Has a history of major surgery within the last month
* Has received live virus or bacterial vaccines within 16 weeks prior to first dose of study agent or Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
* Has previously received ustekinumab
* Has received cyclophosphamide orally within 90 days or intravenously within 180 days of screening
* Has received a single B-cell targeted therapy (e.g. belimumab) within 3 months, \>1 previous B-cell targeted therapy within 6 months, or B-cell depleting therapy (example: rituximab) within 12 months of first dose of study agent
* Has received protocol-prohibited oral or biologic immunomodulatory therapy in the last 3 months or less than (\<)5 half-lives (whichever is longer) prior to first dose of study agent
* Has received adrenocorticotropic hormone (ACTH) within 1 month prior to first dose of study agent
* Has received epidural, intravenous, intramuscular, intraarticular, intrabursal, intralesional glucocorticoids within 6 weeks of first dose of study agent
* Locally-delivered therapies except for ophthalmic use of cyclosporine A or topical use of nonsteroidal anti inflammatory drugs (NSAIDs), analgesics, or high-potency glucocorticoids (World Health Organization criteria) are prohibited

Primary outcomes:
measure: Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Time to First Flare
timeFrame: Up to Week 52
measure: Percentage of Participants With an SRI-4 Composite Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52
timeFrame: Week 52
measure: Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52
timeFrame: Up to Week 52
measure: Percentage of Participants With at Least a 50% Improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 52
timeFrame: Week 52
measure: Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40, Sustained That Change Through Week 52, and Achieved an SRI-4 Composite Response at Week 52
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Vestavia Hills
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Glendale
country: United States
facility: Lugene Eye Institute
state: California
city: Hemet
country: United States
facility: C.V. Mehta, MD Medical Corp.
state: California
city: La Jolla
country: United States
facility: University of California at San Diego
state: California
city: Lakewood
country: United States
facility: Advanced Medical Research - Lakewood
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health Care
state: California
city: Los Alamitos
country: United States
facility: Valerius Medical Group & Research Center
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Los Angeles
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group
state: California
city: Thousand Oaks
country: United States
facility: Westlake Medical Research Clinical Trials
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: New Haven
country: United States
facility: UPMC Lupus Center of Excellence
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, PA
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology And Immunology Specialists
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Healthcare - Piedmont Hospital
state: Georgia
city: Decatur
country: United States
facility: DeKalb Medical Specialty Center
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic - Bowling Green
state: Kentucky
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic
state: Louisiana
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Lansing
country: United States
facility: June DO, PC.
state: Michigan
city: Eagan
country: United States
facility: St Paul Rheumatology PA
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Las Vegas
country: United States
facility: Oklahoma Medical Research Foundation
state: Nevada
city: Las Vegas
country: United States
facility: Innovative Health Research
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Center for Rheumatology
state: New Mexico
city: Lake Success
country: United States
facility: Biomedical Research Alliance Of New York
state: New York
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: NYU Center for Musculoskeletal Care
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: OK Center for Arthritis Therapy & Research, Inc.
state: Oklahoma
city: Philadelphia
country: United States
facility: Lewis Katz School of Medicine, Temple University
state: Pennsylvania
city: Wexford
country: United States
facility: Allegheny Rheumatology/Allegheny Singer Research Institute
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Arthritis Center
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Dr. Ramesh Gupta
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research
state: Texas
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Dallas
country: United States
facility: Arthritis Centers of Texas
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: UT Health Science Center at San Antonio
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Fundacion CENIT para la Investigacion en Neurociencias
city: Buenos Aires
country: Argentina
facility: Instituto Centenario
city: Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar
city: Ciudad De La Plata
country: Argentina
facility: Framingham Centro Medico
city: Cordoba
country: Argentina
facility: Hospital Italiano de Cordoba
city: Corrientes
country: Argentina
facility: Hospital Escuela 'Gral. Jose F. de San Martin'
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
city: San Miguel de Tucumán
country: Argentina
facility: Centro Medico Privado de Reumatologia
city: Plovdiv
country: Bulgaria
facility: MHAT Trimantium
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center (DCC) Aleksandrovska
city: Sofia
country: Bulgaria
facility: UMHAT St. Ivan Rilski
city: Sofia
country: Bulgaria
facility: Medical Centre Synexus
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Quebec
country: Canada
facility: CHU de Québec
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Med U
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huangzhong Univ
city: Xi'an
country: China
facility: The 1st affiliated Hospital of Xi'an Traffic University
city: Bogotá
country: Colombia
facility: Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
city: Bucaramanga
country: Colombia
facility: IPS Medicity SAS
city: Bucaramanga
country: Colombia
facility: Servimed S A S
city: Chia
country: Colombia
facility: Preventive Care Ltda
city: Medellin
country: Colombia
facility: Clinica Universitaria Bolivariana
city: Montería
country: Colombia
facility: Funcentra
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin (CCM)
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Leipzig
country: Germany
facility: Rheumatology Unit
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Budapest
country: Hungary
facility: Szt, Istvan and Szt. Laszlo
city: Gyula
country: Hungary
facility: Bekes Megyei Pandy Kalman Korhaz
city: Zalaegerszeg
country: Hungary
facility: Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: National Hospital Organization Chiba East Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
city: Hukuoka
country: Japan
facility: Hospital of the University of Occupational and Enviromental Health
city: Kawachi Nagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
city: Kitakyushu
country: Japan
facility: Kawasaki Rheumatism and Internal Medicine Clinic
city: Meguro-ku
country: Japan
facility: Toho University Medical Center, Ohashi Hospital
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Sapporo
country: Japan
facility: Sapporo City General Hospital
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
city: Sendai shi
country: Japan
facility: Tohoku University Hospital
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
city: Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: JeonJu
country: Korea, Republic of
facility: Chonbuk National Univ Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Kaunas
country: Lithuania
facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Vilnius
country: Lithuania
facility: Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
city: Bytom
country: Poland
facility: Nzoz Bif Med
city: Lodz
country: Poland
facility: Centrum Medyczne AMED oddzial w Lodzi
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Sonoswiec
country: Poland
facility: Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska
city: Tychy
country: Poland
facility: Centrum Medyczne Pratia Tychy
city: Warszawa
country: Poland
facility: Centrum Medyczne Pratia Warszawa
city: Warszawa
country: Poland
facility: Reumatika-Centrum Reumatologii, NZOZ
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
city: Lisboa
country: Portugal
facility: Instituto Portugues de Reumatologia
city: Lisboa
country: Portugal
facility: Uls Sao Jose - Hosp. Curry Cabral
city: Lisboa
country: Portugal
facility: Hosp. Da Luz Lisboa
city: Ponte de Lima
country: Portugal
facility: ULSAM, EPE - Hospital Conde de Bertiandos
city: Vila Nova de Gaia
country: Portugal
facility: C.H. de Vila Nova de Gaia/Espinho
city: Kemerovo
country: Russian Federation
facility: Regional Clinical Hospital for War Veterans
city: Kemerovo
country: Russian Federation
facility: LLL Medical Center Revma-Med
city: Omsk
country: Russian Federation
facility: Clinical Diagnostic Center 'Ultramed'
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad region clinical hospital
city: St. Petersburg
country: Russian Federation
facility: City Clinical Hospital #31
city: St.-Petersburg
country: Russian Federation
facility: Northen-Western State Medical University n.a. I.I. Mechnikov
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital
city: Yaroslavl
country: Russian Federation
facility: Clinical Emergency Hospital n.a. N.V. Solovyev
city: Belgrade
country: Serbia
facility: Institute of Rheumatology Belgrade
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Niska Banja
country: Serbia
facility: Institute for Treatment and Rehabilitation Niska Banja
city: Vojvodina
country: Serbia
facility: Clinical Center of Vojvodina
city: Cape Town
country: South Africa
facility: Panorama Medical Centre
city: George
country: South Africa
facility: Excellentis Clinical trial Consultants
city: Pretoria
country: South Africa
facility: Clinical Research Unit, University of Pretoria
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Bilbao
country: Spain
facility: Hosp. Univ. de Basurto
city: Cordoba
country: Spain
facility: Hosp Reina Sofia
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Málaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: San Sebastián de los Reyes
country: Spain
facility: Hosp. Univ. Infanta Sofia
city: Sevilla
country: Spain
facility: Hosp. Infanta Luisa
city: Vigo -Pontevedra
country: Spain
facility: Hosp. Do Meixoeiro
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Kwei-san Hsiang
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital and Medical College
city: Bangkok
country: Thailand
facility: Rajavhiti Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Hat Yai
country: Thailand
facility: Songklanagarind hospital
city: Muang
country: Thailand
facility: Chiang Mai University
city: Kharkiv
country: Ukraine
facility: Mechnikov Inst, Miska bagatoprofilna likarnia #18
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #3
city: Kyiv
country: Ukraine
facility: Kyivska oblasna klinichna likarnia
city: Odesa
country: Ukraine
facility: Odeska oblasna klinichna likarnia
city: Odessa
country: Ukraine
facility: Multidisciplinary Medical Center of Odessa National Medical University
city: Vinnytsia
country: Ukraine
facility: MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
city: Vinnytsia
country: Ukraine
facility: Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: van Vollenhoven RF, Kalunian KC, Dorner T, Hahn BH, Tanaka Y, Gordon RM, Shu C, Fei K, Gao S, Seridi L, Gallagher P, Lo KH, Berry P, Zuraw QC. Phase 3, multicentre, randomised, placebo-controlled study evaluating the efficacy and safety of ustekinumab in patients with systemic lupus erythematosus. Ann Rheum Dis. 2022 Oct 12;81(11):1556-1563. doi: 10.1136/ard-2022-222858.
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.