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A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03517722
Recruitment Status : Active, not recruiting
First Posted : May 7, 2018
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: Placebo Drug: Ustekinumab (approximately 6 mg/kg) Drug: Ustekinumab 90 mg Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : January 22, 2021
Estimated Study Completion Date : December 14, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Ustekinumab

Arm Intervention/treatment
Experimental: Ustekinumab
Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.
Drug: Ustekinumab (approximately 6 mg/kg)
Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.
Other Name: Stelara

Drug: Ustekinumab 90 mg
Participants will receive 90 mg ustekinumab via SC route.
Other Name: Stelara

Experimental: Placebo
Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.
Drug: Placebo
Participants will receive placebo matching to ustekinumab IV or SC.

Drug: Ustekinumab 90 mg
Participants will receive 90 mg ustekinumab via SC route.
Other Name: Stelara




Primary Outcome Measures :
  1. Percentage of Participants Achieving an Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52 [ Time Frame: Week 52 ]
    SRI-4 is a composite of at least 4 point improvement in Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K), no worsening in British Isles Lupus Assessment Group (BILAG) and no worsening in Physician's Global Assessment of Disease Activity score (PGA).


Secondary Outcome Measures :
  1. Time to Flare [ Time Frame: Baseline to Week 52 ]
    Time to flare will be calculated with flare defined as either 1 or more new BILAG A or 2 or more new BILAG B domain scores relative to baseline.

  2. Percentage of Participants with an SRI-4 Composite Response at Week 24 [ Time Frame: Week 24 ]
    SRI-4 is a composite of at least 4 point improvement in SLEDAI-2K, no worsening in BILAG and no worsening in PGA.

  3. Percentage of Participants Achieving at Least a 50% Improvement in the Number of Joints with Pain and Signs of Inflammation at Week 52 [ Time Frame: Week 52 ]
    The percentage of participants achieving at least a 50 percent (%) improvement in the number of joints with pain and signs of inflammation at week 52 will be reported in participants with at least 4 affected joints at baseline.

  4. Percentage of Participants Receiving Glucocorticoids at Baseline who Achieve Reduction in Glucocorticoid Dose by Week 40 and Sustain That Reduction Through Week 52 [ Time Frame: Baseline to Week 52 ]
    Reduction of glucocorticoid dose is defined as a reduction in average daily oral glucocorticoid dose by at least 50% (relative to the baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to the baseline dose) so that the average daily dose is reduced to less than or equal to (<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose is defined as achieving an average daily oral glucocorticoid dose reduction (as described above) between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.

  5. Percentage of Participants Achieving at Least a 50% Improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 52 [ Time Frame: Week 52 ]
    Percentage of participants achieving at least 50% improvement in CLASI Activity Score at Week 52 will be reported in participants with a CLASI Activity Score of 4 or greater at baseline.

  6. Percentage of Participants Receiving Glucocorticoids at Baseline who Achieve Reduction in Glucocorticoid Dose by Week 40, Sustain That Reduction Through Week 52, and Achieve an SRI-4 Composite Response at Week 52 [ Time Frame: Baseline to Week 52 ]
    Percentage of participants receiving glucocorticoids at baseline who achieve reduction in glucocorticoidits dose (as described above) by Week 40, sustain that reduction through Week 52 (as described above), and achieve an SRI-4 composite response (as described above) at Week 52 will be reported.



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.


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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03517722


Locations
Hide Hide 204 study locations
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United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Achieve Clinical Research, LLC
Vestavia Hills, Alabama, United States, 35216
United States, California
Medvin Clinical Research
Covina, California, United States, 91722
Lugene Eye Institute
Glendale, California, United States, 91204
C.V. Mehta, MD Medical Corp.
Hemet, California, United States, 92543
University of California at San Diego
La Jolla, California, United States, 92093
Advanced Medical Research - Lakewood
Lakewood, California, United States, 90712
Loma Linda University
Loma Linda, California, United States, 92350
Loma Linda University Health Care
Loma Linda, California, United States, 92357
Valerius Medical Group & Research Center
Los Alamitos, California, United States, 90720
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
East Bay Rheumatology Medical Group
San Leandro, California, United States, 94578
Westlake Medical Research Clinical Trials
Thousand Oaks, California, United States, 91360
University Clinical Investigators, Inc
Tustin, California, United States, 92780
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States, 91786
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
United States, Connecticut
UPMC Lupus Center of Excellence
New Haven, Connecticut, United States, 06520
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
United States, Florida
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
Bay Area Arthritis and Osteoporosis
Brandon, Florida, United States, 33511
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States, 33309
University of Florida
Jacksonville, Florida, United States, 32207
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136-1002
New Horizon Research Center
Miami, Florida, United States, 33175
Rheumatology Associates of Central Florida, PA
Orlando, Florida, United States, 32806
Omega Research Consultants
Orlando, Florida, United States, 32810
Millennium Research
Ormond Beach, Florida, United States, 32174
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States, 33324
Clinical Research of West Florida
Tampa, Florida, United States, 33603
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
Piedmont Healthcare - Piedmont Hospital
Atlanta, Georgia, United States, 30309
DeKalb Medical Specialty Center
Decatur, Georgia, United States, 30033
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kentucky
Graves-Gilbert Clinic - Bowling Green
Bowling Green, Kentucky, United States, 42101
United States, Louisiana
Arthritis and Diabetes Clinic
Monroe, Louisiana, United States, 71203
United States, Maryland
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, Michigan
June DO, PC.
Lansing, Michigan, United States, 48910-8595
United States, Minnesota
St Paul Rheumatology PA
Eagan, Minnesota, United States, 55121
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Nevada
Oklahoma Medical Research Foundation
Las Vegas, Nevada, United States, 89102
Innovative Health Research
Las Vegas, Nevada, United States, 89128
United States, New Mexico
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, United States, 87102
United States, New York
Biomedical Research Alliance Of New York
Lake Success, New York, United States, 10075
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
NYU Center for Musculoskeletal Care
New York, New York, United States, 10016
Hospital for Special Surgery
New York, New York, United States, 10021
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Joint and Muscle Research Institute
Charlotte, North Carolina, United States, 28204
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States, 28210
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
OK Center for Arthritis Therapy & Research, Inc.
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Lewis Katz School of Medicine, Temple University
Philadelphia, Pennsylvania, United States, 19140
Allegheny Rheumatology/Allegheny Singer Research Institute
Wexford, Pennsylvania, United States, 15090
United States, South Carolina
Columbia Arthritis Center
Columbia, South Carolina, United States, 29204
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
Dr. Ramesh Gupta
Memphis, Tennessee, United States, 38119
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-3103
United States, Texas
Amarillo Center for Clinical Research
Amarillo, Texas, United States, 79124
Austin Regional Clinic
Austin, Texas, United States, 78731
Arthritis Centers of Texas
Dallas, Texas, United States, 75246
Sun Research Institute
San Antonio, Texas, United States, 78215
UT Health Science Center at San Antonio
San Antonio, Texas, United States, 78239
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
United States, West Virginia
Rheumatology & Pulmonary Clinic
Beckley, West Virginia, United States, 25801
Argentina
Instituto Centenario
Buenos Aires, Argentina, C1204AAP
Centro Privado de Medicina Familiar
Buenos Aires, Argentina, C1417EYG
Hospital Sirio Libanes
Buenos Aires, Argentina, C1419AHN
Framingham Centro Medico
Ciudad De La Plata, Argentina, B1902COS
Hospital Italiano de Cordoba
Cordoba, Argentina, X5004BAL
Hospital Escuela 'Gral. Jose F. de San Martin'
Corrientes, Argentina, 3400
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, Argentina, J5402DIL
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Argentina, T4000AXL
Bulgaria
MHAT Trimantium
Plovdiv, Bulgaria, 4000
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, Bulgaria, 1431
UMHAT 'St. Ivan Rilski'
Sofia, Bulgaria, 1612
Medical Centre Synexus
Sofia, Bulgaria, 1709
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1M4
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada
McMaster University
Hamilton, Canada, L8N 3Z5
CHU de Québec
Quebec, Canada, G1V-2L9
China
The First Affiliated Hospital of Baotou Medical University
Baotou, China, 014010
Peking Union Medical College Hospital
Beijing, China, 100730
West China Hospital, Sichuan University
Chengdu, China, 610041
Guangdong Provincial People's Hospital
Guangzhou, China, 510080
Affiliated Hospital of Inner Mongolia Med U
Hohhot, China, 10000
Shanghai Ruijin Hospital
Shanghai, China, 200025
Tianjin Medical University General Hospital
Tianjin, China, 300052
Tongji Hospital of Tongji Medical College of Huangzhong Univ
Wuhan, China, 430030
The 1st affiliated Hospital of Xi'an Traffic University
Xi'an, China, 710061
Colombia
Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
Bogotá, Colombia, 110221
IPS Medicity SAS
Bucaramanga, Colombia
Servimed S.A.S
Bucaramanga, Colombia
Preventive Care Ltda
Chia, Colombia, 250001
Clinica Universitaria Bolivariana
Medellin, Colombia, 050034
Funcentra
Montería, Colombia, 230002
Germany
Charite - Universitatsmedizin Berlin (CCM)
Berlin, Germany, 10117
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Rheumazentrum Ruhrgebiet
Herne, Germany, 44649
Rheumatology Unit
Leipzig, Germany, 04103
Universitaetsmedizin Mainz
Mainz, Germany, 55131
Hungary
Szt, Istvan and Szt. Laszlo
Budapest, Hungary, 1097
Bekes Megyei Pandy Kalman Korhaz
Gyula, Hungary, 5700
Leda Private Clinic
Zalaegerszeg, Hungary, H-8900
Japan
Chiba University Hospital
Chiba, Japan, 260-8677
Chiba East Hospital
Chiba, Japan, 260-8712
Kyushu Medical Center
Fukuoka, Japan, 810-8563
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Japan, 730-8619
Hospital of the University of Occupational and Enviromental Health
Hukuoka, Japan, 807-8555
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Japan, 586-8521
Kawasaki Rheumatism and Internal Medicine Clinic
Kitakyushu, Japan, 807-0856
Toho University Medical Center, Ohashi Hospital
Meguro-ku, Japan, 153-8515
Nagasaki University Hospital
Nagasaki, Japan, 852-8501
National Hospital Organization Nagoya Medical Center
Nagoya, Japan, 460-0001
Kitasato University Hospital
Sagamihara, Japan, 252-0375
Sapporo City General Hospital
Sapporo, Japan, 060-8604
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Sasebo Chuo Hospital
Sasebo, Japan, 857-1165
Tohoku University Hospital
Sendai, Japan, 980-8574
Keio University Hospital
Shinjuku-ku, Japan, 160-8582
National Center for Global Health and Medicine
Shinjuku-ku, Japan, 162-8655
St. Luke's International Hospital
Tokyo, Japan, 104-8560
Juntendo University Hospital
Tokyo, Japan, 113-8431
Fujita Health University Hospital
Toyoake, Japan, 470-1192
Yokohama Medical Center
Yokohama, Japan, 236-0037
Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of, 705-718
Chonbuk National Univ Hospital
JeonJu, Korea, Republic of, 54907
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Konkuk University Medical Center
Seoul, Korea, Republic of, 05030
Ajou University Hospital
Suwon, Korea, Republic of, 16499
Lithuania
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas, Lithuania, LT-50161
Klaipeda University Hospital
Klaipeda, Lithuania, LT-92288
Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil
Vilnius, Lithuania, 08406
Vilnius University Hospital Santariskiu Clinics
Vilnius, Lithuania, LT-08661
Poland
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, Poland, 85-168
Nzoz Bif-Med
Bytom, Poland, 41-902
Centrum Medyczne AMED oddzial w Lodzi
Lodz, Poland, 91-363
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland, 20-954
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, Poland, 67-100
Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska
Sonoswiec, Poland, 41-200
Centrum Medyczne Pratia Tychy
Tychy, Poland, 43-100
Centrum Medyczne Pratia Warszawa
Warszawa, Poland, 01-868
Reumatika-Centrum Reumatologii, NZOZ
Warszawa, Poland, 02-691
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, Poland, 50-556
Portugal
Instituto Portugues de Reumatologia
Lisboa, Portugal, 1050-034
Hospital Curry Cabral-Centro Hospital Lisboa Central
Lisboa, Portugal, 1069-166
Hospital da Luz
Lisboa, Portugal, 1500-650
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, Portugal, 4990-041
C.H. de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Portugal, 4434-502
Russian Federation
Regional Clinical Hospital for War Veterans
Kemerovo, Russian Federation, 650000
LLL Medical Center Revma-Med
Kemerovo, Russian Federation, 650070
Clinical Diagnostic Center 'Ultramed'
Omsk, Russian Federation, 644024
Leningrad region clinical hospital
Saint-Petersburg, Russian Federation, 194291
City Clinical Hospital #31
St. Petersburg, Russian Federation, 197110
Northen-Western State Medical University n.a. I.I. Mechnikov
St.-Petersburg, Russian Federation, 191015
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Russian Federation, 432063
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, Russian Federation, 150003
Serbia
Institute of Rheumatology Belgrade
Belgrade, Serbia, 11000
Institute of Rheumatology
Belgrade, Serbia, 11000
Military Medical Academy
Belgrade, Serbia, 11000
Clinical Hospital Center Bezanijska Kosa
Belgrade, Serbia, 11080
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Institute for Treatment and Rehabilitation Niska Banja
Niska Banja, Serbia, 18205
Clinical Center of Vojvodina
Vojvodina, Serbia, 21000
South Africa
Panorama Medical Centre
Cape Town, South Africa, 7500
Excellentis Clinical trial Consultants
George, South Africa, 6529
Clinical Research Unit, University of Pretoria
Pretoria, South Africa, 0002
Winelands Medical Research Centre
Stellenbosch, South Africa, 7613
Spain
Hosp. Univ. Vall D'Hebron
Barcelona, Spain, 8035
Hosp. Univ. de Basurto
Bilbao, Spain, 48013
Hosp. Reina Sofia
Cordoba, Spain, 14004
Hosp. Clinico San Carlos
Madrid, Spain, 28040
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Hosp. Regional Univ. de Malaga
Málaga, Spain, 29009
Hosp. Univ. Infanta Sofia
San Sebastián de los Reyes, Spain, 28702
Hosp. Infanta Luisa
Sevilla, Spain, 41010
Hosp. Do Meixoeiro
Vigo -Pontevedra, Spain, 36214
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Chang Gung Memorial Hospital
Kwei-san Hsiang, Taiwan, 333
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
China Medical University Hospital
Taichung, Taiwan, 40447
National Taiwan University Hospital
Taipei, Taiwan, 10043
Cathay General Hospital
Taipei, Taiwan, 10601
Taipei Medical University
Taipei, Taiwan, 11031
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Thailand
Phramongkutklao Hospital and Medical College
Bangkok, Thailand, 10400
Rajavhiti Hospital
Bangkok, Thailand, 10400
Ramathibodi Hospital
Bangkok, Thailand, 10400
Siriraj Hospital
Bangkok, Thailand, 10700
Songklanagarind hospital
Hat Yai, Thailand, 90110
Chiang Mai University
Muang, Thailand, 50200
Ukraine
Mechnikov Inst, Miska bagatoprofilna likarnia #18
Kharkiv, Ukraine, 61029
Kyiv City Clinical Hospital #3
Kyiv, Ukraine, 02125
Kyivska oblasna klinichna likarnia
Kyiv, Ukraine, 4107
Odeska oblasna klinichna likarnia
Odesa, Ukraine, 65025
Multidisciplinary Medical Center of Odessa National Medical University (University Clinic №1)
Odessa, Ukraine, 65026
Vinnytsya regional clinical hospital n.a.Pyrogov, VNMU
Vinnytsia, Ukraine, 21018
Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
Vinnytsia, Ukraine, 21029
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03517722    
Other Study ID Numbers: CR108440
2017-001489-53 ( EudraCT Number )
CNTO1275SLE3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ustekinumab
Dermatologic Agents