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A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Primary Purpose

Lupus Erythematosus, Systemic

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Ustekinumab (approximately 6 mg/kg)
Ustekinumab 90 mg
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pinnacle Research Group, LLC
  • University of Alabama at Birmingham
  • Achieve Clinical Research, LLC
  • Medvin Clinical Research
  • Lugene Eye Institute
  • C.V. Mehta, MD Medical Corp.
  • University of California at San Diego
  • Advanced Medical Research - Lakewood
  • Loma Linda University
  • Loma Linda University Health Care
  • Valerius Medical Group & Research Center
  • Keck School of Medicine of USC
  • Wallace Rheumatic Study Center
  • East Bay Rheumatology Medical Group
  • Westlake Medical Research Clinical Trials
  • University Clinical Investigators, Inc
  • Inland Rheumatology Clinical Trials Inc.
  • University of Colorado
  • Denver Arthritis Clinic
  • UPMC Lupus Center of Excellence
  • Stamford Therapeutics Consortium
  • Arthritis and Rheumatic Disease Specialties
  • Bay Area Arthritis and Osteoporosis
  • Centre for Rheumatology, Immunology and Arthritis
  • University of Florida Health Jacksonville - Rheumatology
  • University of Miami Miller School of Medicine
  • New Horizon Research Center
  • Rheumatology Associates of Central Florida, PA
  • Omega Research Consultants
  • Millennium Research
  • Integral Rheumatology & Immunology Specialists
  • Clinical Research of West Florida
  • Emory University
  • Piedmont Healthcare - Piedmont Hospital
  • DeKalb Medical Specialty Center
  • Rush University Medical Center
  • University of Chicago
  • Graves-Gilbert Clinic - Bowling Green
  • Arthritis and Diabetes Clinic
  • The Center for Rheumatology and Bone Research
  • June DO, PC.
  • St Paul Rheumatology PA
  • University of Mississippi Medical Center
  • Oklahoma Medical Research Foundation
  • Innovative Health Research
  • Albuquerque Center for Rheumatology
  • Biomedical Research Alliance Of New York
  • The Feinstein Institute for Medical Research
  • NYU Center for Musculoskeletal Care
  • Hospital for Special Surgery
  • SUNY Upstate Medical University
  • Joint and Muscle Research Institute
  • DJL Clinical Research, PLLC
  • Duke University Medical Center
  • Wake Forest Baptist Medical Center
  • OK Center for Arthritis Therapy & Research, Inc.
  • Lewis Katz School of Medicine, Temple University
  • Allegheny Rheumatology/Allegheny Singer Research Institute
  • Columbia Arthritis Center
  • West Tennessee Research Institute
  • Dr. Ramesh Gupta
  • Vanderbilt University Medical Center
  • Amarillo Center for Clinical Research
  • Austin Regional Clinic
  • Arthritis Centers of Texas
  • Sun Research Institute
  • UT Health Science Center at San Antonio
  • University of Washington
  • Rheumatology & Pulmonary Clinic
  • Fundación CENIT para la Investigación en Neurociencias
  • Instituto Centenario
  • Centro Privado de Medicina Familiar
  • Framingham Centro Medico
  • Hospital Italiano de Cordoba
  • Hospital Escuela 'Gral. Jose F. de San Martin'
  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
  • Centro Medico Privado de Reumatologia
  • MHAT Trimantium
  • Diagnostic-Consultative Center (DCC) Aleksandrovska
  • UMHAT St. Ivan Rilski
  • Medical Centre Synexus
  • University of Calgary
  • University of Manitoba
  • Toronto Western Hospital
  • McMaster University
  • CHU de Québec
  • The First Affiliated Hospital of Baotou Medical University
  • Peking Union Medical College Hospital
  • West China Hospital, Sichuan University
  • Guangdong Provincial People's Hospital
  • Affiliated Hospital of Inner Mongolia Med U
  • Shanghai Ruijin Hospital
  • Tianjin Medical University General Hospital
  • Tongji Hospital of Tongji Medical College of Huangzhong Univ
  • The 1st affiliated Hospital of Xi'an Traffic University
  • Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
  • IPS Medicity SAS
  • Servimed S.A.S
  • Preventive Care Ltda
  • Clinica Universitaria Bolivariana
  • Funcentra
  • Charite - Universitatsmedizin Berlin (CCM)
  • Medizinische Hochschule Hannover
  • Rheumazentrum Ruhrgebiet
  • Rheumatology Unit
  • Universitaetsmedizin Mainz
  • Szt, Istvan and Szt. Laszlo
  • Bekes Megyei Pandy Kalman Korhaz
  • Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)
  • Chiba University Hospital
  • National Hospital Organization Chibahigashi National Hospital
  • National Hospital Organization Kyushu Medical Center
  • Fukushima Medical University Hospital
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
  • Hospital of the University of Occupational and Environmental Health
  • National Hospital Organization Osaka Minami Medical Center
  • Kawasaki Rheumatism and Internal Medicine Clinic
  • Toho University Medical Center, Ohashi Hospital
  • Nagasaki University Hospital
  • National Hospital Organization Nagoya Medical Center
  • Kitasato University Hospital
  • Hokkaido University Hospital
  • Sapporo City General Hospital
  • Sasebo Chuo Hospital
  • Tohoku University Hospital
  • Keio University Hospital
  • National Center for Global Health and Medicine
  • St. Luke's International Hospital
  • Juntendo University Hospital
  • Fujita Health University Hospital
  • National Hospital Organization Yokohama Medical Center
  • Daegu Catholic University Medical Center
  • Chonbuk National Univ Hospital
  • Seoul National University Hospital
  • Konkuk University Medical Center
  • Ajou University Hospital
  • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
  • Klaipeda University Hospital
  • Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil
  • Vilnius University Hospital Santariskiu Clinics
  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
  • Nzoz Bif-Med
  • Centrum Medyczne AMED oddzial w Lodzi
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska
  • Centrum Medyczne Pratia Tychy
  • Centrum Medyczne Pratia Warszawa
  • Reumatika-Centrum Reumatologii, NZOZ
  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
  • Instituto Portugues de Reumatologia
  • Hospital Curry Cabral-Centro Hospital Lisboa Central
  • Hospital da Luz
  • ULSAM, EPE - Hospital Conde de Bertiandos
  • C.H. de Vila Nova de Gaia/Espinho
  • Regional Clinical Hospital for War Veterans
  • LLL Medical Center Revma-Med
  • Clinical Diagnostic Center 'Ultramed'
  • Leningrad region clinical hospital
  • City Clinical Hospital #31
  • Northen-Western State Medical University n.a. I.I. Mechnikov
  • Ulyanovsk Regional Clinical Hospital
  • Clinical Emergency Hospital n.a. N.V. Solovyev
  • Institute of Rheumatology Belgrade
  • Institute of Rheumatology
  • Military Medical Academy
  • Clinical Hospital Center Bezanijska Kosa
  • University Clinical Center Kragujevac
  • Institute for Treatment and Rehabilitation Niska Banja
  • Clinical Center of Vojvodina
  • Panorama Medical Centre
  • Excellentis Clinical trial Consultants
  • Clinical Research Unit, University of Pretoria
  • Winelands Medical Research Centre
  • Hosp. Univ. Vall D Hebron
  • Hosp. Univ. de Basurto
  • Hosp. Reina Sofia
  • Hosp. Clinico San Carlos
  • Hosp. Univ. 12 de Octubre
  • Hosp. Regional Univ. de Malaga
  • Hosp. Univ. Infanta Sofia
  • Hosp. Infanta Luisa
  • Hosp. Do Meixoeiro
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Chang Gung Memorial Hospital
  • Chung Shan Medical University Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Cathay General Hospital
  • Taipei Medical University
  • Taipei Veterans General Hospital
  • Phramongkutklao Hospital and Medical College
  • Rajavhiti Hospital
  • Ramathibodi Hospital
  • Siriraj Hospital
  • Songklanagarind hospital
  • Chiang Mai University
  • Mechnikov Inst, Miska bagatoprofilna likarnia #18
  • Kyiv City Clinical Hospital #3
  • Kyivska oblasna klinichna likarnia
  • Odeska oblasna klinichna likarnia
  • Multidisciplinary Medical Center of Odessa National Medical University
  • MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
  • Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ustekinumab

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52
SRI-4 response:>=4-point reduction in SLEDAI-2K total score, no British Isles Lupus Assessment Group (BILAG) A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in Physician's Global Assessment(PGA).SLEDAI measures disease activity in 9 organ systems,higher scores=more severe disease activity.Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).

Secondary Outcome Measures

Time to First Flare
Time to flare is defined as the time (in days) post baseline when the first flare occurs. It was calculated with flare defined as either 1 or more BILAG A (severe disease activity) or 2 or more new BILAG B (moderate disease activity) domain scores relative to baseline. BILAG was defined as a measure of alterations or intensification to therapy consisting of 97 questions in 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. BILAG A flare was defined as at least 1 new BILAG A scores. BILAG B flare was defined as at least 2 new BILAG B scores.
Percentage of Participants With an SRI-4 Composite Response at Week 24
SRI-4 response:>=4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no BILAG A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in PGA.SLEDAI measures disease activity in 9 organ systems, higher scores=more severe disease activity. Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).
Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52
The percentage of participants who achieved at least 50% improvement from baseline in number of joints with pain and signs of inflammation at Week 52 for participants with at least 4 joints with pain and signs of inflammation at baseline were reported.
Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52
Reduction of glucocorticoid dose was 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 was reduced to less than or equal to (<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.
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
Percentage of participants achieving at least 50% improvement in CLASI activity score at Week 52 reported in participants with a CLASI activity score of 4 or greater at baseline. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI activity score ranges from 0-70 with lower score being improved. Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia.
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
Percentage of participants with reduction in glucocorticoid dose by Week 40, its sustenance through Week 52, and SRI 4 composite response at Week 52 were reported. Reduction of glucocorticoid dose was defined as reduction in average daily oral glucocorticoid dose by at least 50% (relative to baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to baseline dose) so that average daily dose is reduced to <=7.5 mg (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who,at baseline,were receiving oral glucocorticoids. SRI-4 was defined as composite of at least 4-point improvement in SLEDAI-2K score of 0=no symptoms to 105=presence of all defined symptoms with higher scores representing increased disease activity),no worsening in BILAG and no worsening in PGA.

Full Information

First Posted
April 13, 2018
Last Updated
January 31, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03517722
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early as a result of the outcome of the pre-planned Interim Analysis
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ustekinumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo matching to ustekinumab IV or SC.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab (approximately 6 mg/kg)
Other Intervention Name(s)
Stelara
Intervention Description
Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 90 mg
Other Intervention Name(s)
Stelara
Intervention Description
Participants will receive 90 mg ustekinumab via SC route.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52
Description
SRI-4 response:>=4-point reduction in SLEDAI-2K total score, no British Isles Lupus Assessment Group (BILAG) A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in Physician's Global Assessment(PGA).SLEDAI measures disease activity in 9 organ systems,higher scores=more severe disease activity.Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Time to First Flare
Description
Time to flare is defined as the time (in days) post baseline when the first flare occurs. It was calculated with flare defined as either 1 or more BILAG A (severe disease activity) or 2 or more new BILAG B (moderate disease activity) domain scores relative to baseline. BILAG was defined as a measure of alterations or intensification to therapy consisting of 97 questions in 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. BILAG A flare was defined as at least 1 new BILAG A scores. BILAG B flare was defined as at least 2 new BILAG B scores.
Time Frame
Up to Week 52
Title
Percentage of Participants With an SRI-4 Composite Response at Week 24
Description
SRI-4 response:>=4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no BILAG A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in PGA.SLEDAI measures disease activity in 9 organ systems, higher scores=more severe disease activity. Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).
Time Frame
Week 24
Title
Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52
Description
The percentage of participants who achieved at least 50% improvement from baseline in number of joints with pain and signs of inflammation at Week 52 for participants with at least 4 joints with pain and signs of inflammation at baseline were reported.
Time Frame
Week 52
Title
Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52
Description
Reduction of glucocorticoid dose was 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 was reduced to less than or equal to (<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.
Time Frame
Up to Week 52
Title
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
Description
Percentage of participants achieving at least 50% improvement in CLASI activity score at Week 52 reported in participants with a CLASI activity score of 4 or greater at baseline. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI activity score ranges from 0-70 with lower score being improved. Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia.
Time Frame
Week 52
Title
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
Description
Percentage of participants with reduction in glucocorticoid dose by Week 40, its sustenance through Week 52, and SRI 4 composite response at Week 52 were reported. Reduction of glucocorticoid dose was defined as reduction in average daily oral glucocorticoid dose by at least 50% (relative to baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to baseline dose) so that average daily dose is reduced to <=7.5 mg (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who,at baseline,were receiving oral glucocorticoids. SRI-4 was defined as composite of at least 4-point improvement in SLEDAI-2K score of 0=no symptoms to 105=presence of all defined symptoms with higher scores representing increased disease activity),no worsening in BILAG and no worsening in PGA.
Time Frame
Up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: Met a total of at least 4 SLICC criteria, including at least 1 clinical and at least 1 immunologic; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Vestavia Hills
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
C.V. Mehta, MD Medical Corp.
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
University of California at San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Advanced Medical Research - Lakewood
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
Loma Linda University Health Care
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
Valerius Medical Group & Research Center
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Wallace Rheumatic Study Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
East Bay Rheumatology Medical Group
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Westlake Medical Research Clinical Trials
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
University Clinical Investigators, Inc
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Inland Rheumatology Clinical Trials Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
UPMC Lupus Center of Excellence
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Arthritis and Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Bay Area Arthritis and Osteoporosis
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Centre for Rheumatology, Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
University of Florida Health Jacksonville - Rheumatology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1002
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Rheumatology Associates of Central Florida, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Piedmont Healthcare - Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
DeKalb Medical Specialty Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Graves-Gilbert Clinic - Bowling Green
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Arthritis and Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
June DO, PC.
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910-8595
Country
United States
Facility Name
St Paul Rheumatology PA
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Innovative Health Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Albuquerque Center for Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Biomedical Research Alliance Of New York
City
Lake Success
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Center for Musculoskeletal Care
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Joint and Muscle Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
OK Center for Arthritis Therapy & Research, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Lewis Katz School of Medicine, Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny Rheumatology/Allegheny Singer Research Institute
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Columbia Arthritis Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Dr. Ramesh Gupta
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-3103
Country
United States
Facility Name
Amarillo Center for Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Arthritis Centers of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
UT Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78239
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Rheumatology & Pulmonary Clinic
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1025ABI
Country
Argentina
Facility Name
Instituto Centenario
City
Buenos Aires
ZIP/Postal Code
C1204AAP
Country
Argentina
Facility Name
Centro Privado de Medicina Familiar
City
Buenos Aires
ZIP/Postal Code
C1417EYG
Country
Argentina
Facility Name
Framingham Centro Medico
City
Ciudad De La Plata
ZIP/Postal Code
B1902COS
Country
Argentina
Facility Name
Hospital Italiano de Cordoba
City
Cordoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Facility Name
Hospital Escuela 'Gral. Jose F. de San Martin'
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
City
San Juan
ZIP/Postal Code
J5402DIL
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel de Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
MHAT Trimantium
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Diagnostic-Consultative Center (DCC) Aleksandrovska
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT St. Ivan Rilski
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Medical Centre Synexus
City
Sofia
ZIP/Postal Code
1709
Country
Bulgaria
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
McMaster University
City
Hamilton
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
CHU de Québec
City
Quebec
ZIP/Postal Code
G1V-2L9
Country
Canada
Facility Name
The First Affiliated Hospital of Baotou Medical University
City
Baotou
ZIP/Postal Code
014010
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Affiliated Hospital of Inner Mongolia Med U
City
Hohhot
ZIP/Postal Code
10000
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tongji Hospital of Tongji Medical College of Huangzhong Univ
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
The 1st affiliated Hospital of Xi'an Traffic University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
IPS Medicity SAS
City
Bucaramanga
Country
Colombia
Facility Name
Servimed S.A.S
City
Bucaramanga
Country
Colombia
Facility Name
Preventive Care Ltda
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Clinica Universitaria Bolivariana
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Facility Name
Funcentra
City
Montería
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Charite - Universitatsmedizin Berlin (CCM)
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Rheumatology Unit
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsmedizin Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Szt, Istvan and Szt. Laszlo
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Bekes Megyei Pandy Kalman Korhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)
City
Zalaegerszeg
ZIP/Postal Code
H-8900
Country
Hungary
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
National Hospital Organization Chibahigashi National Hospital
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health
City
Hukuoka
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
National Hospital Organization Osaka Minami Medical Center
City
Kawachi-Nagano
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Kawasaki Rheumatism and Internal Medicine Clinic
City
Kitakyushu
ZIP/Postal Code
807-0856
Country
Japan
Facility Name
Toho University Medical Center, Ohashi Hospital
City
Meguro-ku
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Sapporo City General Hospital
City
Sapporo
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
Sasebo Chuo Hospital
City
Sasebo
ZIP/Postal Code
857-1165
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
National Center for Global Health and Medicine
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center
City
Yokohama
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Daegu Catholic University Medical Center
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Chonbuk National Univ Hospital
City
JeonJu
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Facility Name
Klaipeda University Hospital
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil
City
Vilnius
ZIP/Postal Code
08406
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinics
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Nzoz Bif-Med
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Centrum Medyczne AMED oddzial w Lodzi
City
Lodz
ZIP/Postal Code
91-363
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska
City
Sonoswiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Centrum Medyczne Pratia Tychy
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Reumatika-Centrum Reumatologii, NZOZ
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Instituto Portugues de Reumatologia
City
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Hospital Curry Cabral-Centro Hospital Lisboa Central
City
Lisboa
ZIP/Postal Code
1069-166
Country
Portugal
Facility Name
Hospital da Luz
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
ULSAM, EPE - Hospital Conde de Bertiandos
City
Ponte de Lima
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
C.H. de Vila Nova de Gaia/Espinho
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Regional Clinical Hospital for War Veterans
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
LLL Medical Center Revma-Med
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Facility Name
Clinical Diagnostic Center 'Ultramed'
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
Leningrad region clinical hospital
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
City Clinical Hospital #31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Northen-Western State Medical University n.a. I.I. Mechnikov
City
St.-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Clinical Emergency Hospital n.a. N.V. Solovyev
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Institute of Rheumatology Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
University Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Institute for Treatment and Rehabilitation Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Clinical Center of Vojvodina
City
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Panorama Medical Centre
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Excellentis Clinical trial Consultants
City
George
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Clinical Research Unit, University of Pretoria
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Winelands Medical Research Centre
City
Stellenbosch
ZIP/Postal Code
7613
Country
South Africa
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hosp. Univ. de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hosp. Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Regional Univ. de Malaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Hosp. Univ. Infanta Sofia
City
San Sebastián de los Reyes
ZIP/Postal Code
28702
Country
Spain
Facility Name
Hosp. Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Hosp. Do Meixoeiro
City
Vigo -Pontevedra
ZIP/Postal Code
36214
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Kwei-san Hsiang
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10043
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
ZIP/Postal Code
10601
Country
Taiwan
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Phramongkutklao Hospital and Medical College
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Rajavhiti Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Songklanagarind hospital
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Chiang Mai University
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Mechnikov Inst, Miska bagatoprofilna likarnia #18
City
Kharkiv
ZIP/Postal Code
61029
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #3
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Kyivska oblasna klinichna likarnia
City
Kyiv
ZIP/Postal Code
4107
Country
Ukraine
Facility Name
Odeska oblasna klinichna likarnia
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Multidisciplinary Medical Center of Odessa National Medical University
City
Odessa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
35798534
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 Jul 7;81(11):1556-63. doi: 10.1136/ard-2022-222858. Online ahead of print.
Results Reference
derived
PubMed Identifier
33687069
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.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=CR108440&amp;attachmentIdentifier=e67c0fcb-bac3-4351-a715-45375e8b9704&amp;fileName=2017-001489-53___Receipt.png&amp;versionIdentifier=
Description
Related Info

Learn more about this trial

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

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