A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE-BRAVE I)

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).

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Drug: Baricitinib

• Study Type: Interventional
• Enrollment (Actual): 830
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Southport, Australia, 4215
    • Griffith University
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Emeritus Research
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • The Rheumatology Research Unit Sunshine Coast
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Fitzroy, Victoria, Australia, 3065
      • St Vincents Hospital Melbourne
• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz
  • Wien, Austria, 1130
    • Klinik Hietzing
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4020
      • Ordensklinikum Linz GmbH Elisabethinen
• Belgium
  • Liège, Belgium, 4000
    • CHU de Liege
  • Brussel
    • Bruxelles, Brussel, Belgium, 1200
      • Cliniques universitaires Saint-Luc
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven
• Brazil
  • Cuiaba, Brazil, 78043-142
    • Oncovida- Centro de Onco-Hematologia de Mato Grosso
  • Sao Paulo, Brazil, 01323-903
    • Hospital Alemao Oswaldo Cruz
  • Bahia
    • Salvador, Bahia, Brazil, 40150-150
      • SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
  • Goiás
    • Goiania, Goiás, Brazil, 74110-120
      • CIP-Centro Internacional de Pesquisa
  • MG
    • Belo Horizonte, MG, Brazil, 30150-221
      • Santa Casa de Misericordia de Belo Horizonte
  • Paraná
    • Curitiba, Paraná, Brazil, 80030-110
      • Centro de Estudos em Terapias Inovadoras-CETI
    • Curitiba, Paraná, Brazil, 80440-080
      • EDUMED - Educação em Saúde Ltda.
  • RS
    • Porto Alegre, RS, Brazil, 90035-003
      • Hospital de Clinicas de Porto Alegre
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90540-000
      • LMK Serviços Médicos S/S
  • SP
    • Campinas, SP, Brazil, 13083-970
      • Hospital de Clinicas UNICAMP
• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100730
    • Beijing Peking Union Medical College Hospital
  • Shanghai, China, 200040
    • Shanghai Huashan Hospital Affil to Fu Dan University
  • Shenyang, China, 110001
    • China Medical University (CMU) - First Affiliated Hospital
  • Suzhou Shi, China, 215000
    • The First Affliated Hospital of Soochow University
  • Urumqi, China, 830001
    • People's Hospital of Xinjiang Uygur Autonomous Region
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • First Affiliated Hospital of Sun Yat-sen University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • First Affiliated Hospital of the Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated Hospital of Zhengzhou Universtiy
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Jiangxi
    • Pingxiang, Jiangxi, China, 337055
      • Jiangxi Pingxiang People's Hospital
  • Jilin
    • Changchun, Jilin, China, 100853
      • China-Japan Union Hospital of Jilin University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan hospital, Fudan university
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital
• Croatia
  • Rijeka, Croatia, 51000
    • Klinicki Bolnicki Centar Rijeka
  • Split, Croatia, 21000
    • University Hospital Split
  • Zagreb, Croatia, 10000
    • Clinical Hospital Dubrava
• Czechia
  • Brno, Czechia, 63800
    • Revmatologie.s.r.o.
  • Olomouc, Czechia, 775 20
    • Fakultni Nemocnice Olomouc
  • Pardubice, Czechia, 53002
    • Arthrohelp S.R.O.
  • Praha 2, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice
  • Praha, Hlavní Mešto
    • Praha 2, Praha, Hlavní Mešto, Czechia, 12850
      • Revmatologicky Ustav
• Germany
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Berlin Campus Buch
  • Berlin, Germany, 13125
    • Immanuel Krankenhaus Rheuma Klinik Berlin Buch
  • Berlin, Germany, 14059
    • Schlosspark Klinik
  • Baden-Wurttemberg
    • Tubingen, Baden-Wurttemberg, Germany, 72076
      • Universitatsklinikum Tubingen
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • Universitatsklinikum Freiburg
  • Bayern
    • München, Bayern, Germany, 80336
      • Klinikum der Universität München
    • Würzburg, Bayern, Germany, 97080
      • Universitätsklinikum Würzburg A. ö. R.
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Universitätsklinikum Köln
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitatsklinikum Carl Gustav Carus
    • Leipzig, Sachsen, Germany, 04103
      • Universität Leipzig - Universitätsklinikum
• Greece
  • Larissa, Greece, 41110
    • University General Hospital of Larissa
  • Thessaloniki, Greece, 54642
    • Hippokration University Hopsital
  • Thessaloniki, Greece, 54636
    • Euromedica Kyanous Stavros General Hospital
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Gen Hospital of Athens G Gennimatas
  • Crete
    • Heraklion, Crete, Greece, 71110
      • University General Hospital of Heraklion
• Hungary
  • Budapest, Hungary, 1027
    • Budai Irgalmasrendi Korhaz
  • Budapest, Hungary, 1036
    • Qualiclinic Kft
  • Budapest, Hungary, 1097
    • Egyesített Szent István és Szent László Kórház-Rendelőintéze
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek
  • Pecs, Hungary, 7632
    • Pécsi Tudományegyetem Klinikai Központ
  • Szeged, Hungary, 6725
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
  • Székesfehérvár, Hungary, 8000
    • Vita Verum Egeszsegugyi Szolgaltato Bt
  • Bekes
    • Gyula, Bekes, Hungary, 5700
      • Békés Megyei Pándy Kálmán Kórház
  • Veszprém City
    • Veszprem, Veszprém City, Hungary, 8200
      • Vital Medical Center
• Israel
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Ramat Gan, Israel, 5262100
    • Chaim Sheba Medical Center
  • Ḥeifā
    • Haifa, Ḥeifā, Israel, 3436212
      • Carmel Hospital
• Mexico
  • Ciudad De México, Mexico, 11850
    • Centro de Investigación y Tratamiento Reumatológico S.C
  • Mexico City, Mexico, 06760
    • Clinosar Mexico S.A. de C.V
  • San Luis Potosi, Mexico, 78213
    • Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
  • Coahuila
    • Torreon, Coahuila, Mexico, 27000
      • CIMAB SA de CV
  • DF
    • Mexico city, DF, Mexico, 07760
      • Hospital Angeles Lindavista
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 06700
      • Cliditer SA de CV
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigacion, S.C.
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Centro Integral en Reumatologia SA de CV
    • Guadalajara, Jalisco, Mexico, 44650
      • Clinica de Investigacion en Reumatologia y Obesidad S. C.
    • Guadalajara, Jalisco, Mexico, 44690
      • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
    • Zapopan, Jalisco, Mexico, 45070
      • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Köhler & Milstein Research
  • Yucatán
    • Merida, Yucatán, Mexico, 97130
      • Cemdeicy S.C.P.
    • Merida, Yucatán, Mexico, 97000
      • Centro Peninsular de Investigacion S.C.P
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Vrije Universiteit Medisch Centrum Amsterdam
  • Fryslân
    • Leeuwarden, Fryslân, Netherlands, 8934 AD
      • Medische Centrum Leeuwarden
• Russian Federation
  • Chelyabinsk, Russian Federation, 454076
    • Chelyabinsk Regional Clinical Hospital
  • Kazan, Russian Federation, 420103
    • City Hospital # 7
  • Kursk, Russian Federation, 305007
    • Regional Clinical Hospital
  • Moscow, Russian Federation, 117997
    • Russian State Medical University
  • Moscow, Russian Federation, 119049
    • City Clinical Hospital 1 named after N.I. Pirogov
  • Moscow, Russian Federation
    • Rheumatology Institute RAMS
  • Novosibirsk, Russian Federation, 630117
    • Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
  • Novosibirsk, Russian Federation, 630061
    • Healthy Family
  • Novosibirsk, Russian Federation, 630099
    • Reafan
  • Omsk, Russian Federation, 644111
    • Regional Hospital - Omsk
  • Orenburg, Russian Federation, 460018
    • Orenburg State Medical Academy of Roszdrav
  • Ryazan, Russian Federation, 390026
    • Ryazan State Medical University
  • Saint Petersburg, Russian Federation, 194044
    • Russian Medical Military Academy n.a. S.M. Kirov
  • Smolensk, Russian Federation, 214025
    • Departmental Hospital at Smolensk Station "rzhd" JSC
  • Ufa, Russian Federation, 450005
    • Kuvatov Republican Clinical Hospital
  • Saint Petersburg
    • St. Petersburg, Saint Petersburg, Russian Federation, 197372
      • LLC MK Med
• Switzerland
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4031
      • Universitätsspital Basel
  • Sankt Gallen
    • st.Gallen, Sankt Gallen, Switzerland, 9007
      • Cantonal Hospital St.Gallen
• Taiwan
  • Dalin Township, Taiwan, 622
    • Hualien Tzu-Chi Hospital
  • Kaohsiung, Taiwan, 81346
    • Kaohsiung Veterans General Hospital
  • Kaohsiung City, Taiwan, 833401
    • Chang Gung Memorial Hospital - Kaohsiung Branch
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan City, Taiwan, 71004
    • Chi-Mei Medical Center
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
  • Taoyuan Hsien
    • Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 33305
      • Chang Gung Memorial Hospital - Linkou
• United Kingdom
  • Doncaster, United Kingdom, DN2 5LT
    • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom, SW17 0QT
    • St. George's University Hospitals NHS Foundation Trust
  • Kent
    • Maidstone, Kent, United Kingdom, ME16 9QQ
      • Maidstone Hospital
  • Surrey
    • London, Surrey, United Kingdom, E11 1NR
      • Whipps Cross University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Arthritis & Rheumatology Research, PLLC
    • Tucson, Arizona, United States, 85711
      • University of Arizona
  • California
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Medical Group
    • Hemet, California, United States, 92543
      • MD Medical Corporation
    • Poway, California, United States, 92064
      • ACRC Studies
    • Santa Barbara, California, United States, 93108
      • Office: Hans R Barthel M.D.
    • Whittier, California, United States, 90602
      • Medvin Clinical Research - Weidmann
  • Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Clinic - Lowry
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • New England Research Associates
    • New Haven, Connecticut, United States, 06519
      • Yale University School Of Medicine
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis and Rheumatic Disease
    • Boca Raton, Florida, United States, 33486
      • Rheumatology Associates of South Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc. (Clearwater)
    • Margate, Florida, United States, 33063
      • Arthritis and Rheumatology Center of South Florida
    • Miami Lakes, Florida, United States, 33014
      • Lakes Research, LLC
    • Ormond Beach, Florida, United States, 32174
      • Millennium Research
    • Plantation, Florida, United States, 33324
      • IRIS Research and Development, LLC
    • Tampa, Florida, United States, 33613-1244
      • ForCare Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Piedmont Healthcare
    • Atlanta, Georgia, United States, 30342
      • Atlanta Center for Clinical Research
  • Idaho
    • Boise, Idaho, United States, 83702
      • St Luke's Clinic - Intermountain Orthopaedics
  • Illinois
    • Rockford, Illinois, United States, 61114
      • Rockford Orthopedic Associates
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Saint Clair Shores, Michigan, United States, 48081
      • Clinical Research Institute of Michigan, LLC
  • Missouri
    • Saint Louis, Missouri, United States, 63119
      • St. Louis Rheumatology
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute - Endocrinology
  • Nevada
    • Reno, Nevada, United States, 89519
      • Allied Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Center For Rheumatology
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Health Science Center
    • Canton, New York, United States, 13617
      • St. Lawrence Health System
    • Great Neck, New York, United States, 11021
      • Northwell Health
    • Manhasset, New York, United States, 11030
      • The Feinstein Institute for Medical Research
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Orchard Park, New York, United States, 14127
      • Buffalo Rheumatology
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Joint and Muscle Medical Care
    • Greensboro, North Carolina, United States, 27408
      • Medication Management, LLC
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Arthritis Associates
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Middleburg Heights, Ohio, United States, 44130
      • Paramount Medical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Arthritis & Rheumatology Center of Oklahoma PLLC
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • East Penn Rheumatology Associates
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Lupus Center of Excellence
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
  • Texas
    • Amarillo, Texas, United States, 79124
      • Amarillo Center for Clinical Research
    • Baytown, Texas, United States, 77521
      • Accurate Clinical Management
    • Colleyville, Texas, United States, 76034
      • Dr. Dhiman Basu Private Practice
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Fort Worth, Texas, United States, 76107
      • Precision Comprehensive Clinical Research Solutions
    • Houston, Texas, United States, 77089
      • Accurate Clinical Research
    • Houston, Texas, United States, 77004
      • Rheumatology Center Of Houston
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology, P.A.
    • San Antonio, Texas, United States, 78229
      • Accurate Clinical Research, Inc.
    • San Antonio, Texas, United States, 78229
      • Univ of Texas Health Science Center at San Antonio
    • San Marcos, Texas, United States, 78666
      • Arthritis Clinic of Central Texas
  • Virginia
    • Danville, Virginia, United States, 24541
      • Spectrum Medical Inc.
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
  • Wisconsin
    • Glendale, Wisconsin, United States, 53217
      • Rheumatic Disease Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

• 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.	Drug: Placebo; Administered orally.
Experimental: 2 mg Baricitinib; Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.	Drug: Placebo; Administered orally.; Drug: Baricitinib; Administered orally.; Other Names: LY3009104
Experimental: 4 mg Baricitinib; Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.	Drug: Placebo; Administered orally.; Drug: Baricitinib; Administered orally.; Other Names: LY3009104
Placebo Comparator: Placebo Maximum Extended Enrollment (MEE); Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.	Drug: Placebo; Administered orally.
Experimental: 2 mg Baricitinib (MEE); Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.	Drug: Placebo; Administered orally.; Drug: Baricitinib; Administered orally.; Other Names: LY3009104
Experimental: 4 mg Baricitinib (MEE); Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.	Drug: Placebo; Administered orally.; Drug: Baricitinib; Administered orally.; Other Names: LY3009104

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Week 52
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.	Week 52
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.	Baseline to Week 52
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.	Baseline, Week 40 through Week 52
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.	Baseline, Week 52
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.	Baseline, Week 52
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.	Week 52
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.	Baseline, Week 52
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.	Baseline, Week 52
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.	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
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.	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Incyte Corporation

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: SLE
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 16676; I4V-MC-JAHZ (Other Identifier: Eli Lilly and Company); 2017-005026-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No