A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)
NCT ID: NCT03616964
Last Updated: 2022-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
778 participants
INTERVENTIONAL
2018-08-02
2021-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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2 milligram (mg) Baricitinib
Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks.
Baricitinib
Administered orally.
Placebo
Administered orally
4 mg Baricitinib
Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.
Baricitinib
Administered orally.
Placebo
Administered orally
Placebo
Participants received 2 placebo tablets: one placebo tablet matching 4 mg baricitinib and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.
Placebo
Administered orally
Interventions
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Baricitinib
Administered orally.
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
* Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
* Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
* Have a clinical SLEDAI-2K score ≥4 at randomization.
* Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.
* Are receiving at least one of the following standard of care medications for SLE:
* A single antimalarial at a stable dose for at least 8 weeks prior to screening
* A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
* An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)
Exclusion Criteria
* Have active central nervous system (CNS) lupus.
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
* Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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University of Arizona Arthritis Center
Gilbert, Arizona, United States
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P. C.
Tucson, Arizona, United States
Wallace Rheumatic Studies Center
Beverly Hills, California, United States
Medvin Clinical Research - Weidmann
Covina, California, United States
Office: Dr Robin K Dore
Tustin, California, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Tampa Medical Group, P.A.
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
North Georgia Rheumatology, PC
Lawrenceville, Georgia, United States
Arthritis Center of Lexington
Lexington, Kentucky, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Advanced Rheumatology, PC
Lansing, Michigan, United States
Glacier View Research Institute - Endocrinology
Kalispell, Montana, United States
Innovative Health Research
Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Arthritis and Osteoporosis Associates of New Mexico
Las Cruces, New Mexico, United States
St. Lawrence Health System
Canton, New York, United States
New York University Medical Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Joint and Muscle Medical Care
Charlotte, North Carolina, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte, North Carolina, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, United States
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
Summerville, South Carolina, United States
Eagle Medical
Crossville, Tennessee, United States
Dr. Dhiman Basu Private Practice
Colleyville, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, United States
Clear Lake Specialties
Webster, Texas, United States
Arthritis Clinic of Northern VA, P.C.
Arlington, Virginia, United States
Spectrum Medical Inc.
Danville, Virginia, United States
Aprillus Asistencia e Investigacion - Servicio de neurologia
CABA, Buenos Aires, Argentina
DOM Centro de Reumatologia
Ciudad de Buenos Aires, Buenos Aires, Argentina
Framingham Centro Medico
La Plata, Buenos Aires, Argentina
CER Instituto Medico
Quilmes, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, Argentina
Comite de Etica en Investigacion - CEMIC
Buenos Aires, Ciudad Autonoma de Buenos Aire, Argentina
Clinica Adventista Belgrano
CABA, Ciudad Autónoma de Buenos Aire, Argentina
Sanatorio Británico
Rosario, Santa Fe Province, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, Tucumán Province, Argentina
Sanatorio Guemes Cardiocirugia
Ciudad Autonoma Buenos Aires, , Argentina
IR Medical Center S.A. Instituto de Reumatologia
Mendoza, , Argentina
Clinical Research Chile SpA
Valdivia, Los Ríos Region, Chile
Enroll SpA
Providencia, Región Metropolitana de Santia, Chile
Clinica Alemana de Osorno
Osorno, , Chile
Sociedad Medica Del Aparato Locomotor SA
Santiago, , Chile
Prosalud y cia. Ltda.
Santiago, , Chile
ReumaCen Centro Reumatologico Integral
Viña del Mar, , Chile
HPTU-El Hospital con alma Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Circaribe SAS
Barranquilla, Atlántico, Colombia
Clinica de la Costa
Barranquilla, Atlántico, Colombia
Idearg S.A.S.
Bogota, Cundinamarca, Colombia
Centro Integral de Reumatologia e Inmunologia
Bogotá, Cundinamarca, Colombia
Servimed S.A.S.
Bucaramanga, Santander Department, Colombia
Centro de Medicina Interna
Cali, Valle del Cauca Department, Colombia
Preventive Care Ltdac
Chía, , Colombia
CHRU Brest - Hopital Cavale Blanche
Brest, Finistère, France
Centre hospitalier universitaire de Haut Leveque
Pessac, Gironde, France
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault, France
Centre hospitalier universitaire Pellegrin
Bordeaux, , France
Hopital Européen
Marseille, , France
Krishna Institute of Medical Science
Hyderabad, Andhra Pradesh, India
Panchshil Hospital
Ahmedabad, Gujarat, India
CIMS Hospital Private Limited
Ahmedabad, Gujarat, India
NHL Municipal Medical College & VS General Hospital
Ahmedabad, Gujarat, India
Shree Giriraj Hospital
Rajkot, Gujarat, India
Nirmal Hospital Private Limited
Surat, Gujarat, India
Sterling Hospital
Vadodara, Gujarat, India
St. John Medical College & Hospital
Bangalore, Karnataka, India
ChanRe Rheumatology And Immunology Center And Research
Bangalore, Karnataka, India
Sushruta Multispecialty Hospital & Research Center Pvt Ltd
Hubli, Karnataka, India
Kasturba Medical College Hospital, Mangalore
Madhav Nagar, Manipal, Karnataka, India
Jasleen Hospital
Nagpur, Maharashtra, India
Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
Nashik, Maharashtra, India
Fortis Escorts Hospital
Jaipur, Rajasthan, India
Azienda Ospedaliera Universitaria
Modena, MO, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, Tuscany, Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Policlinico Umberto I
Roma, , Italy
Azienda Ospedaliera Santa Maria Della Misericordia
Udine, , Italy
University of Occupational and Enviromental Health
Kitakyushu, Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Jp Red Cross Society Himeji Hp
Himeji, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
St. Lukes International Hospital
Chuo-Ku, Tokyo, Japan
Toho University Ohashi Med C
Meguro-ku, Tokyo, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Hamanomachi Hospital
Fukuoka, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
Mary Mediatrix Medical Center
Lipa, Batangas, Philippines
Cebu Doctors Hospital
Cebu City, Cebu, Philippines
Southern Philippines Medical Center
Davao City, Davao Del Norte, Philippines
Angeles University Foundation and Medical Center
Angeles City, Pampanga, Philippines
Chong Hua Medical Arts Center
Cebu City, , Philippines
Makati Medical Center
Makati City, , Philippines
St. Luke's Medical Center
Quenzon City, , Philippines
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, Poland
Medycyna Kliniczna
Warsaw, Masovian Voivodeship, Poland
Reumatika - Centrum Reumatologii
Warsaw, Masovian Voivodeship, Poland
Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
Bialystok, Podlaskie Voivodeship, Poland
Zespol Poradni Specjalistycznych REUMED
Lublin, Polska, Poland
Ambulatorium Barbara Bazela
Elblag, Warminsko-Mazurki, Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, , Poland
Centrum Medyczne Pratia Katowice
Katowice, , Poland
Malopolskie Centrum Medyczne S.C.
Krakow, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, , Poland
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu
Poznan, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Napoca Emergency Clinical County Hospital
Cluj-Napoca, Cluj, Romania
Craiova Emergency Clinical County Hospital
Craiova, Dolj, Romania
SC CMDTA Neomed SRL
Brasov, , Romania
Spitalul Clinic Sf Maria Bucuresti
Bucharest, , Romania
Spitalul Clinic "Dr. Ioan Cantacuzino"
Bucharest, , Romania
SANA Medical Center
Bucharest, , Romania
St. Maria Clinical Hospital
Bucharest, , Romania
Spitalul Euroclinic
Bucureti, , Romania
Institute of Rheumatology
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
University Clinical Center of Serbia
Belgrade, , Serbia
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, , Serbia
Clinical Center of Vojvodina
Novi Sad, , Serbia
Suite 509 Umhlanga Netcare Medical Centre
Umhlanga, Durban, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Guateng, South Africa
Jakaranda Hospital
Muckleneuk, Pretoria, South Africa
Panorama Medical Centre
Cape Town, Western Cape, South Africa
Arthritis Clinical Trial Centre
Pinelands, Western Cape, South Africa
Winelands Medical Research Centre
Stellenbosch, Western Cape, South Africa
University Of Pretoria
Pretoria, , South Africa
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Kyung Pook National University Hospital
Daegu, Korea, South Korea
Gachon University Gil Hospital
Incheon, Korea, South Korea
Hanyang University Medical Center
Seoul, Korea, South Korea
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu, Seoul, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Hospital Marina Baixa
Villajoyosa, Alicante, Spain
Hospital De Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital do Meixoeiro
Vigo, Pontevedra, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, Sapin, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Corporació Sanitària Clínic
Barcelona, , Spain
Hospital Quiron Infanta Luisa
Seville, , Spain
Countries
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References
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Yin J, Hou Y, Wang C, Qin C. Clinical outcomes of baricitinib in patients with systemic lupus erythematosus: Pooled analysis of SLE-BRAVE-I and SLE-BRAVE-II trials. PLoS One. 2025 Apr 30;20(4):e0320179. doi: 10.1371/journal.pone.0320179. eCollection 2025.
Petri M, Bruce IN, Dorner T, Tanaka Y, Morand EF, Kalunian KC, Cardiel MH, Silk ME, Dickson CL, Meszaros G, Zhang L, Jia B, Zhao Y, McVeigh CJ, Mosca M. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II). Lancet. 2023 Mar 25;401(10381):1011-1019. doi: 10.1016/S0140-6736(22)02546-6. Epub 2023 Feb 24.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Baricitinib in Participants With Systemic Lupus Erythematosus
Other Identifiers
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I4V-MC-JAIA
Identifier Type: OTHER
Identifier Source: secondary_id
2017-005027-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16677
Identifier Type: -
Identifier Source: org_study_id
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