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

Primary Purpose

Systemic Lupus Erythematosus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baricitinib
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Achieve Clinical Research, LLC
  • University of Alabama at Birmingham
  • Arizona Arthritis & Rheumatology Research, PLLC
  • University of Arizona
  • St. Joseph Heritage Medical Group
  • MD Medical Corporation
  • ACRC Studies
  • Office: Hans R Barthel M.D.
  • Medvin Clinical Research - Weidmann
  • Denver Arthritis Clinic - Lowry
  • New England Research Associates
  • Yale University School of Medicine
  • Arthritis and Rheumatic Disease
  • Rheumatology Associates of South Florida
  • Clinical Research of West Florida, Inc. (Clearwater)
  • Arthritis and Rheumatology Center of South Florida
  • Lakes Research, LLC
  • Millennium Research
  • IRIS Research and Development, LLC
  • ForCare Clinical Research
  • Piedmont Healthcare
  • Atlanta Center for Clinical Research
  • St Luke's Clinic - Intermountain Orthopaedics
  • Rockford Orthopedic Associates
  • Henry Ford Health System
  • Clinical Research Institute of Michigan, LLC
  • St. Louis Rheumatology
  • Glacier View Research Institute - Endocrinology
  • Allied Clinical Research
  • Albuquerque Center for Rheumatology
  • SUNY Health Science Center
  • St. Lawrence Health System
  • Northwell Health
  • The Feinstein Institute for Medical Research
  • Columbia University Medical Center
  • Buffalo Rheumatology
  • Joint and Muscle Medical Care
  • Medication Management, LLC
  • PMG Research of Wilmington
  • Cincinnati Arthritis Associates
  • The Ohio State University
  • Paramount Medical Research
  • Arthritis & Rheumatology Center of Oklahoma PLLC
  • East Penn Rheumatology Associates
  • UPMC Lupus Center of Excellence
  • West Tennessee Research Institute
  • Amarillo Center for Clinical Research
  • Accurate Clinical Management
  • Dr. Dhiman Basu Private Practice
  • Metroplex Clinical Research Center
  • Precision Comprehensive Clinical Research Solutions
  • Rheumatology Center of Houston
  • Accurate Clinical Research
  • Southwest Rheumatology, P.A.
  • Accurate Clinical Research, Inc.
  • Univ of Texas Health Science Center at San Antonio
  • Arthritis Clinic Of Central Texas
  • Spectrum Medical Inc.
  • Swedish Medical Center
  • Rheumatic Disease Center
  • Emeritus Research
  • The Rheumatology Research Unit Sunshine Coast
  • Emeritus Research
  • Monash Medical Centre
  • St Vincents Hospital Melbourne
  • Griffith University
  • Ordensklinikum Linz GmbH Elisabethinen
  • Medizinische Universität Graz
  • Klinik Hietzing
  • Cliniques Universitaires Saint-Luc
  • UZ Leuven
  • CHU de Liège
  • SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
  • CIP-Centro Internacional de Pesquisa
  • Santa Casa de Misericordia de Belo Horizonte
  • Centro de Estudos em Terapias Inovadoras-CETI
  • EDUMED - Educação em Saúde Ltda.
  • LMK Serviços Médicos S/S
  • Hospital de Clinicas de Porto Alegre
  • Hospital de Clinicas UNICAMP
  • Oncovida- Centro de Onco-Hematologia de Mato Grosso
  • Hospital Alemao Oswaldo Cruz
  • First affiliated Hospital of Sun Yat-Sen University
  • First Affiliated Hospital of the Harbin Medical University
  • The First Affiliated Hospital of Zhengzhou Universtiy
  • Wuhan Union Hospital
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Jiangxi Pingxiang People's Hospital
  • China-Japan Union Hospital of Jilin University
  • Zhongshan Hospital, Fudan University
  • Tianjin Medical University General Hospital
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Ningbo First Hospital
  • Peking University First Hospital
  • Beijing Peking Union Medical College Hospital
  • Shanghai Huashan Hospital Affil to Fu Dan University
  • China Medical University (CMU) - First Affiliated Hospital
  • The First Affliated Hospital of Soochow University
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Klinicki Bolnicki Centar Rijeka
  • University Hospital Split
  • Clinical Hospital Dubrava
  • Revmatologicky ustav
  • Revmatologie.s.r.o.
  • Fakultni nemocnice Olomouc
  • ARTHROHELP s.r.o.
  • Vseobecna fakultni nemocnice
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Freiburg
  • Klinikum der Universität München
  • Universitätsklinikum Würzburg A. ö. R.
  • Universitätsklinikum Köln
  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
  • Universitätsklinikum Carl Gustav Carus
  • Universität Leipzig - Universitätsklinikum
  • Charité Universitätsmedizin Berlin Campus Buch
  • Immanuel Krankenhaus Rheuma Klinik Berlin Buch
  • Schlosspark Klinik
  • Gen Hospital of Athens G Gennimatas
  • University General Hospital of Heraklion
  • University General Hospital of Larissa
  • Euromedica Kyanous Stavros General Hospital
  • Hippokration University Hopsital
  • Bekes Megyei Pandy Kalman Korhaz
  • Vital Medical Center
  • Budai Irgalmasrendi Korhaz
  • Qualiclinic Kft
  • Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze
  • Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek
  • Debreceni Egyetem Klinikai Kozpont
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
  • Vita Verum Egeszsegugyi Szolgaltato Bt
  • Meir Medical Center
  • Chaim Sheba Medical Center
  • Carmel Hospital
  • CIMAB SA de CV
  • Hospital Angeles Lindavista
  • Cliditer Sa de CV
  • Morales Vargas Centro de Investigacion, S.C.
  • Centro Integral en Reumatologia SA de CV
  • Clinica de Investigacion en Reumatologia y Obesidad S. C.
  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
  • Köhler & Milstein Research
  • Centro Peninsular de Investigacion S.C.P
  • Cemdeicy S.C.P.
  • Centro de Investigación y Tratamiento Reumatológico S.C
  • Clinosar Mexico S.A. de C.V
  • Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
  • Medische Centrum Leeuwarden
  • Vrije Universiteit Medisch Centrum Amsterdam
  • LLC MK Med
  • Chelyabinsk Regional Clinical Hospital
  • City Hospital # 7
  • Regional Clinical Hospital
  • Russian State Medical University
  • City Clinical Hospital 1 named after N.I. Pirogov
  • Rheumatology Institute RAMS
  • Healthy Family
  • Reafan
  • Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
  • Regional Hospital - Omsk
  • Orenburg State Medical Academy of Roszdrav
  • Ryazan State Medical University
  • Russian Medical Military Academy n.a. S.M. Kirov
  • Departmental Hospital at Smolensk Station "rzhd" JSC
  • Kuvatov Republican Clinical Hospital
  • Universitätsspital Basel
  • Cantonal Hospital St.Gallen
  • Chang Gung Memorial Hospital - Linkou
  • Hualien Tzu-Chi Hospital
  • Chang Gung Memorial Hospital - Kaohsiung Branch
  • Kaohsiung Veterans General Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • Chi-Mei Medical Center
  • National Taiwan University Hospital
  • Taipei Medical University Hospital
  • Maidstone Hospital
  • Whipps Cross University Hospital
  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
  • Guy's Hospital
  • St. George's University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

2 mg Baricitinib

4 mg Baricitinib

Placebo Maximum Extended Enrollment (MEE)

2 mg Baricitinib (MEE)

4 mg Baricitinib (MEE)

Arm Description

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.

Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.

Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.

Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.

Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.

Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 1, 2018
Last Updated
January 4, 2023
Sponsor
Eli Lilly and Company
Collaborators
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03616912
Brief Title
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Acronym
SLE-BRAVE I
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to insufficient evidence to support a positive benefit: risk profile in systemic lupus erythematosus patients.
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
March 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
SLE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
830 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
2 mg Baricitinib
Arm Type
Experimental
Arm Description
Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Arm Title
4 mg Baricitinib
Arm Type
Experimental
Arm Description
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Arm Title
Placebo Maximum Extended Enrollment (MEE)
Arm Type
Placebo Comparator
Arm Description
Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
Arm Title
2 mg Baricitinib (MEE)
Arm Type
Experimental
Arm Description
Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
Arm Title
4 mg Baricitinib (MEE)
Arm Type
Experimental
Arm Description
Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
LY3009104
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)
Description
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).
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving SRI-4 Response - 2 mg Baricitinib
Description
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).
Time Frame
Week 52
Title
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
Description
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.
Time Frame
Week 52
Title
Time to First Severe Flare
Description
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.
Time Frame
Baseline to Week 52
Title
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
Description
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.
Time Frame
Baseline, Week 40 through Week 52
Title
Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
Description
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.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score
Description
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.
Time Frame
Baseline, Week 52
Title
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
Description
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.
Time Frame
Week 52
Title
Change From Baseline in Tender Joints Count
Description
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.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Swollen Joint Count
Description
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.
Time Frame
Baseline, Week 52
Title
Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)
Description
PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) was evaluated using population PK approach.
Time Frame
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
Title
Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)
Description
Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) was evaluated using population PK approach.
Time Frame
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

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://trials.lillytrialguide.com/en-US/trial/64a5deI4M0sSScwYIMISsIDescriptionAStudyofBaricitinib(LY3009104)inParticipantsWithSystemicLupusErythematosus
Citations:
PubMed Identifier
33687069
Citation
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.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/64a5deI4M0sSScwYIMISsI
Description
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus

Learn more about this trial

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

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