AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 3SLE-BRAVE INCT03616912

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus

A Phase 3 study testing Baricitinib in people with Systemic Lupus Erythematosus, run by Eli Lilly and Company at 184 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Baricitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
830 participants
Where
184 sitesin 18 countries
Study dates
2 Aug 2018to 9 Mar 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
  • 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.
Show all 10Show fewer
  • 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)

Who cannot join

  • Have severe active lupus nephritis.
  • 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.

Trial locations and contacts

184 sites in 18 countries.

184 sites in 18 countries

United States60 sites

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico, 87102

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Piedmont Healthcare

    Atlanta, Georgia, 30318

  • Atlanta Center for Clinical Research

    Atlanta, Georgia, 30342

  • Arthritis and Rheumatic Disease

    Aventura, Florida, 33180

  • Accurate Clinical Management

    Baytown, Texas, 77521

  • East Penn Rheumatology Associates

    Bethlehem, Pennsylvania, 18015

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Rheumatology Associates of South Florida

    Boca Raton, Florida, 33486

  • St Luke's Clinic - Intermountain Orthopaedics

    Boise, Idaho, 83702

  • New England Research Associates

    Bridgeport, Connecticut, 06606

  • SUNY Health Science Center

    Brooklyn, New York, 11203

  • St. Lawrence Health System

    Canton, New York, 13617

  • Joint and Muscle Medical Care

    Charlotte, North Carolina, 28204

  • Cincinnati Arthritis Associates

    Cincinnati, Ohio, 45242

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida, 33765

  • Dr. Dhiman Basu Private Practice

    Colleyville, Texas, 76034

  • The Ohio State University

    Columbus, Ohio, 43210

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Spectrum Medical Inc.

    Danville, Virginia, 24541

  • Denver Arthritis Clinic - Lowry

    Denver, Colorado, 80230

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Precision Comprehensive Clinical Research Solutions

    Fort Worth, Texas, 76107

  • St. Joseph Heritage Medical Group

    Fullerton, California, 92835

  • Arizona Arthritis & Rheumatology Research, PLLC

    Glendale, Arizona, 85306

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Northwell Health

    Great Neck, New York, 11021

  • Medication Management, LLC

    Greensboro, North Carolina, 27408

  • MD Medical Corporation

    Hemet, California, 92543

  • Rheumatology Center of Houston

    Houston, Texas, 77004

  • Accurate Clinical Research

    Houston, Texas, 77089

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Glacier View Research Institute - Endocrinology

    Kalispell, Montana, 59901

  • The Feinstein Institute for Medical Research

    Manhasset, New York, 11030

  • Arthritis and Rheumatology Center of South Florida

    Margate, Florida, 33063

  • Southwest Rheumatology, P.A.

    Mesquite, Texas, 75150

  • Lakes Research, LLC

    Miami Lakes, Florida, 33014

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • Columbia University Medical Center

    New York, New York, 10032

  • Arthritis & Rheumatology Center of Oklahoma PLLC

    Oklahoma City, Oklahoma, 73102

  • Buffalo Rheumatology

    Orchard Park, New York, 14127

  • Millennium Research

    Ormond Beach, Florida, 32174

  • UPMC Lupus Center of Excellence

    Pittsburgh, Pennsylvania, 15213

  • IRIS Research and Development, LLC

    Plantation, Florida, 33324

  • ACRC Studies

    Poway, California, 92064

  • Allied Clinical Research

    Reno, Nevada, 89519

  • Rockford Orthopedic Associates

    Rockford, Illinois, 61114

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan, 48081

  • Accurate Clinical Research, Inc.

    San Antonio, Texas, 78229

  • Univ of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Arthritis Clinic Of Central Texas

    San Marcos, Texas, 78666

  • Office: Hans R Barthel M.D.

    Santa Barbara, California, 93108

  • Swedish Medical Center

    Seattle, Washington, 98122

  • St. Louis Rheumatology

    St Louis, Missouri, 63119

  • ForCare Clinical Research

    Tampa, Florida, 33613-1244

  • University of Arizona

    Tucson, Arizona, 85711

  • Medvin Clinical Research - Weidmann

    Whittier, California, 90602

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

China17 sites

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Peking Union Medical College Hospital

    Beijing, 100730

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 100853

  • First affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • First Affiliated Hospital of the Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Huashan Hospital Affil to Fu Dan University

    Shanghai, 200040

  • China Medical University (CMU) - First Affiliated Hospital

    Shenyang, 110001

  • The First Affliated Hospital of Soochow University

    Suzhou, China, 215000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, 830001

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Zhengzhou Universtiy

    Zhengzhou, Henan, 450000

Other trials in China

Russia16 sites

  • Chelyabinsk Regional Clinical Hospital

    Chelyabinsk, 454076

  • City Hospital # 7

    Kazan', 420103

  • Regional Clinical Hospital

    Kursk, 305007

  • Russian State Medical University

    Moscow, 117997

  • City Clinical Hospital 1 named after N.I. Pirogov

    Moscow, 119049

  • Rheumatology Institute RAMS

    Moscow

  • Healthy Family

    Novosibirsk, 630061

  • Reafan

    Novosibirsk, 630099

  • Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences

    Novosibirsk, 630117

  • Regional Hospital - Omsk

    Omsk, 644111

  • Orenburg State Medical Academy of Roszdrav

    Orenburg, 460018

  • Ryazan State Medical University

    Ryazan, 390026

  • LLC MK Med

    Saint Petersburg, Sankt-Peterburg, 197372

  • Russian Medical Military Academy n.a. S.M. Kirov

    Saint Petersburg, 194044

  • Departmental Hospital at Smolensk Station "rzhd" JSC

    Smolensk, 214025

  • Kuvatov Republican Clinical Hospital

    Ufa, 450005

Other trials in Russia

Mexico14 sites

  • Centro Integral en Reumatologia SA de CV

    Guadalajara, Jalisco, 44160

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, Jalisco, 44650

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Guadalajara, Jalisco, 44690

  • Morales Vargas Centro de Investigacion, S.C.

    León, Guanajuato, 37000

  • Centro Peninsular de Investigacion S.C.P

    Mérida, Yucatán, 97000

  • Köhler & Milstein Research

    Mérida, Yucatán, 97070

  • Cemdeicy S.C.P.

    Mérida, Yucatán, 97130

  • Cliditer Sa de CV

    Mexico City, Mexico City, 06700

  • Hospital Angeles Lindavista

    Mexico City, Mexico City, 07760

  • Clinosar Mexico S.A. de C.V

    Mexico City, 06760

  • Centro de Investigación y Tratamiento Reumatológico S.C

    Mexico City, 11850

  • Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.

    San Luis Potosí City, 78213

  • CIMAB SA de CV

    Torreón, Coahuila, 27000

  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

    Zapopan, Jalisco, 45070

Other trials in Mexico

Germany11 sites

  • Charité Universitätsmedizin Berlin Campus Buch

    Berlin, 10117

  • Immanuel Krankenhaus Rheuma Klinik Berlin Buch

    Berlin, 13125

  • Schlosspark Klinik

    Berlin, 14059

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 01307

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universität Leipzig - Universitätsklinikum

    Leipzig, Saxony, 04103

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum der Universität München

    München, Bavaria, 80336

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Würzburg A. ö. R.

    Würzburg, Bavaria, 97080

Other trials in Germany

Brazil10 sites

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • Hospital de Clinicas UNICAMP

    Campinas, São Paulo, 13083-970

  • Oncovida- Centro de Onco-Hematologia de Mato Grosso

    Cuiabá, 78043-142

  • Centro de Estudos em Terapias Inovadoras-CETI

    Curitiba, Paraná, 80030-110

  • EDUMED - Educação em Saúde Ltda.

    Curitiba, Paraná, 80440-080

  • CIP-Centro Internacional de Pesquisa

    Goiânia, Goiás, 74110-120

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-003

  • LMK Serviços Médicos S/S

    Porto Alegre, Rio Grande do Sul, 90540-000

  • SER - Serviços Especializados em Reumatologia da Bahia S/S - ME

    Salvador, Estado de Bahia, 40150-150

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-903

Other trials in Brazil

Hungary10 sites

  • Budai Irgalmasrendi Korhaz

    Budapest, 1027

  • Qualiclinic Kft

    Budapest, 1036

  • Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek

    Debrecen, 4032

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Bekes Megyei Pandy Kalman Korhaz

    Gyula, Bekes County, 5700

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7632

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika

    Szeged, 6725

  • Vita Verum Egeszsegugyi Szolgaltato Bt

    Székesfehérvár, 8000

  • Vital Medical Center

    Veszprém, Veszprém City, 8200

Other trials in Hungary

Taiwan9 sites

  • Hualien Tzu-Chi Hospital

    Dalin Township, 622

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81346

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 833401

  • Chang Gung Memorial Hospital - Linkou

    Kuei Shan Hsiang, Taoyuan Hsien, 33305

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Chi-Mei Medical Center

    Tainan, 71004

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Medical University Hospital

    Taipei, 110

Other trials in Taiwan

Australia6 sites

  • Emeritus Research

    Botany, New South Wales, 2019

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • The Rheumatology Research Unit Sunshine Coast

    Maroochydore, Queensland, 4558

  • Griffith University

    Southport, 4215

Other trials in Australia

Czechia5 sites

  • Revmatologie.s.r.o.

    Brno, 63800

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • ARTHROHELP s.r.o.

    Pardubice, 53002

  • Revmatologicky ustav

    Prague, Praha, Hlavní Mešto, 12850

  • Vseobecna fakultni nemocnice

    Prague, 128 08

Other trials in Czechia

Greece5 sites

  • Gen Hospital of Athens G Gennimatas

    Athens, Attica, 11527

  • University General Hospital of Heraklion

    Heraklion, Crete, 71110

  • University General Hospital of Larissa

    Larissa, 41110

  • Euromedica Kyanous Stavros General Hospital

    Thessaloniki, 54636

  • Hippokration University Hopsital

    Thessaloniki, 54642

Other trials in Greece

United Kingdom5 sites

  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

    Doncaster, DN2 5LT

  • Whipps Cross University Hospital

    London, Surrey, E11 1NR

  • Guy's Hospital

    London, SE1 9RT

  • St. George's University Hospitals NHS Foundation Trust

    London, SW17 0QT

  • Maidstone Hospital

    Maidstone, Kent, ME16 9QQ

Other trials in United Kingdom

Austria3 sites

  • Medizinische Universität Graz

    Graz, 8036

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Upper Austria, 4020

  • Klinik Hietzing

    Vienna, 1130

Other trials in Austria

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

  • CHU de Liège

    Liège, 4000

Other trials in Belgium

Croatia3 sites

  • Klinicki Bolnicki Centar Rijeka

    Rijeka, 51000

  • University Hospital Split

    Split, 21000

  • Clinical Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Israel3 sites

  • Carmel Hospital

    Haifa, Ḥeifā, 3436212

  • Meir Medical Center

    Kfar Saba, 4428164

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100

Other trials in Israel

Netherlands2 sites

  • Vrije Universiteit Medisch Centrum Amsterdam

    Amsterdam, 1081 HV

  • Medische Centrum Leeuwarden

    Leeuwarden, Provincie Friesland, 8934 AD

Other trials in Netherlands

Switzerland2 sites

  • Universitätsspital Basel

    Basel, Canton of Basel-City, 4031

  • Cantonal Hospital St.Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

Being tested
Baricitinib, Placebo
Keywords
SLE
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaricitinibDrug

    Also called LY3009104

    Administered orally.

  • PlaceboDrug

    Administered orally.

Study groups in NCT03616912
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Receives: Drug: Placebo
2 mg BaricitinibExperimentalParticipants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Receives: Drug: Baricitinib; Drug: Placebo
4 mg BaricitinibExperimentalParticipants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Receives: Drug: Baricitinib; Drug: Placebo
Placebo Maximum Extended Enrollment (MEE)Placebo comparatorParticipants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
Receives: Drug: Placebo
2 mg Baricitinib (MEE)ExperimentalParticipants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Receives: Drug: Baricitinib; Drug: Placebo
4 mg Baricitinib (MEE)ExperimentalParticipants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Receives: Drug: Baricitinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)

    SRI-4 response defined as 1)greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale).

    SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).

    Measured: Week 52

Secondary outcomes (11)

  1. Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib

    SRI-4 response defined as 1)greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale).

    SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).

    Measured: Week 52

  2. Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)

    The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg daily.

    Measured: Week 52

  3. Time to First Severe Flare

    Time to first severe flare was analyzed using a Cox proportional hazards model with treatment group, baseline disease activity (Systemic Lupus Erythematosus Disease Activity Index 2000 [SLEDAI-2K ] <10; SLEDAI-2K ≥10), baseline corticosteroid dose (<10 mg/day; ≥10 mg/day prednisone or equivalent), and region fitted as explanatory variables. Participants who did not have severe flare during the flare exposure time period were censored at the end of the flare exposure time.

    Measured: Baseline to Week 52

  4. Percentage of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Participants Receiving Greater Than 7.5 mg/Day at Baseline

    For the analysis of steroid use, steroid dosages were converted to a prednisone equivalent in mg. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52.

    Measured: Baseline, Week 40 through Week 52

  5. Change From Baseline in Worst Pain Numeric Rating Scale (NRS)

    Participants assessed their worst pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The average worst daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

    Measured: Baseline, Week 52

  6. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score

    FACIT-Fatigue score calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

    Measured: Baseline, Week 52

  7. Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score

    The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.

    Measured: Week 52

  8. Change From Baseline in Tender Joints Count

    The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

    Measured: Baseline, Week 52

  9. Change From Baseline in Swollen Joint Count

    The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.

    Measured: Baseline, Week 52

  10. Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)

    PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) was evaluated using population PK approach.

    Measured: Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose

  11. Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)

    Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) was evaluated using population PK approach.

    Measured: Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start2 Aug 2018
  3. Primary completion1 Nov 2021
  4. Study completion9 Mar 2022

Why it stopped: Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
830 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03616912
Sponsor's protocol ID
16676
Other IDs
I4V-MC-JAHZ, 2017-005026-37, 2017
Acronym
SLE-BRAVE I
Status last verified
Jan 2023
First submitted
1 Aug 2018
Last updated
30 Jan 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • 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.

    PubMed 40305472

  • Morand EF, Vital EM, Petri M, van Vollenhoven R, Wallace DJ, Mosca M, Furie RA, Silk ME, Dickson CL, Meszaros G, Jia B, Crowe B, de la Torre I, Dorner T. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I). Lancet. 2023 Mar 25;401(10381):1001-1010. doi: 10.1016/S0140-6736(22)02607-1. Epub 2023 Feb 24.

    PubMed 36848918

  • 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.

    PubMed 33687069

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baricitinib in people with Systemic Lupus Erythematosus, run by Eli Lilly and Company at 184 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, China, Russia, Mexico, Germany and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03616912, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in