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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
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

  • University of Arizona Arthritis Center
  • Arizona Arthritis & Rheumatology Research
  • Arizona Arthritis & Rheumatology Associates, P. C.
  • Wallace Rheumatic Studies Center
  • Medvin Clinical Research - Weidmann
  • Office: Dr Robin K Dore
  • Inland Rheumatology & Osteoporosis Medical Group
  • Denver Arthritis Clinic - Lowry
  • Clinical Research of West Florida, Inc. (Clearwater)
  • Millennium Research
  • Integral Rheumatology & Immunology Specialists
  • Clinical Research of West Florida
  • Tampa Medical Group, P.A.
  • Emory University
  • Northside Hospital
  • North Georgia Rheumatology, PC
  • Arthritis Center of Lexington
  • Johns Hopkins University School of Medicine
  • Advanced Rheumatology, PC
  • Glacier View Research Institute - Endocrinology
  • Innovative Health Research
  • Albuquerque Clinical Trials, Inc.
  • Arthritis and Osteoporosis Associates of New Mexico
  • St. Lawrence Health System
  • New York University Medical Center
  • SUNY Upstate Medical University
  • Joint and Muscle Medical Care
  • Box Arthritis & Rheumatology of the Carolinas, PLLC
  • Cincinnati Rheumatic Disease Study Group
  • Oklahoma Medical Research Foundation
  • Clinical Research Center of Reading,LLC
  • Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
  • Eagle Medical
  • Dr. Dhiman Basu Private Practice
  • Metroplex Clinical Research Center
  • Advanced Rheumatology of Houston
  • Clear Lake Specialties
  • Arthritis Clinic of Northern VA, P.C.
  • Spectrum Medical Inc.
  • Aprillus Asistencia e Investigacion - Servicio de neurologia
  • DOM Centro de Reumatologia
  • Framingham Centro Medico
  • CER Instituto Medico
  • Instituto de Investigaciones Clinicas Quilmes
  • Comite de Etica en Investigacion - CEMIC
  • Clinica Adventista Belgrano
  • Sanatorio Británico
  • Centro Medico Privado de Reumatologia
  • Sanatorio Guemes Cardiocirugia
  • IR Medical Center S.A. Instituto de Reumatologia
  • Clinical Research Chile SpA
  • Enroll SpA
  • Clinica Alemana de Osorno
  • Sociedad Medica Del Aparato Locomotor SA
  • Prosalud y cia. Ltda.
  • ReumaCen Centro Reumatologico Integral
  • HPTU-El Hospital con alma Pablo Tobon Uribe
  • Clinica de la Costa
  • Circaribe SAS
  • Idearg S.A.S.
  • Centro Integral de Reumatologia e Inmunologia
  • Servimed S.A.S.
  • Centro de Medicina Interna
  • Preventive Care Ltdac
  • CHRU Brest - Hopital Cavale Blanche
  • Centre hospitalier universitaire de Haut Leveque
  • CHU Montpellier Lapeyronie Hospital
  • Centre hospitalier universitaire Pellegrin
  • Hopital Européen
  • Krishna Institute of Medical Science
  • Panchshil Hospital
  • CIMS Hospital Private Limited
  • NHL Municipal Medical College & VS General Hospital
  • Shree Giriraj Hospital
  • Nirmal Hospital Private Limited
  • Sterling Hospital
  • St. John Medical College & Hospital
  • ChanRe Rheumatology And Immunology Center And Research
  • Sushruta Multispecialty Hospital & Research Center Pvt Ltd
  • Kasturba Medical College Hospital, Mangalore
  • Jasleen Hospital
  • Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
  • Fortis Escorts Hospital
  • Azienda Ospedaliera Universitaria
  • Azienda Ospedaliera Universitaria Pisana
  • IRCCS Ospedale Policlinico San Martino
  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
  • Azienda Policlinico Umberto I
  • Azienda Ospedaliera Santa Maria Della Misericordia
  • University of Occupational and Enviromental Health
  • Hiroshima University Hospital
  • National Hospital Organization Asahikawa Medical Center
  • Hokkaido University Hospital
  • Jp Red Cross Society Himeji Hp
  • Kobe University Hospital
  • Kagawa University Hospital
  • Tohoku University Hospital
  • Juntendo University Hospital
  • St. Lukes International Hospital
  • Toho University Ohashi Med C
  • Showa University Hospital
  • Keio University Hospital
  • National Hospital Organization Kyushu Medical Center
  • Hamanomachi Hospital
  • Nippon Medical School Hospital
  • Seoul National University Bundang Hospital
  • Kyung Pook National University Hospital
  • Gachon University Gil Hospital
  • Hanyang University Medical Center
  • Asan Medical Center
  • The Catholic University of Korea-Seoul St. Mary's Hospital
  • Mary Mediatrix Medical Center
  • Cebu Doctors Hospital
  • Southern Philippines Medical Center
  • Angeles University Foundation and Medical Center
  • Chong Hua Medical Arts Center
  • Makati Medical Center
  • St. Luke's Medical Center
  • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
  • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • Medycyna Kliniczna
  • Reumatika - Centrum Reumatologii
  • Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
  • Zespol Poradni Specjalistycznych REUMED
  • Ambulatorium Barbara Bazela
  • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
  • Centrum Medyczne Pratia Katowice
  • Malopolskie Centrum Medyczne S.C.
  • Centrum Medyczne Plejady
  • NZOZ Lecznica MAK-MED s.c.
  • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu
  • Centrum Medyczne AMED
  • Napoca Emergency Clinical County Hospital
  • Craiova Emergency Clinical County Hospital
  • SC CMDTA Neomed SRL
  • SANA Medical Center
  • St. Maria Clinical Hospital
  • Spitalul Clinic Sf Maria Bucuresti
  • Spitalul Clinic "Dr. Ioan Cantacuzino"
  • Spitalul Euroclinic
  • Institute of Rheumatology
  • Military Medical Academy
  • University Clinical Center of Serbia
  • Institute for Treatment and Rehabilitation Niska Banja
  • Clinical Center of Vojvodina
  • Suite 509 Umhlanga Netcare Medical Centre
  • Charlotte Maxeke Johannesburg Academic Hospital
  • Jakaranda Hospital
  • Panorama Medical Centre
  • Arthritis Clinical Trial Centre
  • Winelands Medical Research Centre
  • University Of Pretoria
  • Hospital Marina Baixa
  • Hospital De Fuenlabrada
  • Hospital do Meixoeiro
  • Corporacion Sanitaria Parc Tauli
  • Hospital Universitari Vall d'Hebron
  • Corporació Sanitària Clínic
  • Hospital Quiron Infanta Luisa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

2 milligram (mg) Baricitinib

4 mg Baricitinib

Placebo

Arm Description

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

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

Participants received 2 placebo tablets: one placebo tablet matching 4 mg baricitinib and one placebo tablet matching 2 mg baricitinib administered orally 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 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 the 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 Joint 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 for Dosing Interval of Baricitinib at Steady State (AUCtau,ss)
AUCtau,ss reported for participants who received multiple doses of mg baricitinib was derived by a population pharmacokinetics approach.
Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)
PK: Maximum Concentration of Baricitinib at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach.

Full Information

First Posted
August 1, 2018
Last Updated
November 1, 2022
Sponsor
Eli Lilly and Company
Collaborators
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03616964
Brief Title
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)
Acronym
BRAVE II
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
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
September 24, 2021 (Actual)
Study Completion Date
October 20, 2021 (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
778 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 milligram (mg) Baricitinib
Arm Type
Experimental
Arm Description
Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks.
Arm Title
4 mg Baricitinib
Arm Type
Experimental
Arm Description
Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 2 placebo tablets: one placebo tablet matching 4 mg baricitinib and one placebo tablet matching 2 mg baricitinib administered orally 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 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 the 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 Joint 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 for Dosing Interval of Baricitinib at Steady State (AUCtau,ss)
Description
AUCtau,ss reported for participants who received multiple doses of mg baricitinib was derived by a population pharmacokinetics 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
PK: Maximum Concentration of Baricitinib at steady-state (Cmax,ss) was derived by a population pharmacokinetics 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
University of Arizona Arthritis Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85302
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, P. C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Wallace Rheumatic Studies Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Medvin Clinical Research - Weidmann
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Office: Dr Robin K Dore
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Inland Rheumatology & Osteoporosis Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Denver Arthritis Clinic - Lowry
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
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
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Tampa Medical Group, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
North Georgia Rheumatology, PC
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Arthritis Center of Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224-6801
Country
United States
Facility Name
Advanced Rheumatology, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Glacier View Research Institute - Endocrinology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Innovative Health Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Arthritis and Osteoporosis Associates of New Mexico
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
St. Lawrence Health System
City
Canton
State/Province
New York
ZIP/Postal Code
13617
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
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
Box Arthritis & Rheumatology of the Carolinas, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cincinnati Rheumatic Disease Study Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Clinical Research Center of Reading,LLC
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
Eagle Medical
City
Crossville
State/Province
Tennessee
ZIP/Postal Code
38555
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
Advanced Rheumatology of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
Clear Lake Specialties
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Arthritis Clinic of Northern VA, P.C.
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Spectrum Medical Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Aprillus Asistencia e Investigacion - Servicio de neurologia
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1046AAQ
Country
Argentina
Facility Name
DOM Centro de Reumatologia
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1111AAH
Country
Argentina
Facility Name
Framingham Centro Medico
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902COS
Country
Argentina
Facility Name
CER Instituto Medico
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVC
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Quilmes
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Comite de Etica en Investigacion - CEMIC
City
Buenos Aires
State/Province
Ciudad Autonoma De Buenos Aire
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Clinica Adventista Belgrano
City
Caba
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Sanatorio Británico
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
SAN M. DE Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Sanatorio Guemes Cardiocirugia
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1181AAX
Country
Argentina
Facility Name
IR Medical Center S.A. Instituto de Reumatologia
City
Mendoza
ZIP/Postal Code
M5500CPH
Country
Argentina
Facility Name
Clinical Research Chile SpA
City
Valdivia
State/Province
Los Ríos
ZIP/Postal Code
5110683
Country
Chile
Facility Name
Enroll SpA
City
Providencia
State/Province
Región Metropolitana De Santia
ZIP/Postal Code
7500587
Country
Chile
Facility Name
Clinica Alemana de Osorno
City
Osorno
ZIP/Postal Code
5290000
Country
Chile
Facility Name
Sociedad Medica Del Aparato Locomotor SA
City
Santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Prosalud y cia. Ltda.
City
Santiago
Country
Chile
Facility Name
ReumaCen Centro Reumatologico Integral
City
Vina del Mar
ZIP/Postal Code
2570017
Country
Chile
Facility Name
HPTU-El Hospital con alma Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Clinica de la Costa
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Circaribe SAS
City
Barranquilla
State/Province
Atlántico
Country
Colombia
Facility Name
Idearg S.A.S.
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Centro Integral de Reumatologia e Inmunologia
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
Facility Name
Servimed S.A.S.
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
12345
Country
Colombia
Facility Name
Centro de Medicina Interna
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
Facility Name
Preventive Care Ltdac
City
Chia
Country
Colombia
Facility Name
CHRU Brest - Hopital Cavale Blanche
City
Brest Cedex
State/Province
Finistère
ZIP/Postal Code
29609
Country
France
Facility Name
Centre hospitalier universitaire de Haut Leveque
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Montpellier Lapeyronie Hospital
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34295
Country
France
Facility Name
Centre hospitalier universitaire Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Européen
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Krishna Institute of Medical Science
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
Panchshil Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380005
Country
India
Facility Name
CIMS Hospital Private Limited
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380060
Country
India
Facility Name
NHL Municipal Medical College & VS General Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
38006
Country
India
Facility Name
Shree Giriraj Hospital
City
Rajkot
State/Province
Gujarat
ZIP/Postal Code
360004
Country
India
Facility Name
Nirmal Hospital Private Limited
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Sterling Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390007
Country
India
Facility Name
St. John Medical College & Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
ChanRe Rheumatology And Immunology Center And Research
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560079
Country
India
Facility Name
Sushruta Multispecialty Hospital & Research Center Pvt Ltd
City
Hubli
State/Province
Karnataka
ZIP/Postal Code
580021
Country
India
Facility Name
Kasturba Medical College Hospital, Mangalore
City
Madhav Nagar, Manipal
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Facility Name
Jasleen Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
44012
Country
India
Facility Name
Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422101
Country
India
Facility Name
Fortis Escorts Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Azienda Ospedaliera Universitaria
City
Modena
State/Province
MO
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Facility Name
IRCCS Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria Della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
University of Occupational and Enviromental Health
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
State/Province
Hiroshima-ken
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Jp Red Cross Society Himeji Hp
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8540
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Kagawa University Hospital
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
St. Lukes International Hospital
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104 8560
Country
Japan
Facility Name
Toho University Ohashi Med C
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810 8563
Country
Japan
Facility Name
Hamanomachi Hospital
City
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Kyung Pook National University Hospital
City
Daegu
State/Province
Korea
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
State/Province
Korea
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
The Catholic University of Korea-Seoul St. Mary's Hospital
City
Seocho-Gu
State/Province
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Mary Mediatrix Medical Center
City
Lipa
State/Province
Batangas
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Cebu Doctors Hospital
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Southern Philippines Medical Center
City
Davao
State/Province
Davao Del Norte
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Angeles University Foundation and Medical Center
City
Angeles City
State/Province
Pampanga
ZIP/Postal Code
2009
Country
Philippines
Facility Name
Chong Hua Medical Arts Center
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Makati Medical Center
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quenzon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53224
Country
Poland
Facility Name
Twoja Przychodnia Centrum Medyczne Nowa Sol
City
Nowa Sol
State/Province
Lubuskie
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Medycyna Kliniczna
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00874
Country
Poland
Facility Name
Reumatika - Centrum Reumatologii
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-077
Country
Poland
Facility Name
Zespol Poradni Specjalistycznych REUMED
City
Lublin
State/Province
Polska
ZIP/Postal Code
20582
Country
Poland
Facility Name
Ambulatorium Barbara Bazela
City
Elblag
State/Province
Warminsko-Mazurki
ZIP/Postal Code
82300
Country
Poland
Facility Name
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Malopolskie Centrum Medyczne S.C.
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30363
Country
Poland
Facility Name
NZOZ Lecznica MAK-MED s.c.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu
City
Poznan
ZIP/Postal Code
61-545
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Napoca Emergency Clinical County Hospital
City
Napoca
State/Province
Cluj
ZIP/Postal Code
40006
Country
Romania
Facility Name
Craiova Emergency Clinical County Hospital
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200642
Country
Romania
Facility Name
SC CMDTA Neomed SRL
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
SANA Medical Center
City
Bucharest
ZIP/Postal Code
11025
Country
Romania
Facility Name
St. Maria Clinical Hospital
City
Bucharest
ZIP/Postal Code
11172
Country
Romania
Facility Name
Spitalul Clinic Sf Maria Bucuresti
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic "Dr. Ioan Cantacuzino"
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Euroclinic
City
Bucureti
ZIP/Postal Code
014461
Country
Romania
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Treatment and Rehabilitation Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Clinical Center of Vojvodina
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Suite 509 Umhlanga Netcare Medical Centre
City
Umhlanga
State/Province
Durban
ZIP/Postal Code
4319
Country
South Africa
Facility Name
Charlotte Maxeke Johannesburg Academic Hospital
City
Parktown
State/Province
Guateng
ZIP/Postal Code
2000
Country
South Africa
Facility Name
Jakaranda Hospital
City
Muckleneuk
State/Province
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Panorama Medical Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7506
Country
South Africa
Facility Name
Arthritis Clinical Trial Centre
City
Pinelands
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Winelands Medical Research Centre
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Facility Name
University Of Pretoria
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Hospital Marina Baixa
City
La Vila Joiosa
State/Province
Alicante
ZIP/Postal Code
03570
Country
Spain
Facility Name
Hospital De Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28944
Country
Spain
Facility Name
Hospital do Meixoeiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36200
Country
Spain
Facility Name
Corporacion Sanitaria Parc Tauli
City
Sabadell
State/Province
Sapin
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Corporació Sanitària Clínic
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Quiron Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain

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://vivli.org/
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/MnvCKtj7wIG0g4Wo2ugIc
Description
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus

Learn more about this trial

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

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