A Study of Baricitinib (LY3009104) in Participants With S... | NCT03616912 | Trialant
NCT03616912
Sponsor
Eli Lilly and Company
Status
Terminated
Last Update Posted
Jan 30, 2023Actual
Enrollment
830Actual
Phase
Phase 3
Conditions
Systemic Lupus Erythematosus
Interventions
Baricitinib
Placebo
Countries
United States
Australia
Austria
Belgium
Brazil
China
Croatia
Czechia
Germany
Greece
Hungary
Israel
Mexico
Netherlands
Russia
Switzerland
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03616912
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16676
Secondary IDs
ID
Type
Description
Link
I4V-MC-JAHZ
Other Identifier
Eli Lilly and Company
2017-005026-37
EudraCT Number
Brief Title
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
Acronym
SLE-BRAVE I
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.
Expanded Access Info
No
Start Date
Aug 2, 2018Actual
Primary Completion Date
Nov 1, 2021Actual
Completion Date
Mar 9, 2022Actual
First Submitted Date
Aug 1, 2018
First Submission Date that Met QC Criteria
Aug 1, 2018
First Posted Date
Aug 6, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 11, 2022
Results First Submitted that Met QC Criteria
Jan 4, 2023
Results First Posted Date
Jan 30, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 4, 2023
Last Update Posted Date
Jan 30, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Incyte Corporation
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief 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).
Detailed Description
Not provided
Conditions Module
Conditions
Systemic Lupus Erythematosus
Keywords
SLE
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
830Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
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
2 mg Baricitinib
Experimental
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Drug: Baricitinib
Drug: Placebo
4 mg Baricitinib
Experimental
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Drug: Baricitinib
Drug: Placebo
Placebo Maximum Extended Enrollment (MEE)
Placebo Comparator
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
Drug: Placebo
2 mg Baricitinib (MEE)
Experimental
Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Baricitinib
Drug
Administered orally.
2 mg Baricitinib
2 mg Baricitinib (MEE)
4 mg Baricitinib
4 mg Baricitinib (MEE)
Outcomes Module
Primary Outcomes
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 Outcomes
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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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)
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.
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.
See Also Links
Label
URL
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
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.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
One investigational site with seven participants was excluded from analysis due to confirmed misconduct.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
2 mg Baricitinib
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 20, 2020
Jul 13, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Ukraine
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Baricitinib
Drug: Placebo
4 mg Baricitinib (MEE)
Experimental
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Drug: Baricitinib
Drug: Placebo
LY3009104
Placebo
Drug
Administered orally.
2 mg Baricitinib
2 mg Baricitinib (MEE)
4 mg Baricitinib
4 mg Baricitinib (MEE)
Placebo
Placebo Maximum Extended Enrollment (MEE)
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
Birmingham
Alabama
35294
United States
Arizona Arthritis & Rheumatology Research, PLLC
Glendale
Arizona
85306
United States
University of Arizona
Tucson
Arizona
85711
United States
St. Joseph Heritage Medical Group
Fullerton
California
92835
United States
MD Medical Corporation
Hemet
California
92543
United States
ACRC Studies
Poway
California
92064
United States
Office: Hans R Barthel M.D.
Santa Barbara
California
93108
United States
Medvin Clinical Research - Weidmann
Whittier
California
90602
United States
Denver Arthritis Clinic - Lowry
Denver
Colorado
80230
United States
New England Research Associates
Bridgeport
Connecticut
06606
United States
Yale University School of Medicine
New Haven
Connecticut
06519
United States
Arthritis and Rheumatic Disease
Aventura
Florida
33180
United States
Rheumatology Associates of South Florida
Boca Raton
Florida
33486
United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater
Florida
33765
United States
Arthritis and Rheumatology Center of South Florida
Margate
Florida
33063
United States
Lakes Research, LLC
Miami Lakes
Florida
33014
United States
Millennium Research
Ormond Beach
Florida
32174
United States
IRIS Research and Development, LLC
Plantation
Florida
33324
United States
ForCare Clinical Research
Tampa
Florida
33613-1244
United States
Piedmont Healthcare
Atlanta
Georgia
30318
United States
Atlanta Center for Clinical Research
Atlanta
Georgia
30342
United States
St Luke's Clinic - Intermountain Orthopaedics
Boise
Idaho
83702
United States
Rockford Orthopedic Associates
Rockford
Illinois
61114
United States
Henry Ford Health System
Detroit
Michigan
48202
United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores
Michigan
48081
United States
St. Louis Rheumatology
St Louis
Missouri
63119
United States
Glacier View Research Institute - Endocrinology
Kalispell
Montana
59901
United States
Allied Clinical Research
Reno
Nevada
89519
United States
Albuquerque Center for Rheumatology
Albuquerque
New Mexico
87102
United States
SUNY Health Science Center
Brooklyn
New York
11203
United States
St. Lawrence Health System
Canton
New York
13617
United States
Northwell Health
Great Neck
New York
11021
United States
The Feinstein Institute for Medical Research
Manhasset
New York
11030
United States
Columbia University Medical Center
New York
New York
10032
United States
Buffalo Rheumatology
Orchard Park
New York
14127
United States
Joint and Muscle Medical Care
Charlotte
North Carolina
28204
United States
Medication Management, LLC
Greensboro
North Carolina
27408
United States
PMG Research of Wilmington
Wilmington
North Carolina
28401
United States
Cincinnati Arthritis Associates
Cincinnati
Ohio
45242
United States
The Ohio State University
Columbus
Ohio
43210
United States
Paramount Medical Research
Middleburg Heights
Ohio
44130
United States
Arthritis & Rheumatology Center of Oklahoma PLLC
Oklahoma City
Oklahoma
73102
United States
East Penn Rheumatology Associates
Bethlehem
Pennsylvania
18015
United States
UPMC Lupus Center of Excellence
Pittsburgh
Pennsylvania
15213
United States
West Tennessee Research Institute
Jackson
Tennessee
38305
United States
Amarillo Center for Clinical Research
Amarillo
Texas
79124
United States
Accurate Clinical Management
Baytown
Texas
77521
United States
Dr. Dhiman Basu Private Practice
Colleyville
Texas
76034
United States
Metroplex Clinical Research Center
Dallas
Texas
75231
United States
Precision Comprehensive Clinical Research Solutions
Fort Worth
Texas
76107
United States
Rheumatology Center of Houston
Houston
Texas
77004
United States
Accurate Clinical Research
Houston
Texas
77089
United States
Southwest Rheumatology, P.A.
Mesquite
Texas
75150
United States
Accurate Clinical Research, Inc.
San Antonio
Texas
78229
United States
Univ of Texas Health Science Center at San Antonio
San Antonio
Texas
78229
United States
Arthritis Clinic Of Central Texas
San Marcos
Texas
78666
United States
Spectrum Medical Inc.
Danville
Virginia
24541
United States
Swedish Medical Center
Seattle
Washington
98122
United States
Rheumatic Disease Center
Glendale
Wisconsin
53217
United States
Emeritus Research
Botany
New South Wales
2019
Australia
The Rheumatology Research Unit Sunshine Coast
Maroochydore
Queensland
4558
Australia
Emeritus Research
Camberwell
Victoria
3124
Australia
Monash Medical Centre
Clayton
Victoria
3168
Australia
St Vincents Hospital Melbourne
Fitzroy
Victoria
3065
Australia
Griffith University
Southport
4215
Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz
Upper Austria
4020
Austria
Medizinische Universität Graz
Graz
8036
Austria
Klinik Hietzing
Vienna
1130
Austria
Cliniques Universitaires Saint-Luc
Brussels
Brussels Capital
1200
Belgium
UZ Leuven
Leuven
Vlaams Brabant
3000
Belgium
CHU de Liège
Liège
4000
Belgium
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador
Estado de Bahia
40150-150
Brazil
CIP-Centro Internacional de Pesquisa
Goiânia
Goiás
74110-120
Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte
Minas Gerais
30150-221
Brazil
Centro de Estudos em Terapias Inovadoras-CETI
Curitiba
Paraná
80030-110
Brazil
EDUMED - Educação em Saúde Ltda.
Curitiba
Paraná
80440-080
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre
Rio Grande do Sul
90035-003
Brazil
LMK Serviços Médicos S/S
Porto Alegre
Rio Grande do Sul
90540-000
Brazil
Hospital de Clinicas UNICAMP
Campinas
São Paulo
13083-970
Brazil
Oncovida- Centro de Onco-Hematologia de Mato Grosso
Cuiabá
78043-142
Brazil
Hospital Alemao Oswaldo Cruz
São Paulo
01323-903
Brazil
The First Affliated Hospital of Soochow University
Suzhou
China
215000
China
First affiliated Hospital of Sun Yat-Sen University
Guangzhou
Guangdong
510080
China
First Affiliated Hospital of the Harbin Medical University
Harbin
Heilongjiang
150001
China
The First Affiliated Hospital of Zhengzhou Universtiy
Zhengzhou
Henan
450000
China
Wuhan Union Hospital
Wuhan
Hubei
430022
China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing
Jiangsu
210000
China
Jiangxi Pingxiang People's Hospital
Pingxiang
Jiangxi
337055
China
China-Japan Union Hospital of Jilin University
Changchun
Jilin
100853
China
Zhongshan Hospital, Fudan University
Shanghai
Shanghai Municipality
200032
China
Tianjin Medical University General Hospital
Tianjin
Tianjin Municipality
300052
China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
310009
China
Ningbo First Hospital
Ningbo
Zhejiang
315010
China
Peking University First Hospital
Beijing
100034
China
Beijing Peking Union Medical College Hospital
Beijing
100730
China
Shanghai Huashan Hospital Affil to Fu Dan University
Shanghai
200040
China
China Medical University (CMU) - First Affiliated Hospital
Shenyang
110001
China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi
830001
China
Klinicki Bolnicki Centar Rijeka
Rijeka
51000
Croatia
University Hospital Split
Split
21000
Croatia
Clinical Hospital Dubrava
Zagreb
10000
Croatia
Revmatologicky ustav
Prague
Praha, Hlavní Mešto
12850
Czechia
Revmatologie.s.r.o.
Brno
63800
Czechia
Fakultni nemocnice Olomouc
Olomouc
775 20
Czechia
ARTHROHELP s.r.o.
Pardubice
53002
Czechia
Vseobecna fakultni nemocnice
Prague
128 08
Czechia
Universitätsklinikum Freiburg
Freiburg im Breisgau
Baden-Wurttemberg
79106
Germany
Universitätsklinikum Tübingen
Tübingen
Baden-Wurttemberg
72076
Germany
Klinikum der Universität München
München
Bavaria
80336
Germany
Universitätsklinikum Würzburg A. ö. R.
Würzburg
Bavaria
97080
Germany
Universitätsklinikum Köln
Cologne
North Rhine-Westphalia
50937
Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz
Rhineland-Palatinate
55131
Germany
Universitätsklinikum Carl Gustav Carus
Dresden
Saxony
01307
Germany
Universität Leipzig - Universitätsklinikum
Leipzig
Saxony
04103
Germany
Charité Universitätsmedizin Berlin Campus Buch
Berlin
10117
Germany
Immanuel Krankenhaus Rheuma Klinik Berlin Buch
Berlin
13125
Germany
Schlosspark Klinik
Berlin
14059
Germany
Gen Hospital of Athens G Gennimatas
Athens
Attica
11527
Greece
University General Hospital of Heraklion
Heraklion
Crete
71110
Greece
University General Hospital of Larissa
Larissa
41110
Greece
Euromedica Kyanous Stavros General Hospital
Thessaloniki
54636
Greece
Hippokration University Hopsital
Thessaloniki
54642
Greece
Bekes Megyei Pandy Kalman Korhaz
Gyula
Bekes County
5700
Hungary
Vital Medical Center
Veszprém
Veszprém City
8200
Hungary
Budai Irgalmasrendi Korhaz
Budapest
1027
Hungary
Qualiclinic Kft
Budapest
1036
Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze
Budapest
1097
Hungary
Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek
Debrecen
4032
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen
4032
Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs
7632
Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
Szeged
6725
Hungary
Vita Verum Egeszsegugyi Szolgaltato Bt
Székesfehérvár
8000
Hungary
Meir Medical Center
Kfar Saba
4428164
Israel
Chaim Sheba Medical Center
Ramat Gan
5262100
Israel
Carmel Hospital
Haifa
Ḥeifā
3436212
Israel
CIMAB SA de CV
Torreón
Coahuila
27000
Mexico
Morales Vargas Centro de Investigacion, S.C.
León
Guanajuato
37000
Mexico
Centro Integral en Reumatologia SA de CV
Guadalajara
Jalisco
44160
Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara
Jalisco
44650
Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Guadalajara
Jalisco
44690
Mexico
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan
Jalisco
45070
Mexico
Cliditer Sa de CV
Mexico City
Mexico City
06700
Mexico
Hospital Angeles Lindavista
Mexico City
Mexico City
07760
Mexico
Centro Peninsular de Investigacion S.C.P
Mérida
Yucatán
97000
Mexico
Köhler & Milstein Research
Mérida
Yucatán
97070
Mexico
Cemdeicy S.C.P.
Mérida
Yucatán
97130
Mexico
Clinosar Mexico S.A. de C.V
Mexico City
06760
Mexico
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City
11850
Mexico
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
San Luis Potosí City
78213
Mexico
Medische Centrum Leeuwarden
Leeuwarden
Provincie Friesland
8934 AD
Netherlands
Vrije Universiteit Medisch Centrum Amsterdam
Amsterdam
1081 HV
Netherlands
LLC MK Med
Saint Petersburg
Sankt-Peterburg
197372
Russia
Chelyabinsk Regional Clinical Hospital
Chelyabinsk
454076
Russia
City Hospital # 7
Kazan'
420103
Russia
Regional Clinical Hospital
Kursk
305007
Russia
Russian State Medical University
Moscow
117997
Russia
City Clinical Hospital 1 named after N.I. Pirogov
Moscow
119049
Russia
Rheumatology Institute RAMS
Moscow
Russia
Healthy Family
Novosibirsk
630061
Russia
Reafan
Novosibirsk
630099
Russia
Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
Novosibirsk
630117
Russia
Regional Hospital - Omsk
Omsk
644111
Russia
Orenburg State Medical Academy of Roszdrav
Orenburg
460018
Russia
Ryazan State Medical University
Ryazan
390026
Russia
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg
194044
Russia
Departmental Hospital at Smolensk Station "rzhd" JSC
Smolensk
214025
Russia
Kuvatov Republican Clinical Hospital
Ufa
450005
Russia
Universitätsspital Basel
Basel
Canton of Basel-City
4031
Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen
Canton of St. Gallen
9007
Switzerland
Chang Gung Memorial Hospital - Linkou
Kuei Shan Hsiang
Taoyuan Hsien
33305
Taiwan
Hualien Tzu-Chi Hospital
Dalin Township
622
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City
81346
Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City
833401
Taiwan
China Medical University Hospital
Taichung
40447
Taiwan
Taichung Veterans General Hospital
Taichung
40705
Taiwan
Chi-Mei Medical Center
Tainan
71004
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
Taipei Medical University Hospital
Taipei
110
Taiwan
Maidstone Hospital
Maidstone
Kent
ME16 9QQ
United Kingdom
Whipps Cross University Hospital
London
Surrey
E11 1NR
United Kingdom
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster
DN2 5LT
United Kingdom
Guy's Hospital
London
SE1 9RT
United Kingdom
St. George's University Hospitals NHS Foundation Trust
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.
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered orally QD for 52 weeks.
FG002
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
FG003
Placebo (MEE)
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
FG004
2 mg Baricitinib (MEE)
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
FG005
4 mg Baricitinib (MEE)
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
FG000257 subjects
FG001258 subjects
FG002254 subjects
FG00321 subjects
FG00420 subjects
FG00520 subjects
Received at Least One Dose of Study Drug
FG000257 subjects
FG001256 subjects
FG002254 subjects
FG00321 subjects
FG00420 subjects
FG00520 subjects
Excluded Due to Site Misconduct
FG0004 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG000204 subjects
FG001211 subjects
FG002208 subjects
FG0035 subjects
FG0045 subjects
FG0056 subjects
NOT COMPLETED
FG00053 subjects
FG00147 subjects
FG00246 subjects
FG00316 subjects
FG00415 subjects
FG00514 subjects
Type
Comment
Reasons
Adverse Event
FG00017 subjects
FG00121 subjects
FG0029 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Death
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG00013 subjects
FG0016 subjects
FG0028 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG004
Due to Epidemic/Pandemic
FG0004 subjects
FG0012 subjects
FG0025 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00012 subjects
FG00112 subjects
FG00215 subjects
FG0032 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00310 subjects
FG004
Protocol Deviation
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Physician Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized But Never Treated
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
All randomized participants who receive at least one dose of study drug. One investigational site with seven participants was excluded from analysis due to confirmed misconduct.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
BG001
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
BG002
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
BG003
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.
BG004
2 mg Baricitinib MEE
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
BG005
4 mg Baricitinib MEE
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000253
BG001255
BG002252
BG00321
BG00420
BG00520
BG006821
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.00± 11.98
BG00142.90± 12.44
BG00241.50± 12.88
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG000237
BG001238
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG00113
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00012
BG00115
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Australia
Title
Measurements
BG00010
BG0019
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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).
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (Modified intent to treat (mITT population). Missing data was imputed using the hybrid imputation method [nonresponder imputation (NRI) + multiple imputation (MI)]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
OG001
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
OG000253
OG001252
Title
Denominators
Categories
Title
Measurements
OG00045.9
OG00156.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.016
Odds Ratio (OR)
1.57
2-Sided
95
1.09
2.27
Superiority
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).
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). Missing data was imputed using the hybrid imputation method [nonresponder imputation (NRI) + multiple imputation (MI)]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
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.
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). Missing data was imputed using the hybrid imputation method [nonresponder imputation (NRI) + multiple imputation (MI)]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
OG001
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
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.
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Median
95% Confidence Interval
weeks
Baseline to Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
OG001
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
OG002
4 mg Baricitinib
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.
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and received >7.5 mg prednisone at baseline. Missing data was imputed using the hybrid imputation method [NRI + modified last observation carried forward]. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
Baseline, Week 40 through Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
OG001
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
OG002
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.
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. Missing data was imputed using the hybrid imputation method (NRI + MMRM). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
OG001
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.
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time-point. Missing data was imputed using the hybrid imputation method (NRI + MMRM). As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally every day QD for 52 weeks.
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.
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline CLASI score of >= 10. Missing data was imputed using NRI method. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally every day QD for 52 weeks.
OG001
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
OG002
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.
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at specified time point. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
tender joint count
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally every day QD for 52 weeks.
OG001
2 mg Baricitinib
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.
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug (mITT population) and had baseline and post-baseline values at the specified time point. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
swollen joint count
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally every day QD for 52 weeks.
OG001
2 mg Baricitinib
Secondary
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.
All randomized participants who received at least one dose of study drug and had evaluable PK data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*nanograms per milliliter (h*ng/mL)
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
ID
Title
Description
OG000
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
OG001
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
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.
All randomized participants who received at least one dose of study drug and had evaluable PK data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
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
ID
Title
Description
OG000
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
OG001
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
Time Frame
Baseline through Follow-up (Up to 56 Weeks)
Description
All randomized participants, excluding participants from site with confirmed misconduct, who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
1
253
19
253
129
253
EG001
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
1
255
27
255
144
255
EG002
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
0
252
31
252
144
252
EG003
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
0
21
1
21
17
21
EG004
2 mg Baricitinib (MEE)
Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
0
20
4
20
14
20
EG005
4 mg Baricitinib (MEE)
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
0
20
3
20
17
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG0030 events0 affected21 at risk
EG0040 events0 affected20 at risk
EG0050 events0 affected20 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Abdominal adhesions
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Epiploic appendagitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Death
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Covid-19
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0015 events4 affected255 at risk
EG0022 events2 affected252 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Tubo-ovarian abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected237 at risk
EG0011 events1 affected238 at risk
EG0020 events0 affected237 at risk
EG003
Viral myocarditis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Viral pericarditis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0022 events2 affected252 at risk
EG003
Device use issue
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0022 events1 affected252 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0011 events1 affected255 at risk
EG0024 events4 affected252 at risk
EG003
Adenocarcinoma of the cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected237 at risk
EG0010 events0 affected238 at risk
EG0020 events0 affected237 at risk
EG003
Burkitt's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Haemangioma of liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Lung carcinoma cell type unspecified stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected237 at risk
EG0010 events0 affected238 at risk
EG0021 events1 affected237 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected237 at risk
EG0010 events0 affected238 at risk
EG0021 events1 affected237 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Lupus nephritis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0012 events2 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Adnexal torsion
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected237 at risk
EG0010 events0 affected238 at risk
EG0021 events1 affected237 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected237 at risk
EG0010 events0 affected238 at risk
EG0021 events1 affected237 at risk
EG003
Hydrosalpinx
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected237 at risk
EG0011 events1 affected238 at risk
EG0020 events0 affected237 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected237 at risk
EG0010 events0 affected238 at risk
EG0020 events0 affected237 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Cutaneous lupus erythematosus
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected253 at risk
EG0016 events4 affected255 at risk
EG00216 events13 affected252 at risk
EG0034 events3 affected21 at risk
EG0042 events2 affected20 at risk
EG0052 events2 affected20 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0014 events4 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG00013 events10 affected253 at risk
EG00114 events11 affected255 at risk
EG00210 events9 affected252 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0011 events1 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0012 events2 affected255 at risk
EG0024 events3 affected252 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00012 events10 affected253 at risk
EG00112 events10 affected255 at risk
EG00212 events10 affected252 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0014 events4 affected255 at risk
EG0022 events2 affected252 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0012 events2 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected253 at risk
EG00113 events11 affected255 at risk
EG00214 events12 affected252 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0015 events5 affected255 at risk
EG0023 events3 affected252 at risk
EG003
Chest discomfort
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0010 events0 affected255 at risk
EG0024 events4 affected252 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0013 events3 affected255 at risk
EG0020 events0 affected252 at risk
EG003
Covid-19
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0009 events9 affected253 at risk
EG00116 events16 affected255 at risk
EG00213 events13 affected252 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0021 events1 affected252 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0008 events8 affected253 at risk
EG0019 events9 affected255 at risk
EG00218 events16 affected252 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00024 events17 affected253 at risk
EG00121 events19 affected255 at risk
EG00224 events18 affected252 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00019 events17 affected253 at risk
EG00130 events21 affected255 at risk
EG00227 events19 affected252 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG00038 events25 affected253 at risk
EG00141 events32 affected255 at risk
EG00247 events37 affected252 at risk
EG003
Vulvitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected237 at risk
EG0010 events0 affected238 at risk
EG0020 events0 affected237 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected253 at risk
EG0018 events6 affected255 at risk
EG0025 events2 affected252 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0004 events3 affected253 at risk
EG0019 events8 affected255 at risk
EG00220 events14 affected252 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0010 events0 affected255 at risk
EG0022 events2 affected252 at risk
EG003
Weight increased
Investigations
MedDRA 24.0
Systematic Assessment
EG0009 events7 affected253 at risk
EG0015 events5 affected255 at risk
EG0023 events3 affected252 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected253 at risk
EG0012 events2 affected255 at risk
EG0026 events6 affected252 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0005 events4 affected253 at risk
EG0019 events9 affected255 at risk
EG0023 events3 affected252 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0002 events1 affected253 at risk
EG0012 events2 affected255 at risk
EG0022 events2 affected252 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0004 events4 affected253 at risk
EG0011 events1 affected255 at risk
EG0026 events5 affected252 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG00026 events25 affected253 at risk
EG00119 events16 affected255 at risk
EG00223 events20 affected252 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected253 at risk
EG0011 events1 affected255 at risk
EG0022 events2 affected252 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0008 events8 affected253 at risk
EG0014 events4 affected255 at risk
EG0026 events5 affected252 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected15 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0007 events7 affected253 at risk
EG0015 events5 affected255 at risk
EG0027 events7 affected252 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected253 at risk
EG0013 events3 affected255 at risk
EG0024 events4 affected252 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG00010 events10 affected253 at risk
EG00118 events17 affected255 at risk
EG00218 events17 affected252 at risk
EG003
One investigational site with seven participants was excluded from analysis due to confirmed misconduct.
Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Units
Counts
Participants
OG000253
OG001255
Title
Denominators
Categories
Title
Measurements
OG00045.9
OG00149.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.470
Odds Ratio (OR)
1.14
2-Sided
95
0.79
1.65
Superiority
OG002
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
OG000253
OG001255
OG002252
Title
Denominators
Categories
Title
Measurements
OG00026.2
OG00125.7
OG00229.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.839
Odds Ratio (OR)
0.96
2-Sided
95
0.63
1.45
Superiority
OG000
OG002
Regression, Logistic
0.391
Odds Ratio (OR)
1.19
2-Sided
95
0.80
1.79
Superiority
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
OG000253
OG001255
OG002252
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data not available (NA) as \< 50% of participants experienced first flare, median was not reached and 95% confidence interval could not be calculated.
OG001NA(NA to NA)Data not available (NA) as \< 50% of participants experienced first flare, median was not reached and 95% confidence interval could not be calculated.
OG002NA(NA to NA)Data not available (NA) as \< 50% of participants experienced first flare, median was not reached and 95% confidence interval could not be calculated.
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
OG000117
OG001106
OG002106
Title
Denominators
Categories
Title
Measurements
OG00030.8
OG00129.2
OG00234.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.820
Odds Ratio (OR)
0.94
2-Sided
95
0.53
1.66
Superiority
OG000
OG002
Regression, Logistic
0.565
Odds Ratio (OR)
1.18
2-Sided
95
0.67
2.08
Superiority
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
OG002
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
OG000173
OG001173
OG002182
Title
Denominators
Categories
Title
Measurements
OG000-1.62± 0.15
OG001-1.73± 0.15
OG002-1.71± 0.15
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.598
LS Mean Difference Final Values
-0.11
Standard Error of the Mean
0.21
2-Sided
95
-0.52
0.30
Superiority
OG000
OG002
Mixed Models Analysis
0.674
LS Mean Difference Final Values
-0.09
Standard Error of the Mean
0.21
2-Sided
95
-0.50
0.32
Superiority
OG001
2 mg Baricitinib
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
OG002
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
OG000188
OG001201
OG002204
Title
Denominators
Categories
Title
Measurements
OG0007.44± 0.62
OG0017.46± 0.60
OG0027.08± 0.61
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.979
LS Mean Difference Final Values
0.02
Standard Error of the Mean
0.85
2-Sided
95
-1.65
1.70
Superiority
OG000
OG002
Mixed Models Analysis
0.678
LS Mean Difference Final Values
-0.36
Standard Error of the Mean
0.86
2-Sided
95
-2.03
1.32
Superiority
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
OG00049
OG00146
OG00243
Title
Denominators
Categories
Title
Measurements
OG00049.0
OG00154.3
OG00255.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.965
Odds Ratio (OR)
1.02
2-Sided
95
0.43
2.42
Superiority
OG000
OG002
Regression, Logistic
0.661
Odds Ratio (OR)
1.22
2-Sided
95
0.51
2.92
Superiority
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
OG002
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.
Units
Counts
Participants
OG000183
OG001198
OG002195
Title
Denominators
Categories
Title
Measurements
OG000-7.50± 0.312
OG001-7.26± 0.305
OG002-7.94± 0.307
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.578
LS Mean Difference Final Values
0.24
Standard Error of the Mean
0.430
2-Sided
95
-0.61
1.08
Superiority
OG000
OG002
Mixed Models Analysis
0.309
LS Mean Difference Final Values
-0.44
Standard Error of the Mean
0.433
2-Sided
95
-1.29
0.41
Superiority
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
OG002
4 mg Baricitinib
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally QD for 52 weeks.