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

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

The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 778
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1181AAX
    • Sanatorio Guemes Cardiocirugia
  • Mendoza, Argentina, M5500CPH
    • IR Medical Center S.A. Instituto de Reumatologia
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1046AAQ
      • Aprillus Asistencia e Investigacion - Servicio de neurologia
    • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1111AAH
      • DOM Centro de Reumatología
    • La Plata, Buenos Aires, Argentina, B1902COS
      • Framingham Centro Medico
    • Quilmes, Buenos Aires, Argentina, B1878DVC
      • Cer Instituto Medico
    • Quilmes, Buenos Aires, Argentina, B1878GEG
      • Instituto de Investigaciones Clinicas Quilmes
  • Ciudad Autonoma De Buenos Aire
    • Buenos Aires, Ciudad Autonoma De Buenos Aire, Argentina, C1431FWO
      • Comite de Etica en Investigacion - CEMIC
  • Ciudad Autónoma De Buenos Aire
    • Caba, Ciudad Autónoma De Buenos Aire, Argentina, C1430EGF
      • Clinica Adventista Belgrano
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Sanatorio Británico
  • Tucumán
    • SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
      • Centro Medico Privado de Reumatologia
• Chile
  • Osorno, Chile, 5290000
    • Clinica Alemana de Osorno
  • Santiago, Chile, 7510186
    • Sociedad Medica Del Aparato Locomotor SA
  • Santiago, Chile
    • Prosalud y cia. Ltda.
  • Vina del Mar, Chile, 2570017
    • ReumaCen Centro Reumatologico Integral
  • Los Ríos
    • Valdivia, Los Ríos, Chile, 5110683
      • Clinical Research Chile SpA
  • Región Metropolitana De Santia
    • Providencia, Región Metropolitana De Santia, Chile, 7500587
      • Enroll Spa
• Colombia
  • Chia, Colombia
    • Preventive Care Ltdac
  • Antioquia
    • Medellin, Antioquia, Colombia
      • HPTU-El Hospital con alma Pablo Tobon Uribe
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Clinica de la Costa
  • Atlántico
    • Barranquilla, Atlántico, Colombia
      • Circaribe SAS
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Idearg S.A.S.
    • Bogotá, Cundinamarca, Colombia
      • Centro Integral De Reumatologia E Inmunologia
  • Santander
    • Bucaramanga, Santander, Colombia, 12345
      • Servimed S.A.S.
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia
      • Centro de Medicina Interna
• France
  • Bordeaux, France, 33076
    • Centre hospitalier universitaire Pellegrin
  • Marseille, France, 13003
    • Hôpital Européen
  • Finistère
    • Brest Cedex, Finistère, France, 29609
      • CHRU Brest - Hôpital Cavale Blanche
  • Gironde
    • Pessac, Gironde, France, 33604
      • Centre hospitalier universitaire de Haut Leveque
  • Hérault
    • Montpellier, Hérault, France, 34295
      • CHU Montpellier Lapeyronie Hospital
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500003
      • Krishna Institute of Medical Science
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • CIMS Hospital Private Limited
    • Ahmedabad, Gujarat, India, 380005
      • Panchshil Hospital
    • Ahmedabad, Gujarat, India, 38006
      • NHL Municipal Medical College & VS General Hospital
    • Rajkot, Gujarat, India, 360004
      • Shree Giriraj Hospital
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital Private Limited
    • Vadodara, Gujarat, India, 390007
      • Sterling Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560034
      • St. John Medical College & Hospital
    • Bangalore, Karnataka, India, 560079
      • ChanRe Rheumatology And Immunology Center And Research
    • Hubli, Karnataka, India, 580021
      • Sushruta Multispecialty Hospital & Research Center Pvt Ltd
    • Madhav Nagar, Manipal, Karnataka, India, 576104
      • Kasturba Medical College Hospital, Mangalore
  • Maharashtra
    • Nagpur, Maharashtra, India, 44012
      • Jasleen Hospital
    • Nashik, Maharashtra, India, 422101
      • Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Fortis Escorts Hospital
• Italy
  • Genova, Italy, 16132
    • IRCCS Ospedale Policlinico San Martino
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
  • Roma, Italy, 00161
    • Azienda Policlinico Umberto I
  • Udine, Italy, 33100
    • Azienda Ospedaliera Santa Maria della Misericordia
  • MO
    • Modena, MO, Italy, 41124
      • Azienda Ospedaliera Universitaria
  • Toscana
    • Pisa, Toscana, Italy, 56100
      • Azienda Ospedaliera Universitaria Pisana
• Japan
  • Fukuoka, Japan, 810-8539
    • Hamanomachi Hospital
  • Fukuoka, Japan, 810 8563
    • National Hospital Organization Kyushu Medical Center
  • Tokyo, Japan, 113-8603
    • Nippon Medical School Hospital
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 807-8556
      • University of Occupational and Enviromental Health
  • Hiroshima-ken
    • Hiroshima-shi, Hiroshima-ken, Japan, 734-8551
      • Hiroshima University Hospital
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-8644
      • National Hospital Organization Asahikawa Medical Center
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyogo
    • Himeji, Hyogo, Japan, 670-8540
      • Jp Red Cross Society Himeji Hp
    • Kobe, Hyogo, Japan, 650-0017
      • Kobe University Hospital
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Kagawa University Hospital
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Chuo-Ku, Tokyo, Japan, 104 8560
      • St. Lukes International Hospital
    • Meguro-ku, Tokyo, Japan, 153-8515
      • Toho University Ohashi Med C
    • Shinagawa-ku, Tokyo, Japan, 142-8666
      • Showa University Hospital
    • Shinjuku-Ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
  • Korea
    • Daegu, Korea, Korea, Republic of, 41944
      • Kyung Pook National University Hospital
    • Incheon, Korea, Korea, Republic of, 21565
      • Gachon University Gil Hospital
    • Seoul, Korea, Korea, Republic of, 04763
      • Hanyang University Medical Center
  • Seoul
    • Seocho-Gu, Seoul, Korea, Republic of, 06591
      • The Catholic University of Korea-Seoul St. Mary's Hospital
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
      • Asan Medical Center
• Philippines
  • Cebu City, Philippines, 6000
    • Chong Hua Medical Arts Center
  • Makati City, Philippines, 1229
    • Makati Medical Center
  • Quenzon City, Philippines, 1102
    • St. Luke's Medical Center
  • Batangas
    • Lipa, Batangas, Philippines, 4217
      • Mary Mediatrix Medical Center
  • Cebu
    • Cebu City, Cebu, Philippines, 6000
      • Cebu Doctors Hospital
  • Davao Del Norte
    • Davao, Davao Del Norte, Philippines, 8000
      • Southern Philippines Medical Center
  • Pampanga
    • Angeles City, Pampanga, Philippines, 2009
      • Angeles University Foundation and Medical Center
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
  • Katowice, Poland, 40-081
    • Centrum Medyczne Pratia Katowice
  • Krakow, Poland, 30-510
    • Malopolskie Centrum Medyczne s.c.
  • Krakow, Poland, 30363
    • Centrum Medyczne Plejady
  • Nadarzyn, Poland, 05-830
    • NZOZ Lecznica MAK-MED S.C.
  • Poznan, Poland, 61-545
    • Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu
  • Warszawa, Poland, 03-291
    • Centrum Medyczne AMED
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 53224
      • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
  • Lubuskie
    • Nowa Sol, Lubuskie, Poland, 67-100
      • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 00874
      • Medycyna Kliniczna
    • Warszawa, Mazowieckie, Poland, 02-691
      • Reumatika - Centrum Reumatologii
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-077
      • Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
  • Polska
    • Lublin, Polska, Poland, 20582
      • Zespol Poradni Specjalistycznych REUMED
  • Warminsko-Mazurki
    • Elblag, Warminsko-Mazurki, Poland, 82300
      • Ambulatorium Barbara Bazela
• Romania
  • Brasov, Romania, 500283
    • SC CMDTA Neomed SRL
  • Bucharest, Romania, 11025
    • Sana Medical Center
  • Bucharest, Romania, 11172
    • St. Maria Clinical Hospital
  • Bucuresti, Romania, 011172
    • Spitalul Clinic Sf Maria Bucuresti
  • Bucuresti, Romania, 020475
    • Spitalul Clinic "Dr. Ioan Cantacuzino"
  • Bucureti, Romania, 014461
    • Spitalul Euroclinic
  • Cluj
    • Napoca, Cluj, Romania, 40006
      • Napoca Emergency Clinical County Hospital
  • Dolj
    • Craiova, Dolj, Romania, 200642
      • Craiova Emergency Clinical County Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia
  • Niska Banja, Serbia, 18205
    • Institute for Treatment and Rehabilitation Niska Banja
  • Novi Sad, Serbia, 21000
    • Clinical Center of Vojvodina
• South Africa
  • Pretoria, South Africa, 0002
    • University of Pretoria
  • Durban
    • Umhlanga, Durban, South Africa, 4319
      • Suite 509 Umhlanga Netcare Medical Centre
  • Guateng
    • Parktown, Guateng, South Africa, 2000
      • Charlotte Maxeke Johannesburg Academic Hospital
  • Pretoria
    • Muckleneuk, Pretoria, South Africa, 0002
      • Jakaranda Hospital
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7506
      • Panorama Medical Centre
    • Pinelands, Western Cape, South Africa, 7405
      • Arthritis Clinical Trial Centre
    • Stellenbosch, Western Cape, South Africa, 7600
      • Winelands Medical Research Centre
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 8036
    • Corporacio Sanitaria Clinic
  • Sevilla, Spain, 41010
    • Hospital Quiron Infanta Luisa
  • Alicante
    • La Vila Joiosa, Alicante, Spain, 03570
      • Hospital Marina Baixa
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28944
      • Hospital De Fuenlabrada
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Hospital Do Meixoeiro
  • Sapin
    • Sabadell, Sapin, Spain, 08208
      • Corporacion Sanitaria Parc Tauli
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • University of Arizona Arthritis Center
    • Phoenix, Arizona, United States, 85302
      • Arizona Arthritis & Rheumatology Research
    • Tucson, Arizona, United States, 85704
      • Arizona Arthritis & Rheumatology Associates, P. C.
  • California
    • Beverly Hills, California, United States, 90211
      • Wallace Rheumatic Studies Center
    • Covina, California, United States, 91722
      • Medvin Clinical Research - Weidmann
    • Tustin, California, United States, 92780
      • Office: Dr Robin K Dore
    • Upland, California, United States, 91786
      • Inland Rheumatology & Osteoporosis Medical Group
  • Colorado
    • Denver, Colorado, United States, 80230
      • Denver Arthritis Clinic - Lowry
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida, Inc. (Clearwater)
    • Ormond Beach, Florida, United States, 32174
      • Millennium Research
    • Plantation, Florida, United States, 33324
      • Integral Rheumatology & Immunology Specialists
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida
    • Tampa, Florida, United States, 33614
      • Tampa Medical Group, P.A.
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Lawrenceville, Georgia, United States, 30046
      • North Georgia Rheumatology, PC
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Arthritis Center of Lexington
  • Maryland
    • Baltimore, Maryland, United States, 21224-6801
      • Johns Hopkins University School of Medicine
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Advanced Rheumatology, PC
  • Montana
    • Kalispell, Montana, United States, 59901
      • Glacier View Research Institute - Endocrinology
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Innovative Health Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
    • Las Cruces, New Mexico, United States, 88011
      • Arthritis and Osteoporosis Associates of New Mexico
  • New York
    • Canton, New York, United States, 13617
      • St. Lawrence Health System
    • New York, New York, United States, 10016
      • New York University Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Box Arthritis & Rheumatology of the Carolinas, PLLC
    • Charlotte, North Carolina, United States, 28204
      • Joint and Muscle Medical Care
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Rheumatic Disease Study Group
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Medical Research Foundation
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading,LLC
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
  • Tennessee
    • Crossville, Tennessee, United States, 38555
      • Eagle Medical
  • Texas
    • Colleyville, Texas, United States, 76034
      • Dr. Dhiman Basu Private Practice
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • The Woodlands, Texas, United States, 77382
      • Advanced Rheumatology of Houston
    • Webster, Texas, United States, 77598
      • Clear Lake Specialties
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Arthritis Clinic of Northern VA, P.C.
    • Danville, Virginia, United States, 24541
      • Spectrum Medical Inc.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
• Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
• Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
• Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
• Have a clinical SLEDAI-2K score ≥4 at randomization.
• Have at least 1 British Isles Lupus Assessment Group (BILAG) A score or 2 BILAG B scores during screening.

• Are receiving at least one of the following standard of care medications for SLE:

  • A single antimalarial at a stable dose for at least 8 weeks prior to screening
  • A single immunosuppressant at a stable dose for at least 8 weeks prior to screening
  • An oral corticosteroid, initiated at least 4 weeks prior to screening, at a stable dose ≤40 milligrams/day prednisone (or equivalent) for at least 2 weeks prior to screening. If the participant is not receiving an antimalarial or immunosuppressant, the dose of corticosteroid must be ≥7.5 milligrams/day prednisone (or equivalent)

Exclusion Criteria:

• Have severe active lupus nephritis.
• Have active central nervous system (CNS) lupus.
• Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
• Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
• Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 2 milligram (mg) Baricitinib; Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks.	Drug: Placebo; Administered orally; Drug: Baricitinib; Administered orally.; Other Names: LY3009104
EXPERIMENTAL: 4 mg Baricitinib; Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.	Drug: Placebo; Administered orally; Drug: Baricitinib; Administered orally.; Other Names: LY3009104
PLACEBO_COMPARATOR: Placebo; 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.	Drug: Placebo; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib)	SRI-4 response defined as 1)greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)	The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg daily.	Week 52
Percentage of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Participants Receiving Greater Than 7.5 mg/Day at Baseline	For the analysis of steroid use, steroid dosages were converted to a prednisone equivalent in mg. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52.	Baseline, Week 40 through Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score	FACIT-Fatigue score calculated according to a 13-item questionnaire that assess self reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status. Least Squares (LS) mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >= 10 mg/day prednisone or equivalent), region (North America, Central/South, America/Mexico, Europe, Asia Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.	Baseline, Week 52
Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline With ≥50% Reduction in CLASI Total Activity Score	The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.	Week 52
Change From Baseline in Swollen Joint Count	The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.	Baseline, Week 52
Percentage of Participants Achieving SRI-4 Response (2 mg Baricitinib)	SRI-4 response defined as 1)greater than or equal to (>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assess disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).	Week 52
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.	Baseline to Week 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.	Baseline, Week 52
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.	Baseline, Week 52
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.	Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose
Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss)	PK: Maximum Concentration of Baricitinib at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach.	Week 0 (Baseline): 15 minutes (min) and 60 min postdose; Week 4: 2 to 4 hours (hr) postdose; Week 8: 4 to 6 hr postdose; Week 12 and Week 16 predose

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Helpful Links

• A Study of Baricitinib in Participants With Systemic Lupus Erythematosus

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2018
• Primary Completion (ACTUAL): September 24, 2021
• Study Completion (ACTUAL): October 20, 2021

Study Registration Dates

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

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: SLE
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 16677; I4V-MC-JAIA (OTHER: Eli Lilly and Company); 2017-005027-25 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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