AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 3SLE-BRAVE-XNCT03843125

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

A Phase 3 study testing Baricitinib in people with Systemic Lupus Erythematosus, run by Eli Lilly and Company at 297 sites in 32 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Baricitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,147 participants
Where
297 sitesin 32 countries
Study dates
9 Sep 2019to 1 Apr 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).

Who cannot join

None listed.

Trial locations and contacts

297 sites in 32 countries.

297 sites in 32 countries

United States61 sites

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Arthritis Clinic of Northern VA, P.C.

    Arlington, Virginia, 22205

  • Piedmont Healthcare

    Atlanta, Georgia, 30318

  • Emory University

    Atlanta, Georgia, 30322

  • Arthritis and Rheumatic Disease

    Aventura, Florida, 33180

  • Johns Hopkins Asthma and Allergy Center

    Baltimore, Maryland, 21224

  • Accurate Clinical Management

    Baytown, Texas, 77521

  • East Penn Rheumatology Associates

    Bethlehem, Pennsylvania, 18015

  • Wallace Rheumatic Studies Center

    Beverly Hills, California, 90211

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • New England Research Associates

    Bridgeport, Connecticut, 06606

  • St. Lawrence Health System

    Canton, New York, 13617

  • Joint and Muscle Medical Care

    Charlotte, North Carolina, 28204

  • Box Arthritis & Rheumatology of the Carolinas, PLLC

    Charlotte, North Carolina, 28210

  • Cincinnati Rheumatic Disease Study Group

    Cincinnati, Ohio, 45242

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida, 33765

  • Dr. Dhiman Basu Private Practice

    Colleyville, Texas, 76034

  • Medvin Clinical Research - Weidmann

    Covina, California, 91722

  • Eagle Medical

    Crossville, Tennessee, 38555

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Spectrum Medical Inc.

    Danville, Virginia, 24541

  • Denver Arthritis Clinic - Lowry

    Denver, Colorado, 80230

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Precision Comprehensive Clinical Research Solutions

    Fort Worth, Texas, 76107

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Medication Management

    Greensboro, North Carolina, 27408

  • MD Medical Corporation

    Hemet, California, 92543

  • Rheumatology Center Of Houston

    Houston, Texas, 77004

  • Accurate Clinical Research

    Houston, Texas, 77089

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Glacir View Research Institute

    Kalispell, Montana, 59901

  • Advanced Rheumatology, PC

    Lansing, Michigan, 48910

  • Arthritis and Osteoporosis Associates of New Mexico

    Las Cruces, New Mexico, 88011

  • North Georgia Rheumatology, PC

    Lawrenceville, Georgia, 30046

  • Arthritis Center of Lexington

    Lexington, Kentucky, 40504

  • The Feinstein Institute for Medical Research

    Manhasset, New York, 11030

  • Southwest Rheumatology, P.A.

    Mesquite, Texas, 75150

  • Lakes Research, LLC

    Miami Lakes, Florida, 33014

  • Paramount Medical Research

    Middleburg Heights, Ohio, 44130

  • Columbia University Medical Center

    New York, New York, 10032

  • NYU Langone

    New York, New York, 11201

  • Arthritis & Rheumatology Center of Oklahoma PLLC

    Oklahoma City, Oklahoma, 73102

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104-5046

  • Millennium Research

    Ormond Beach, Florida, 32174

  • Arizona Arthritis & Rheumatology Research

    Phoenix, Arizona, 85032

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida, 33324

  • IRIS Research and Development, LLC

    Plantation, Florida, 33324

  • ACRC Studies

    Poway, California, 92064

  • Allied Clinical Research

    Reno, Nevada, 89519

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan, 48081

  • Accurate Clinical Research, Inc.

    San Antonio, Texas, 78229

  • Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

    Summerville, South Carolina, 29486

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • ForCare Clinical Research

    Tampa, Florida, 33613-1244

  • Tampa Medical Group, P.A.

    Tampa, Florida, 33614

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382

  • Arizona Arthritis & Rheumatology Associates, P. C.

    Tucson, Arizona, 85704

  • Inland Rheumatology & Osteoporosis Medical Group

    Upland, California, 91786

  • Medvin Clinical Research - Weidmann

    Whittier, California, 90602

  • Clinical Research Center of Reading,LLC

    Wyomissing, Pennsylvania, 19610

Other trials in United States

China17 sites

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Peking Union Medical College Hospital

    Beijing, 100730

  • China-Japan Union Hospital, CJUH.

    Changchun, Jilin, 130033

  • First affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • First Affiliated Hospital of the Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210000

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Huashan Hospital Affil to Fu Dan University

    Shanghai, 200040

  • China Medical University (CMU) - First Affiliated Hospital

    Shenyang, 110001

  • The First Affliated Hospital of Suzhou University

    Suzhou, China, 215000

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830001

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Zhengzhou Universtiy

    Zhengzhou, 450000

Other trials in China

Japan17 sites

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, Hokkaido, 070-8644

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Nippon Medical School Hospital

    Bunkyo-Ku, Tokyo, 113-8603

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810 8563

  • Hamanomachi Hospital

    Fukuoka, 810-8539

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka, 430-8558

  • Jp Red Cross Society Himeji Hp

    Himeji, Hyōgo, 670-8540

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • University of Occupational and Enviromental Health

    Kitakyushu, Fukuoka, 807-8556

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Showa University Hospital

    Shinagawa, Tokyo, 142-8555

  • St. Luke's International Hospital

    Tokyo, 104-8560

  • Keio university hospital

    Tokyo, 1600035

  • Tomishiro Central Hospital

    Tomigusuku, Okinawa, 901-0243

Other trials in Japan

Russia17 sites

  • Chelyabinsk Regional Clinical Hospital

    Chelyabinsk, 454076

  • City Hospital # 7

    Kazan', 420103

  • Moscow City Clinical Hospital Number 52

    Moscow, Moscow

  • Russian National Research Medical University n.a. N.I.Pirogov

    Moscow, Russian Federation, 117997

  • V.A. Nasonova Research Institute of Rheumatology

    Moscow, 115522

  • City Clinical Hospital 1 named after N.I. Pirogov

    Moscow, 119049

  • Research Institute of Clinical Immunology

    Novosibirsk, 630099

  • Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences

    Novosibirsk, 630117

  • Regional Hospital - Omsk

    Omsk, 644111

  • Orenburg State Medical Academy of Roszdrav

    Orenburg, 460018

  • Kursk Regional Clinical Hospital

    Rursk, 305007

  • Ryazan State Medical University

    Ryazan, 390026

  • LLC MK Med

    Saint Petersburg, Sankt-Peterburg, 197372

  • Russian Medical Military Academy n.a. S.M. Kirov

    Saint Petersburg, 194044

  • Departmental Hospital at Smolensk Station "rzhd" JSC

    Smolensk, 214025

  • Kuvatov Republican Clinical Hospital

    Ufa, 450005

  • LLC Medical Center Zdorovaya Semiya

    Zonova, 630061

Other trials in Russia

Mexico16 sites

  • Centro Integral en Reumatologia SA de CV

    Guadalajara, Jalisco, 44160

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, Jalisco, 44650

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Guadalajara, Jalisco, 44690

  • Morales Vargas Centro de Investigacion, S.C.

    León, Guanajuato, 37000

  • Centro Peninsular de Investigacion S.C.P

    Mérida, Yucatán, 97000

  • Köhler & Milstein Research

    Mérida, Yucatán, 97070

  • Cemdeicy S.C.P.

    Mérida, Yucatán, 97130

  • Clinica para el Diagnostico y Tratamiento de la Enfermedades

    Mexico City, Mexico City, 06700

  • Clinosar Mexico S.A. de C.V

    Mexico City, 06760

  • Consultorio de Reumatologia

    Mexico City, 07760

  • Centro de Investigación y Tratamiento Reumatológico S.C

    Mexico City, 11850

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

  • Centro de Alta Especialidad Reumatologia Inv del Potosi SC

    San Luis Potosí City, San Luis Potosí, 78213

  • Dr. Alberto Esteban Bazzoni Ruiz

    Torreón, Coahuila, 27000

  • Consultorio Jose Luis Garcia Figueroa

    Villahermosa, Tabasco, 89190

  • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

    Zapopan, Jalisco, 45030

Other trials in Mexico

Poland15 sites

  • Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk

    Bialystok, Podlaskie Voivodeship, 15-077

  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Ambulatorium Barbara Bazela

    Elblag, Warminsko-Mazurki, 82300

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • MCM Krakow - PRATIA - PPDS

    Krakow, 30-510

  • Centrum Medyczne Plejady

    Krakow, 30363

  • Zespol Poradni Specjalistycznych REUMED

    Lublin, Polska, 20582

  • NZOZ Lecznica MAK-MED s.c.

    Nadarzyn, 05-830

  • Twoja Przychodnia Centrum Medyczne Nowa Sol

    Nowa Sól, Lubusz Voivodeship, 67-100

  • Klinika Reumatologii i Rehabilitacji

    Poznan, 61-545

  • Klinika Reumatologii, Chorob Wewnetrznych i Geriatrii PUM

    Szczecin, 71-252

  • Medycyna Kliniczna

    Warsaw, Masovian Voivodeship, 00874

  • Reumatika - Centrum Reumatologii

    Warsaw, Masovian Voivodeship, 02-691

  • Centrum Medyczne AMED

    Warsaw, 03-291

  • Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

    Wroclaw, Lower Silesian Voivodeship, 53224

Other trials in Poland

India13 sites

  • Panchshil hospital

    Ahmedabad, Gujarat, 380005

  • CIMS Hospital Private Limited

    Ahmedabad, Gujarat, 380060

  • ChanRe Rheumatology And Immunology Center And Research

    Bangalore, Karnataka, 560010

  • St. John Medical College & Hospital

    Bangalore, Karnataka, 560034

  • Sushruta Multispecialty Hospital & Research Center Pvt Ltd

    Hubli, Karnataka, 580021

  • Fortis Escorts Hospital

    Jaipur, Rajasthan, 302017

  • Kasturba Medical College Hospital, Mangalore

    Madhav Nagar, Manipal, Karnataka, 576104

  • Jasleen Hospital

    Nagpur, Maharashtra, 440012

  • Synexus Affiliate - Sujata Birla Hospital & Medical Research Center

    Nashik, Maharashtra, 422101

  • Shree Giriraj Hospital

    Rajkot, Gujarat, 360004

  • Krishna Institute of Medical Science

    Secunderabad, Telangana, 500003

  • Nirmal Hospital Private Limited

    Surat, Gujarat, 395002

  • Sterling Hospital

    Vadodara, Gujarat, 390007

Other trials in India

Germany11 sites

  • Charité Campus Virchow-Klinikum

    Berlin, 10117

  • Immanuel Krankenhaus Rheuma Klinik Berlin Buch

    Berlin, 13125

  • Schlosspark Klinik

    Berlin, 14059

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 01307

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 4103

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum der Universität München Großhadern

    München, Bavaria, 81337

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Würzburg A. ö. R.

    Würzburg, Bavaria, 97080

Other trials in Germany

Argentina10 sites

  • Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)

    Buenos Aires, C1431FWO

  • Clinica Adventista Belgrano

    CABA, Ciudad Autónoma de Buenos Aire, C1430EGF

  • Aprillus Asistencia e Investigacion de Arcis Salud SRL

    Ciudad Autónoma de Buenos Aire, Buenos Aires, 1046

  • DOM Centro de Reumatologia

    Ciudad de Buenos Aires, Buenos Aires, C1111AAH

  • Framingham Centro Medico

    La Plata, Buenos Aires, B1902COS

  • IR Medical Center S.A. Instituto de Reumatologia

    Mendoza, M5500CPH

  • CER Instituto Medico

    Quilmes, Buenos Aires, B1878DVC

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes, Buenos Aires, B1878GEG

  • Sanatorio Británico

    Rosario, Santa Fe Province, 2000

  • Centro de Investigaciones Médicas Tucuman

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Hungary10 sites

  • Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • Qualiclinic

    Budapest, 1036

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

    Debrecen, 4004

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

    Gyula, Bekes County, 5700

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7632

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika

    Szeged, 6725

  • Vita Verum Egeszsegugyi Szolgaltato Bt

    Székesfehérvár, 8000

  • Vital Medical Center

    Veszprém, Veszprém City, 8200

Other trials in Hungary

Taiwan9 sites

  • Hualien Tzu-Chi Hospital

    Dalin Township, 622

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Chi-Mei Medical Center

    Tainan, 71004

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Medical University Hospital

    Taipei, 110

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 33305

Other trials in Taiwan

Brazil7 sites

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • Hospital de Clinicas UNICAMP

    Campinas, São Paulo, 13083-970

  • Oncovida- Centro de Onco-Hematologia de Mato Grosso

    Cuiabá, 78043-142

  • Centro de Estudos em Terapias Inovadoras-CETI

    Curitiba, Paraná, 80030-110

  • EDUMED - Educação em Saúde Ltda.

    Curitiba, Paraná, 80440-080

  • LMK Serviços Médicos S/S

    Porto Alegre, Rio Grande do Sul, 90540-000

  • SER - Serviços Especializados em Reumatologia da Bahia S/S - ME

    Salvador, Estado de Bahia, 40150-150

Other trials in Brazil

Colombia7 sites

  • Clinica de la Costa

    Barranquilla, Atlántico, 080020

  • Circaribe SAS

    Barranquilla, Atlántico

  • Idearg S.A.S.

    Bogota, Cundinamarca

  • Servimed S.A.S.

    Bucaramanga, Santander Department, 12345

  • Centro de Medicina Interna

    Cali, Valle del Cauca Department

  • Preventive Care Ltdac

    Chía

  • HPTU-El Hospital con alma Pablo Tobon Uribe

    Medellín, Antioquia

Other trials in Colombia

Philippines7 sites

  • Angeles University Foundation and Medical Center

    Angeles City, Pampanga, 2009

  • Cebu Doctors Hospital

    Cebu City, Cebu, 6000

  • Chong Hua Hospital

    Cebu City, Cebu, 6000

  • Southern Philippines Medical Center

    Davao City, Davao Del Norte, 8000

  • Mary Mediatrix Medical Center

    Lipa, Batangas, 4217

  • Makati Medical Center

    Makati, Luzon, 1229

  • St. Luke's Medical Center

    Quezon City, Luzon, 1102

Other trials in Philippines

Romania7 sites

  • C.M.D.T.A. Neomed

    Brasov, Brașov County, 500283

  • Spitalul Clinic Sf Maria Bucuresti

    Bucharest, 011172

  • Spitalul Clinic "Dr. Ioan Cantacuzino"

    Bucharest, 020475

  • SANA Medical Center

    Bucharest, 11025

  • Spitalul Euroclinic

    Bucureti, Bucharest, 14461

  • Napoca Emergency Clinical County Hospital

    Cluj-Napoca, Cluj, 40006

  • Craiova Emergency Clinical County Hospital

    Craiova, Dolj, 200642

Other trials in Romania

South Africa7 sites

  • Vincent Pallotti Hospital

    Cape Town, Western Cape, 7405

  • Panorama Medical Centre

    Cape Town, Western Cape, 7500

  • WITS Clinical Research

    Johannesburg, Gauteng, 2193

  • Jakaranda Hospital

    Pretoria, Gauteng, 0002

  • University Of Pretoria

    Pretoria, 0002

  • Winelands Medical Research Centre

    Stellenbosch, Western Cape, 7600

  • Suite 509 Umhlanga Netcare Medical Centre

    Umhlanga, Durban, 4319

Other trials in South Africa

South Korea7 sites

  • Kyung Pook National University Hospital

    Daegu, Korea, 41944

  • Chungnam National University Hospital

    Daejeon, Korea, 35015

  • Gachon University Gil Hospital

    Incheon, Korea, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Hanyang University Medical Center

    Seoul, Korea, 04763

  • Asan Medical Center

    Seoul, Korea, 05505

  • Seoul St. Mary's Hospital

    Seoul, Korea, 06591

Other trials in South Korea

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 8035

  • Corporació Sanitària Clínic

    Barcelona, 8036

  • Hospital De Fuenlabrada

    Fuenlabrada, Madrid, 28944

  • Corporacion Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Quiron Infanta Luisa

    Seville, 41010

  • Hospital do Meixoeiro

    Vigo, Pontevedra, 36200

  • Hospital Marina Baixa

    Villajoyosa, Alicante, 03570

Other trials in Spain

Chile6 sites

  • Clinica Alemana de Osorno

    Osorno, 5290000

  • Enroll SpA

    Providencia, Región Metropolitana de Santia, 7500587

  • Sociedad Medica Del Aparato Locomotor SA

    Santiago, 7510186

  • Prosalud y cia. Ltda.

    Santiago

  • Clinical Research Chile SpA

    Valdivia, Los Ríos Region, 5110683

  • CINVEC- Estudos Clínicos Quinta Región Limitada

    Viña del Mar, 2570017

Other trials in Chile

United Kingdom6 sites

  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

    Doncaster, DN2 5LT

  • Leeds Teaching Hospital

    Leeds, LS7 4SA

  • Whipps Cross University Hospital

    Leytonstone, London, E11 1NR

  • Guys/St. Thomas Hospital

    London, Surrey, SE1 9RT

  • Maidstone Hospital

    Maidstone, Kent, ME16 9QQ

  • St George's Hospital

    Tooting, London, SW17 0QT

Other trials in United Kingdom

Czechia5 sites

  • Revmatologie.s.r.o.

    Brno, 638 00

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • ARTHROHELP s.r.o.

    Pardubice, 53002

  • Revmatologicky ustav

    Prague, Praha, Hlavní Mešto, 12850

  • VFN a 1 LF University Karlovy

    Prague, 128 08

Other trials in Czechia

France5 sites

  • Centre hospitalier universitaire Pellegrin

    Bordeaux, 33076

  • CHRU Brest - Hopital Cavale Blanche

    Brest, Finistère, 29609

  • CHRU Lille - Hopital Claude Huriez

    Lille, 59037

  • Hopital Européen

    Marseille, 13003

  • Hôpital de HautePierre

    Strasbourg, 67098

Other trials in France

Greece5 sites

  • Gen Hospital of Athens G Gennimatas

    Athens, Attica, 11527

  • University General Hospital of Heraklion

    Heraklion, Irakleío, 711 10

  • Regional General University Hospital of Larissa

    Larissa, 41 221

  • Kianous Stavros

    Thessaloniki, 54636

  • Gen. Hosp. of Thessaloniki "Hippokration"

    Thessaloniki, 54642

Other trials in Greece

Serbia5 sites

  • Institute of Rheumatology

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Institute for Treatment and Rehabilitation Niska Banja

    Niška Banja, 18205

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Australia4 sites

  • Optimus Clinical Research

    Botany, New South Wales, 2019

  • Emeritus Research

    Camberwell, Victoria, 3124

  • St. Vincent's Hospital

    Fitzroy, Victoria, 3065

  • The Rheumatology Research Unit Sunshine Coast

    Maroochydore, Queensland, 4558

Other trials in Australia

Italy4 sites

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126

  • Azienda Policlinico Umberto I

    Roma, 00161

  • Azienda Ospedaliera Santa Maria Della Misericordia

    Udine, 33100

Other trials in Italy

Israel3 sites

  • Carmel Hospital

    Haifa, Ḥeifā, 3436212

  • Meir Medical Center

    Kfar Saba, 4428164

  • Sheba Medical Center

    Ramat Gan, 5262000

Other trials in Israel

Austria2 sites

  • Medizinische Universität Graz

    Graz, 8036

  • A O Krankenhaus der Elisabethinen

    Linz, Upper Austria, 4020

Other trials in Austria

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

Croatia2 sites

  • Klinicki Bolnicki Centar Rijeka

    Rijeka, 51000

  • University Hospital Split

    Split, 21000

Other trials in Croatia

Netherlands2 sites

  • Vrije Universiteit Medisch Centrum Amsterdam

    Amsterdam, 1081 HV

  • Medische Centrum Leeuwarden

    Leeuwarden, Provincie Friesland, 8934 AD

Other trials in Netherlands

Switzerland1 site

  • Cantonal Hospital St.Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

About this study

Official title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).

Being tested
Baricitinib, Placebo
Keywords
SLE
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaricitinibDrug

    Also called LY3009104

    Administered orally.

  • PlaceboDrug

    Administered orally.

Study groups in NCT03843125
Study groupRoleWhat they receive
2 mg BaricitinibExperimentalParticipants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).
Receives: Drug: Baricitinib; Drug: Placebo
4 mg BaricitinibExperimentalParticipants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.
Receives: Drug: Baricitinib; Drug: Placebo
Placebo to 2 mg BaricitinibExperimentalParticipants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.
Receives: Drug: Baricitinib; Drug: Placebo
Placebo to 4 mg BaricitinibExperimentalParticipants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Receives: Drug: Baricitinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time.

    A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

    Measured: Week 134

  2. Percentage of Participants With Adverse Events of Special Interest (AESIs)

    Percentage of Participants with AESIs. AESI consisted of infections, positively adjudicated arterial thromboembolic events (ATE), positively adjudicated venous thromboembolic events (VTE), positively adjudicated major adverse cardiovascular events (MACE), other positively adjudicated cardiovascular events, death, anaphylactic reactions, hypersensitivity, angioedema, and malignancies.

    Measured: Week 134

  3. Percentage of Participants With Serious Adverse Events (SAEs)

    Percentage of participants with SAEs. An SAE is any AE from this study that results in one of the following outcomes: Death; Initial or prolonged inpatient hospitalization; A life-threatening experience (that is, immediate risk of dying); Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above.

    A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.

    Measured: Week 134

  4. Percentage of Participants With Temporary Investigational Product Interruptions

    Percentage of participants with temporary investigational product interruptions.

    Measured: Week 134

  5. Percentage of Participants With Permanent Investigational Product Discontinuations

    Percentage of participants with permanent investigational product discontinuations.

    Measured: Week 134

Secondary outcomes (9)

  1. Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response

    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 assesses disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).

    Measured: Week 134

  2. Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)

    Percentage of participants achieving a 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.

    Measured: Week 48

  3. Change From Baseline in Prednisone Dose

    Change from baseline in prednisone dose.

    Measured: Baseline through Week 48

  4. Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate

    The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. The annualized flare rate is calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25.

    Measured: Baseline through Week 48

  5. 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.

    Measured: Week 48

  6. 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.

    Measured: Baseline through Week 48

  7. 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.

    Measured: Baseline trough Week 48

  8. Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score

    The SLICC/ACR damage index is a validated instrument to assess damage, defined as irreversible impairment, continuously persistent for 6 months (ascertained by clinical assessment), occurring since the onset of lupus, and it is based on a weighted scoring system. This index records damage occurring in participants with SLE regardless of cause, with demonstrated content, face, criterion, and discriminant validity. A score of 0 indicates no damage. Total maximum score is 47 and increasing score indicates increasing disease severity.

    Measured: Baseline through Week 48

  9. Change From Baseline in Worst Pain Numeric Rating Scale (NRS)

    Change from baseline in Worst Pain NRS. It is assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". Overall severity of a patient's pain is indicated by selecting the number that best describes the worst level of pain during the past 7 days.

    Measured: Baseline through Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start9 Sep 2019
  3. Primary completion1 Apr 2022
  4. Study completion1 Apr 2022

Why it stopped: Study terminated due to insufficient evidence to support a positive benefit: risk profile. Safety findings were consistent with previously published OLUMIANT data

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03843125
Sponsor's protocol ID
16832
Other IDs
I4V-MC-JAIM, 2017-005028-11, 2017
Acronym
SLE-BRAVE-X
Status last verified
May 2023
First submitted
14 Feb 2019
Last updated
16 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baricitinib in people with Systemic Lupus Erythematosus, run by Eli Lilly and Company at 297 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 297 sites in United States, China, Japan, Russia, Mexico and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Week 134). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03843125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.

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