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

Systemic Lupus Erythematosus Clinical Trial

— SLE-BRAVE I  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03616912
• Other study ID #: 16676
• Secondary ID: I4V-MC-JAHZ2017-
• Status: Terminated
• Phase: Phase 3
• Start date: August 2, 2018
• Est. completion date: March 9, 2022

Study information

• Verified date: January 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 830
• Est. completion date: March 9, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Baricitinib
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Australia	Emeritus Research	Botany	New South Wales
Australia	Emeritus Research	Camberwell	Victoria
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St Vincents Hospital Melbourne	Fitzroy	Victoria
Australia	The Rheumatology Research Unit Sunshine Coast	Maroochydore	Queensland
Australia	Griffith University	Southport
Austria	Medizinische Universität Graz	Graz
Austria	Ordensklinikum Linz GmbH Elisabethinen	Linz	Oberösterreich
Austria	Klinik Hietzing	Wien
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles	Brussel
Belgium	UZ Leuven	Leuven	Vlaams Brabant
Belgium	CHU de Liège	Liège
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte	MG
Brazil	Hospital de Clinicas UNICAMP	Campinas	SP
Brazil	Oncovida- Centro de Onco-Hematologia de Mato Grosso	Cuiaba
Brazil	Centro de Estudos em Terapias Inovadoras-CETI	Curitiba	Paraná
Brazil	EDUMED - Educação em Saúde Ltda.	Curitiba	Paraná
Brazil	CIP-Centro Internacional de Pesquisa	Goiania	Goiás
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS
Brazil	LMK Serviços Médicos S/S	Porto Alegre	Rio Grande Do Sul
Brazil	SER - Serviços Especializados em Reumatologia da Bahia S/S - ME	Salvador	Bahia
Brazil	Hospital Alemao Oswaldo Cruz	Sao Paulo
China	Beijing Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	First affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	First Affiliated Hospital of the Harbin Medical University	Harbin	Heilongjiang
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Shanghai Huashan Hospital Affil to Fu Dan University	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	China Medical University (CMU) - First Affiliated Hospital	Shenyang
China	The First Affliated Hospital of Soochow University	Suzhou Shi
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi
China	Wuhan Union Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Zhengzhou Universtiy	Zhengzhou	Henan
Croatia	Klinicki Bolnicki Centar Rijeka	Rijeka
Croatia	University Hospital Split	Split
Croatia	Clinical Hospital Dubrava	Zagreb
Czechia	Revmatologie.s.r.o.	Brno
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	ARTHROHELP s.r.o.	Pardubice
Czechia	Revmatologicky ustav	Praha 2	Praha, Hlavní Mešto
Czechia	Vseobecna fakultni nemocnice	Praha 2
Germany	Charité Universitätsmedizin Berlin Campus Buch	Berlin
Germany	Immanuel Krankenhaus Rheuma Klinik Berlin Buch	Berlin
Germany	Schlosspark Klinik	Berlin
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Universitätsklinikum Freiburg	Freiburg	Baden-Württemberg
Germany	Universitätsklinikum Köln	Köln	Nordrhein-Westfalen
Germany	Universität Leipzig - Universitätsklinikum	Leipzig	Sachsen
Germany	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz	Mainz	Rheinland-Pfalz
Germany	Klinikum der Universität München	München	Bayern
Germany	Universitätsklinikum Tübingen	Tubingen	Baden-Wurttemberg
Germany	Universitätsklinikum Würzburg A. ö. R.	Würzburg	Bayern
Greece	Gen Hospital of Athens G Gennimatas	Athens	Attiki
Greece	University General Hospital of Heraklion	Heraklion	Crete
Greece	University General Hospital of Larissa	Larissa
Greece	Euromedica Kyanous Stavros General Hospital	Thessaloniki
Greece	Hippokration University Hopsital	Thessaloniki
Hungary	Budai Irgalmasrendi Korhaz	Budapest
Hungary	Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze	Budapest
Hungary	Qualiclinic Kft	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek	Debrecen
Hungary	Bekes Megyei Pandy Kalman Korhaz	Gyula	Bekes
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika	Szeged
Hungary	Vita Verum Egeszsegugyi Szolgaltato Bt	Székesfehérvár
Hungary	Vital Medical Center	Veszprem	Veszprém City
Israel	Carmel Hospital	Haifa	?eifa
Israel	Meir Medical Center	Kfar Saba
Israel	Chaim Sheba Medical Center	Ramat Gan
Mexico	Centro de Investigación y Tratamiento Reumatológico S.C	Ciudad De México
Mexico	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares	Guadalajara	Jalisco
Mexico	Centro Integral en Reumatologia SA de CV	Guadalajara	Jalisco
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S. C.	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion, S.C.	Leon	Guanajuato
Mexico	Cemdeicy S.C.P.	Merida	Yucatán
Mexico	Centro Peninsular de Investigacion S.C.P	Merida	Yucatán
Mexico	Köhler & Milstein Research	Merida	Yucatan
Mexico	Cliditer Sa de CV	Mexico City	Distrito Federal
Mexico	Clinosar Mexico S.A. de C.V	Mexico City
Mexico	Hospital Angeles Lindavista	Mexico city	DF
Mexico	Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.	San Luis Potosi
Mexico	CIMAB SA de CV	Torreon	Coahuila
Mexico	Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.	Zapopan	Jalisco
Netherlands	Vrije Universiteit Medisch Centrum Amsterdam	Amsterdam
Netherlands	Medische Centrum Leeuwarden	Leeuwarden	Fryslân
Russian Federation	Chelyabinsk Regional Clinical Hospital	Chelyabinsk
Russian Federation	City Hospital # 7	Kazan
Russian Federation	Regional Clinical Hospital	Kursk
Russian Federation	City Clinical Hospital 1 named after N.I. Pirogov	Moscow
Russian Federation	Rheumatology Institute RAMS	Moscow
Russian Federation	Russian State Medical University	Moscow
Russian Federation	Healthy Family	Novosibirsk
Russian Federation	Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences	Novosibirsk
Russian Federation	Reafan	Novosibirsk
Russian Federation	Regional Hospital - Omsk	Omsk
Russian Federation	Orenburg State Medical Academy of Roszdrav	Orenburg
Russian Federation	Ryazan State Medical University	Ryazan
Russian Federation	Russian Medical Military Academy n.a. S.M. Kirov	Saint Petersburg
Russian Federation	Departmental Hospital at Smolensk Station "rzhd" JSC	Smolensk
Russian Federation	LLC MK Med	St. Petersburg	Saint Petersburg
Russian Federation	Kuvatov Republican Clinical Hospital	Ufa
Switzerland	Universitätsspital Basel	Basel	Basel Stadt
Switzerland	Cantonal Hospital St.Gallen	st.Gallen	Sankt Gallen
Taiwan	Hualien Tzu-Chi Hospital	Dalin Township
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital - Kaohsiung Branch	Kaohsiung City
Taiwan	Chang Gung Memorial Hospital - Linkou	Kuei Shan Hsiang	Taoyuan Hsien
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi-Mei Medical Center	Tainan City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University Hospital	Taipei
United Kingdom	Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust	Doncaster
United Kingdom	Guy's Hospital	London
United Kingdom	St. George's University Hospitals NHS Foundation Trust	London
United Kingdom	Whipps Cross University Hospital	London	Surrey
United Kingdom	Maidstone Hospital	Maidstone	Kent
United States	Albuquerque Center for Rheumatology	Albuquerque	New Mexico
United States	Amarillo Center for Clinical Research	Amarillo	Texas
United States	Atlanta Center for Clinical Research	Atlanta	Georgia
United States	Piedmont Healthcare	Atlanta	Georgia
United States	Arthritis and Rheumatic Disease	Aventura	Florida
United States	Accurate Clinical Management	Baytown	Texas
United States	East Penn Rheumatology Associates	Bethlehem	Pennsylvania
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Rheumatology Associates of South Florida	Boca Raton	Florida
United States	St Luke's Clinic - Intermountain Orthopaedics	Boise	Idaho
United States	New England Research Associates	Bridgeport	Connecticut
United States	SUNY Health Science Center	Brooklyn	New York
United States	St. Lawrence Health System	Canton	New York
United States	Joint and Muscle Medical Care	Charlotte	North Carolina
United States	Cincinnati Arthritis Associates	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	Dr. Dhiman Basu Private Practice	Colleyville	Texas
United States	The Ohio State University	Columbus	Ohio
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Spectrum Medical Inc.	Danville	Virginia
United States	Denver Arthritis Clinic - Lowry	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Precision Comprehensive Clinical Research Solutions	Fort Worth	Texas
United States	St. Joseph Heritage Medical Group	Fullerton	California
United States	Arizona Arthritis & Rheumatology Research, PLLC	Glendale	Arizona
United States	Rheumatic Disease Center	Glendale	Wisconsin
United States	Northwell Health	Great Neck	New York
United States	Medication Management, LLC	Greensboro	North Carolina
United States	MD Medical Corporation	Hemet	California
United States	Accurate Clinical Research	Houston	Texas
United States	Rheumatology Center of Houston	Houston	Texas
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Glacier View Research Institute - Endocrinology	Kalispell	Montana
United States	The Feinstein Institute for Medical Research	Manhasset	New York
United States	Arthritis and Rheumatology Center of South Florida	Margate	Florida
United States	Southwest Rheumatology, P.A.	Mesquite	Texas
United States	Lakes Research, LLC	Miami Lakes	Florida
United States	Paramount Medical Research	Middleburg Heights	Ohio
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Arthritis & Rheumatology Center of Oklahoma PLLC	Oklahoma City	Oklahoma
United States	Buffalo Rheumatology	Orchard Park	New York
United States	Millennium Research	Ormond Beach	Florida
United States	UPMC Lupus Center of Excellence	Pittsburgh	Pennsylvania
United States	IRIS Research and Development, LLC	Plantation	Florida
United States	ACRC Studies	Poway	California
United States	Allied Clinical Research	Reno	Nevada
United States	Rockford Orthopedic Associates	Rockford	Illinois
United States	Clinical Research Institute of Michigan, LLC	Saint Clair Shores	Michigan
United States	St. Louis Rheumatology	Saint Louis	Missouri
United States	Accurate Clinical Research, Inc.	San Antonio	Texas
United States	Univ of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Arthritis Clinic Of Central Texas	San Marcos	Texas
United States	Office: Hans R Barthel M.D.	Santa Barbara	California
United States	Swedish Medical Center	Seattle	Washington
United States	ForCare Clinical Research	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	Medvin Clinical Research - Weidmann	Whittier	California
United States	PMG Research of Wilmington	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  China,  Croatia,  Czechia,  Germany,  Greece,  Hungary,  Israel,  Mexico,  Netherlands,  Russian Federation,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCt, ss)	PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCt, 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
Secondary	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

External Links

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