Study Stopped
Study terminated early as a result of the outcome of the pre-planned Interim Analysis
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
3 other identifiers
interventional
516
20 countries
204
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2018
Typical duration for phase_3
204 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2018
CompletedStudy Start
First participant enrolled
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
May 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2020
CompletedResults Posted
Study results publicly available
March 9, 2022
CompletedApril 29, 2025
April 1, 2025
2.6 years
April 13, 2018
November 3, 2021
April 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Week 52
Secondary Outcomes (6)
Time to First Flare
Up to Week 52
Percentage of Participants With an SRI-4 Composite Response at Week 24
Week 24
Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52
Week 52
Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52
Up to Week 52
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
Week 52
- +1 more secondary outcomes
Study Arms (2)
Ustekinumab
EXPERIMENTALParticipants 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.
Placebo
EXPERIMENTALParticipants 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.
Interventions
Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.
Participants will receive 90 mg ustekinumab via SC route.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (204)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Achieve Clinical Research, LLC
Vestavia Hills, Alabama, 35216, United States
Medvin Clinical Research
Covina, California, 91722, United States
Lugene Eye Institute
Glendale, California, 91204, United States
C.V. Mehta, MD Medical Corp.
Hemet, California, 92543, United States
University of California at San Diego
La Jolla, California, 92093, United States
Advanced Medical Research - Lakewood
Lakewood, California, 90712, United States
Loma Linda University
Loma Linda, California, 92350, United States
Loma Linda University Health Care
Loma Linda, California, 92357, United States
Valerius Medical Group & Research Center
Los Alamitos, California, 90720, United States
Keck School of Medicine of USC
Los Angeles, California, 90033, United States
Wallace Rheumatic Study Center
Los Angeles, California, 90048, United States
East Bay Rheumatology Medical Group
San Leandro, California, 94578, United States
Westlake Medical Research Clinical Trials
Thousand Oaks, California, 91360, United States
University Clinical Investigators, Inc
Tustin, California, 92780, United States
Inland Rheumatology Clinical Trials Inc.
Upland, California, 91786, United States
University of Colorado
Aurora, Colorado, 80045, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
UPMC Lupus Center of Excellence
New Haven, Connecticut, 06520, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33309, United States
University of Florida Health Jacksonville
Jacksonville, Florida, 32207, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136-1002, United States
New Horizon Research Center
Miami, Florida, 33175, United States
Rheumatology Associates of Central Florida, PA
Orlando, Florida, 32806, United States
Omega Research Consultants
Orlando, Florida, 32810, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Integral Rheumatology And Immunology Specialists
Plantation, Florida, 33324, United States
Clinical Research of West Florida
Tampa, Florida, 33603, United States
Emory University
Atlanta, Georgia, 30303, United States
Piedmont Healthcare - Piedmont Hospital
Atlanta, Georgia, 30309, United States
DeKalb Medical Specialty Center
Decatur, Georgia, 30033, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Graves-Gilbert Clinic - Bowling Green
Bowling Green, Kentucky, 42101, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
June DO, PC.
Lansing, Michigan, 48910-8595, United States
St Paul Rheumatology PA
Eagan, Minnesota, 55121, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Oklahoma Medical Research Foundation
Las Vegas, Nevada, 89102, United States
Innovative Health Research
Las Vegas, Nevada, 89128, United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102, United States
Biomedical Research Alliance Of New York
Lake Success, New York, 10075, United States
The Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
NYU Center for Musculoskeletal Care
New York, New York, 10016, United States
Hospital for Special Surgery
New York, New York, 10021, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
OK Center for Arthritis Therapy & Research, Inc.
Tulsa, Oklahoma, 74104, United States
Lewis Katz School of Medicine, Temple University
Philadelphia, Pennsylvania, 19140, United States
Allegheny Rheumatology/Allegheny Singer Research Institute
Wexford, Pennsylvania, 15090, United States
Columbia Arthritis Center
Columbia, South Carolina, 29204, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Dr. Ramesh Gupta
Memphis, Tennessee, 38119, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-3103, United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124, United States
Austin Regional Clinic
Austin, Texas, 78731, United States
Arthritis Centers of Texas
Dallas, Texas, 75246, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
UT Health Science Center at San Antonio
San Antonio, Texas, 78239, United States
University of Washington
Seattle, Washington, 98195, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801, United States
Fundacion CENIT para la Investigacion en Neurociencias
Buenos Aires, C1025ABI, Argentina
Instituto Centenario
Buenos Aires, C1204AAP, Argentina
Centro Privado de Medicina Familiar
Buenos Aires, C1417EYG, Argentina
Framingham Centro Medico
Ciudad de La Plata, B1902COS, Argentina
Hospital Escuela 'Gral. Jose F. de San Martin'
Corrientes, 3400, Argentina
Hospital Italiano de Cordoba
Córdoba, X5004BAL, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, J5402DIL, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, T4000AXL, Argentina
MHAT Trimantium
Plovdiv, 4000, Bulgaria
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, 1431, Bulgaria
UMHAT St. Ivan Rilski
Sofia, 1612, Bulgaria
Medical Centre Synexus
Sofia, 1709, Bulgaria
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
University of Manitoba
Winnipeg, Manitoba, R3A 1M4, Canada
McMaster University
Hamilton, Ontario, L8N 3Z5, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
CHU de Québec
Québec, Quebec, G1V-2L9, Canada
The First Affiliated Hospital of Baotou Medical University
Baotou, 014010, China
Peking Union Medical College Hospital
Beijing, 100730, China
West China Hospital Sichuan University
Chengdu, 610041, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
Affiliated Hospital of Inner Mongolia Med U
Hohhot, 10000, China
Shanghai Ruijin Hospital
Shanghai, 200025, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Tongji Hospital of Tongji Medical College of Huangzhong Univ
Wuhan, 430030, China
The 1st affiliated Hospital of Xi'an Traffic University
Xi'an, 710061, China
Centro de Investigación en Reumatología y especialidades médicas S.A.S. - CIREEM S.A.S.
Bogotá, 110221, Colombia
IPS Medicity SAS
Bucaramanga, Colombia
Servimed S A S
Bucaramanga, Colombia
Preventive Care Ltda
Chía, 250001, Colombia
Clinica Universitaria Bolivariana
Medellín, 050034, Colombia
Funcentra
Montería, 230002, Colombia
Charite - Universitaetsmedizin Berlin (CCM)
Berlin, 10117, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Rheumazentrum Ruhrgebiet
Herne, 44649, Germany
Rheumatology Unit
Leipzig, 04103, Germany
Universitaetsmedizin Mainz
Mainz, 55131, Germany
Szt, Istvan and Szt. Laszlo
Budapest, 1097, Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, 5700, Hungary
Belvarosi Egeszseghaz Kft. (Leda-Platan Maganklinika es Sebeszeti Kozpont)
Zalaegerszeg, H-8900, Hungary
Chiba University Hospital
Chiba, 260 8677, Japan
National Hospital Organization Chiba East Hospital
Chiba, 260-8712, Japan
Hospital of the University of Occupational and Enviromental Health
Fukuoka, 807-8555, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Fukushima Medical University Hospital
Fukushima, 960 1295, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-8619, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, 586 8521, Japan
Kawasaki Rheumatism and Internal Medicine Clinic
Kitakyushu, 807-0856, Japan
Toho University Medical Center, Ohashi Hospital
Meguro-ku, 153-8515, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001, Japan
Kitasato University Hospital
Sagamihara, 252-0375, Japan
Sapporo City General Hospital
Sapporo, 060-8604, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Sasebo Chuo Hospital
Sasebo, 857 1195, Japan
Tohoku University Hospital
Sendai, 980 8574, Japan
Keio University Hospital
Shinjuku-ku, 160-8582, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, 162-8655, Japan
St. Luke's International Hospital
Tokyo, 104 8560, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Fujita Health University Hospital
Toyoake, 470-1192, Japan
National Hospital Organization Yokohama Medical Center
Yokohama, 245-8575, Japan
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas, LT-50161, Lithuania
Klaipeda University Hospital
Klaipėda, LT-92288, Lithuania
Vaiku ligonine Vilniaus Universiteto ligon. Santariskiu fil
Vilnius, 08406, Lithuania
Vilnius University Hospital Santariskiu Clinics
Vilnius, LT-08661, Lithuania
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Nzoz Bif Med
Bytom, 41 902, Poland
Centrum Medyczne AMED oddzial w Lodzi
Lodz, 91 363, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, 67-100, Poland
Centrum Medyczne Medens S.C. Grupowa Praktyka Lekarska
Sonoswiec, 41-200, Poland
Centrum Medyczne Pratia Tychy
Tychy, 43-100, Poland
Centrum Medyczne Pratia Warszawa
Warsaw, 01-868, Poland
Reumatika-Centrum Reumatologii, NZOZ
Warsaw, 02-691, Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, 50-556, Poland
Instituto Portugues de Reumatologia
Lisbon, 1050-034, Portugal
Uls Sao Jose - Hosp. Curry Cabral
Lisbon, 1069-166, Portugal
Hosp. Da Luz Lisboa
Lisbon, 1500 650, Portugal
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, 4990-041, Portugal
C.H. de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, 4434-502, Portugal
Regional Clinical Hospital for War Veterans
Kemerovo, 650000, Russia
LLL Medical Center Revma-Med
Kemerovo, 650070, Russia
Clinical Diagnostic Center 'Ultramed'
Omsk, 644024, Russia
Northen-Western State Medical University n.a. I.I. Mechnikov
Saint Petersburg, 191015, Russia
Leningrad region clinical hospital
Saint Petersburg, 194291, Russia
City Clinical Hospital #31
Saint Petersburg, 197110, Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, 432063, Russia
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, 150003, Russia
Institute of Rheumatology Belgrade
Belgrade, 11000, Serbia
Institute of Rheumatology
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080, Serbia
University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, 18205, Serbia
Clinical Center of Vojvodina
Vojvodina, 21000, Serbia
Panorama Medical Centre
Cape Town, 7500, South Africa
Excellentis Clinical trial Consultants
George, 6529, South Africa
Clinical Research Unit, University of Pretoria
Pretoria, 0002, South Africa
Winelands Medical Research Centre
Stellenbosch, 7613, South Africa
Daegu Catholic University Medical Center
Daegu, 705-718, South Korea
Chonbuk National Univ Hospital
Jeonju, 54907, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hosp Univ Vall D Hebron
Barcelona, 8035, Spain
Hosp. Univ. de Basurto
Bilbao, 48013, Spain
Hosp Reina Sofia
Córdoba, 14004, Spain
Hosp. Clinico San Carlos
Madrid, 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp Regional Univ de Malaga
Málaga, 29009, Spain
Hosp. Univ. Infanta Sofia
San Sebastián de los Reyes, 28702, Spain
Hosp. Infanta Luisa
Seville, 41010, Spain
Hosp. Do Meixoeiro
Vigo -Pontevedra, 36214, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Chang Gung Memorial Hospital
Kwei-san Hsiang, 333, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 10043, Taiwan
Cathay General Hospital
Taipei, 10601, Taiwan
Taipei Medical University
Taipei, 11031, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Phramongkutklao Hospital and Medical College
Bangkok, 10400, Thailand
Rajavhiti Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Songklanagarind hospital
Hat Yai, 90110, Thailand
Chiang Mai University
Muang, 50200, Thailand
Mechnikov Inst, Miska bagatoprofilna likarnia #18
Kharkiv, 61029, Ukraine
Kyiv City Clinical Hospital #3
Kyiv, 02125, Ukraine
Kyivska oblasna klinichna likarnia
Kyiv, 4107, Ukraine
Odeska oblasna klinichna likarnia
Odesa, 65025, Ukraine
Multidisciplinary Medical Center of Odessa National Medical University
Odesa, 65026, Ukraine
MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'
Vinnytsia, 21018, Ukraine
Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
Vinnytsia, 21029, Ukraine
Related Publications (2)
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.
PMID: 35798534DERIVEDHannon 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.
PMID: 33687069DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to study termination, the open-label extension phase didn't reach the planned duration till Week 176. However, participants were assessed for safety up to Week 130 (that is, after study termination) and received study drug up to Week 113.
Results Point of Contact
- Title
- DIRECTOR CLINICAL RESEARCH GI.
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2018
First Posted
May 7, 2018
Study Start
April 16, 2018
Primary Completion
November 5, 2020
Study Completion
November 5, 2020
Last Updated
April 29, 2025
Results First Posted
March 9, 2022
Record last verified: 2025-04