Study Stopped
Study terminated due to insufficient evidence to support a positive benefit: risk profile. Safety findings were consistent with previously published OLUMIANT data
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
SLE-BRAVE-X
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
3 other identifiers
interventional
1,147
31 countries
295
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2019
Typical duration for phase_3
295 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedResults Posted
Study results publicly available
May 16, 2023
CompletedMay 16, 2023
May 1, 2023
2.6 years
February 14, 2019
March 30, 2023
May 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
Week 134
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.
Week 134
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.
Week 134
Percentage of Participants With Temporary Investigational Product Interruptions
Percentage of participants with temporary investigational product interruptions.
Week 134
Percentage of Participants With Permanent Investigational Product Discontinuations
Percentage of participants with permanent investigational product discontinuations.
Week 134
Secondary Outcomes (9)
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response
Week 134
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
Week 48
Change From Baseline in Prednisone Dose
Baseline through Week 48
Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate
Baseline through Week 48
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
Week 48
- +4 more secondary outcomes
Study Arms (4)
2 mg Baricitinib
EXPERIMENTALParticipants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).
4 mg Baricitinib
EXPERIMENTALParticipants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.
Placebo to 2 mg Baricitinib
EXPERIMENTALParticipants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.
Placebo to 4 mg Baricitinib
EXPERIMENTALParticipants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
Interventions
Administered orally.
Administered orally.
Eligibility Criteria
You may qualify if:
- Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Incyte Corporationcollaborator
Study Sites (297)
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85032, United States
Arizona Arthritis & Rheumatology Associates, P. C.
Tucson, Arizona, 85704, United States
Wallace Rheumatic Studies Center
Beverly Hills, California, 90211, United States
Medvin Clinical Research - Weidmann
Covina, California, 91722, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
MD Medical Corporation
Hemet, California, 92543, United States
ACRC Studies
Poway, California, 92064, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, 91786, United States
Medvin Clinical Research - Weidmann
Whittier, California, 90602, United States
Denver Arthritis Clinic - Lowry
Denver, Colorado, 80230, United States
New England Research Associates
Bridgeport, Connecticut, 06606, United States
Arthritis and Rheumatic Disease
Aventura, Florida, 33180, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765, United States
Lakes Research, LLC
Miami Lakes, Florida, 33014, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324, United States
IRIS Research and Development, LLC
Plantation, Florida, 33324, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614, United States
Piedmont Healthcare
Atlanta, Georgia, 30318, United States
Emory University
Atlanta, Georgia, 30322, United States
North Georgia Rheumatology, PC
Lawrenceville, Georgia, 30046, United States
Arthritis Center of Lexington
Lexington, Kentucky, 40504, United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Advanced Rheumatology, PC
Lansing, Michigan, 48910, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, 48081, United States
Glacir View Research Institute
Kalispell, Montana, 59901, United States
Allied Clinical Research
Reno, Nevada, 89519, United States
Arthritis and Osteoporosis Associates of New Mexico
Las Cruces, New Mexico, 88011, United States
St. Lawrence Health System
Canton, New York, 13617, United States
The Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
Columbia University Medical Center
New York, New York, 10032, United States
NYU Langone
New York, New York, 11201, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Joint and Muscle Medical Care
Charlotte, North Carolina, 28204, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte, North Carolina, 28210, United States
Medication Management
Greensboro, North Carolina, 27408, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, 45242, United States
Paramount Medical Research
Middleburg Heights, Ohio, 44130, United States
Arthritis & Rheumatology Center of Oklahoma PLLC
Oklahoma City, Oklahoma, 73102, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104-5046, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, 18015, United States
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, 19610, United States
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
Summerville, South Carolina, 29486, United States
Eagle Medical
Crossville, Tennessee, 38555, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124, United States
Accurate Clinical Management
Baytown, Texas, 77521, United States
Dr. Dhiman Basu Private Practice
Colleyville, Texas, 76034, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Precision Comprehensive Clinical Research Solutions
Fort Worth, Texas, 76107, United States
Rheumatology Center Of Houston
Houston, Texas, 77004, United States
Accurate Clinical Research
Houston, Texas, 77089, United States
Southwest Rheumatology, P.A.
Mesquite, Texas, 75150, United States
Accurate Clinical Research, Inc.
San Antonio, Texas, 78229, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382, United States
Arthritis Clinic of Northern VA, P.C.
Arlington, Virginia, 22205, United States
Spectrum Medical Inc.
Danville, Virginia, 24541, United States
Rheumatic Disease Center
Glendale, Wisconsin, 53217, United States
Aprillus Asistencia e Investigacion de Arcis Salud SRL
Ciudad Autónoma de Buenos Aire, Buenos Aires, 1046, Argentina
DOM Centro de Reumatologia
Ciudad de Buenos Aires, Buenos Aires, C1111AAH, Argentina
Framingham Centro Medico
La Plata, Buenos Aires, B1902COS, Argentina
CER Instituto Medico
Quilmes, Buenos Aires, B1878DVC, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, B1878GEG, Argentina
Clinica Adventista Belgrano
CABA, Ciudad Autónoma de Buenos Aire, C1430EGF, Argentina
Sanatorio Británico
Rosario, Santa Fe Province, 2000, Argentina
Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO, Argentina
IR Medical Center S.A. Instituto de Reumatologia
Mendoza, M5500CPH, Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucumán, T4000AXL, Argentina
Optimus Clinical Research
Botany, New South Wales, 2019, Australia
The Rheumatology Research Unit Sunshine Coast
Maroochydore, Queensland, 4558, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
St. Vincent's Hospital
Fitzroy, Victoria, 3065, Australia
A O Krankenhaus der Elisabethinen
Linz, Upper Austria, 4020, Austria
Medizinische Universität Graz
Graz, 8036, Austria
UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Estado de Bahia, 40150-150, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Centro de Estudos em Terapias Inovadoras-CETI
Curitiba, Paraná, 80030-110, Brazil
EDUMED - Educação em Saúde Ltda.
Curitiba, Paraná, 80440-080, Brazil
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande do Sul, 90540-000, Brazil
Hospital de Clinicas UNICAMP
Campinas, São Paulo, 13083-970, Brazil
Oncovida- Centro de Onco-Hematologia de Mato Grosso
Cuiabá, 78043-142, Brazil
Clinical Research Chile SpA
Valdivia, Los Ríos Region, 5110683, Chile
Enroll SpA
Providencia, Región Metropolitana de Santia, 7500587, Chile
Clinica Alemana de Osorno
Osorno, 5290000, Chile
Sociedad Medica Del Aparato Locomotor SA
Santiago, 7510186, Chile
Prosalud y cia. Ltda.
Santiago, Chile
CINVEC- Estudos Clínicos Quinta Región Limitada
Viña del Mar, 2570017, Chile
The First Affliated Hospital of Suzhou University
Suzhou, China, 215000, China
First affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
First Affiliated Hospital of the Harbin Medical University
Harbin, Heilongjiang, 150001, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000, China
China-Japan Union Hospital, CJUH.
Changchun, Jilin, 130033, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
Peking University First Hospital
Beijing, 100034, China
Beijing Peking Union Medical College Hospital
Beijing, 100730, China
Shanghai Huashan Hospital Affil to Fu Dan University
Shanghai, 200040, China
China Medical University (CMU) - First Affiliated Hospital
Shenyang, 110001, China
The First Affiliated Hospital of Zhengzhou Universtiy
Zhengzhou, 450000, China
HPTU-El Hospital con alma Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Clinica de la Costa
Barranquilla, Atlántico, 080020, Colombia
Circaribe SAS
Barranquilla, Atlántico, Colombia
Idearg S.A.S.
Bogota, Cundinamarca, Colombia
Servimed S.A.S.
Bucaramanga, Santander Department, 12345, Colombia
Centro de Medicina Interna
Cali, Valle del Cauca Department, Colombia
Preventive Care Ltdac
Chía, Colombia
Klinicki Bolnicki Centar Rijeka
Rijeka, 51000, Croatia
University Hospital Split
Split, 21000, Croatia
Revmatologicky ustav
Prague, Praha, Hlavní Mešto, 12850, Czechia
Revmatologie.s.r.o.
Brno, 638 00, Czechia
Fakultni nemocnice Olomouc
Olomouc, 775 20, Czechia
ARTHROHELP s.r.o.
Pardubice, 53002, Czechia
VFN a 1 LF University Karlovy
Prague, 128 08, Czechia
CHRU Brest - Hopital Cavale Blanche
Brest, Finistère, 29609, France
Centre hospitalier universitaire Pellegrin
Bordeaux, 33076, France
CHRU Lille - Hopital Claude Huriez
Lille, 59037, France
Hopital Européen
Marseille, 13003, France
Hôpital de HautePierre
Strasbourg, 67098, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Klinikum der Universität München Großhadern
München, Bavaria, 81337, Germany
Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bavaria, 97080, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, 4103, Germany
Charité Campus Virchow-Klinikum
Berlin, 10117, Germany
Immanuel Krankenhaus Rheuma Klinik Berlin Buch
Berlin, 13125, Germany
Schlosspark Klinik
Berlin, 14059, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Gen Hospital of Athens G Gennimatas
Athens, Attica, 11527, Greece
University General Hospital of Heraklion
Heraklion, Irakleío, 711 10, Greece
Regional General University Hospital of Larissa
Larissa, 41 221, Greece
Kianous Stavros
Thessaloniki, 54636, Greece
Gen. Hosp. of Thessaloniki "Hippokration"
Thessaloniki, 54642, Greece
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
Gyula, Bekes County, 5700, Hungary
Vital Medical Center
Veszprém, Veszprém City, 8200, Hungary
Budai Irgalmasrendi Korhaz
Budapest, 1023, Hungary
Qualiclinic
Budapest, 1036, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097, Hungary
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
Debrecen, 4004, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7632, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
Szeged, 6725, Hungary
Vita Verum Egeszsegugyi Szolgaltato Bt
Székesfehérvár, 8000, Hungary
Panchshil hospital
Ahmedabad, Gujarat, 380005, India
CIMS Hospital Private Limited
Ahmedabad, Gujarat, 380060, India
Shree Giriraj Hospital
Rajkot, Gujarat, 360004, India
Nirmal Hospital Private Limited
Surat, Gujarat, 395002, India
Sterling Hospital
Vadodara, Gujarat, 390007, India
ChanRe Rheumatology And Immunology Center And Research
Bangalore, Karnataka, 560010, India
St. John Medical College & Hospital
Bangalore, Karnataka, 560034, India
Sushruta Multispecialty Hospital & Research Center Pvt Ltd
Hubli, Karnataka, 580021, India
Kasturba Medical College Hospital, Mangalore
Madhav Nagar, Manipal, Karnataka, 576104, India
Jasleen Hospital
Nagpur, Maharashtra, 440012, India
Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
Nashik, Maharashtra, 422101, India
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017, India
Krishna Institute of Medical Science
Secunderabad, Telangana, 500003, India
Meir Medical Center
Kfar Saba, 4428164, Israel
Sheba Medical Center
Ramat Gan, 5262000, Israel
Carmel Hospital
Haifa, Ḥeifā, 3436212, Israel
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56126, Italy
Azienda Policlinico Umberto I
Roma, 00161, Italy
Azienda Ospedaliera Santa Maria Della Misericordia
Udine, 33100, Italy
University of Occupational and Enviromental Health
Kitakyushu, Fukuoka, 807-8556, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 070-8644, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Jp Red Cross Society Himeji Hp
Himeji, Hyōgo, 670-8540, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Tomishiro Central Hospital
Tomigusuku, Okinawa, 901-0243, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, 430-8558, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, 113-8603, Japan
Showa University Hospital
Shinagawa, Tokyo, 142-8555, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810 8563, Japan
Hamanomachi Hospital
Fukuoka, 810-8539, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
St. Luke's International Hospital
Tokyo, 104-8560, Japan
Keio university hospital
Tokyo, 1600035, Japan
Dr. Alberto Esteban Bazzoni Ruiz
Torreón, Coahuila, 27000, Mexico
Morales Vargas Centro de Investigacion, S.C.
León, Guanajuato, 37000, Mexico
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, 44160, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, 44650, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Guadalajara, Jalisco, 44690, Mexico
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, Jalisco, 45030, Mexico
Clinica para el Diagnostico y Tratamiento de la Enfermedades
Mexico City, Mexico City, 06700, Mexico
Centro de Alta Especialidad Reumatologia Inv del Potosi SC
San Luis Potosí City, San Luis Potosí, 78213, Mexico
Consultorio Jose Luis Garcia Figueroa
Villahermosa, Tabasco, 89190, Mexico
Centro Peninsular de Investigacion S.C.P
Mérida, Yucatán, 97000, Mexico
Köhler & Milstein Research
Mérida, Yucatán, 97070, Mexico
Cemdeicy S.C.P.
Mérida, Yucatán, 97130, Mexico
Clinosar Mexico S.A. de C.V
Mexico City, 06760, Mexico
Consultorio de Reumatologia
Mexico City, 07760, Mexico
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, 11850, Mexico
Oaxaca Site Management Organization
Oaxaca City, 68000, Mexico
Medische Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
Vrije Universiteit Medisch Centrum Amsterdam
Amsterdam, 1081 HV, Netherlands
Mary Mediatrix Medical Center
Lipa, Batangas, 4217, Philippines
Cebu Doctors Hospital
Cebu City, Cebu, 6000, Philippines
Chong Hua Hospital
Cebu City, Cebu, 6000, Philippines
Southern Philippines Medical Center
Davao City, Davao Del Norte, 8000, Philippines
Makati Medical Center
Makati, Luzon, 1229, Philippines
St. Luke's Medical Center
Quezon City, Luzon, 1102, Philippines
Angeles University Foundation and Medical Center
Angeles City, Pampanga, 2009, Philippines
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
Wroclaw, Lower Silesian Voivodeship, 53224, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
Medycyna Kliniczna
Warsaw, Masovian Voivodeship, 00874, Poland
Reumatika - Centrum Reumatologii
Warsaw, Masovian Voivodeship, 02-691, Poland
Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
Bialystok, Podlaskie Voivodeship, 15-077, Poland
Zespol Poradni Specjalistycznych REUMED
Lublin, Polska, 20582, Poland
Ambulatorium Barbara Bazela
Elblag, Warminsko-Mazurki, 82300, Poland
Centrum Medyczne Pratia Katowice
Katowice, 40-081, Poland
MCM Krakow - PRATIA - PPDS
Krakow, 30-510, Poland
Centrum Medyczne Plejady
Krakow, 30363, Poland
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, 05-830, Poland
Klinika Reumatologii i Rehabilitacji
Poznan, 61-545, Poland
Klinika Reumatologii, Chorob Wewnetrznych i Geriatrii PUM
Szczecin, 71-252, Poland
Centrum Medyczne AMED
Warsaw, 03-291, Poland
C.M.D.T.A. Neomed
Brasov, Brașov County, 500283, Romania
Spitalul Euroclinic
Bucureti, București, 14461, Romania
Napoca Emergency Clinical County Hospital
Cluj-Napoca, Cluj, 40006, Romania
Craiova Emergency Clinical County Hospital
Craiova, Dolj, 200642, Romania
Spitalul Clinic Sf Maria Bucuresti
Bucharest, 011172, Romania
Spitalul Clinic "Dr. Ioan Cantacuzino"
Bucharest, 020475, Romania
SANA Medical Center
Bucharest, 11025, Romania
Moscow City Clinical Hospital Number 52
Moscow, Moscow, Russia
Russian National Research Medical University n.a. N.I.Pirogov
Moscow, Russian Federation, 117997, Russia
LLC MK Med
Saint Petersburg, Sankt-Peterburg, 197372, Russia
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, 454076, Russia
City Hospital # 7
Kazan', 420103, Russia
V.A. Nasonova Research Institute of Rheumatology
Moscow, 115522, Russia
City Clinical Hospital 1 named after N.I. Pirogov
Moscow, 119049, Russia
Research Institute of Clinical Immunology
Novosibirsk, 630099, Russia
Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
Novosibirsk, 630117, Russia
Regional Hospital - Omsk
Omsk, 644111, Russia
Orenburg State Medical Academy of Roszdrav
Orenburg, 460018, Russia
Kursk Regional Clinical Hospital
Rursk, 305007, Russia
Ryazan State Medical University
Ryazan, 390026, Russia
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, 194044, Russia
Departmental Hospital at Smolensk Station "rzhd" JSC
Smolensk, 214025, Russia
Kuvatov Republican Clinical Hospital
Ufa, 450005, Russia
LLC Medical Center Zdorovaya Semiya
Zonova, 630061, Russia
Institute of Rheumatology
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, 18205, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
Suite 509 Umhlanga Netcare Medical Centre
Umhlanga, Durban, 4319, South Africa
WITS Clinical Research
Johannesburg, Gauteng, 2193, South Africa
Jakaranda Hospital
Pretoria, Gauteng, 0002, South Africa
Vincent Pallotti Hospital
Cape Town, Western Cape, 7405, South Africa
Panorama Medical Centre
Cape Town, Western Cape, 7500, South Africa
Winelands Medical Research Centre
Stellenbosch, Western Cape, 7600, South Africa
University Of Pretoria
Pretoria, 0002, South Africa
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Kyung Pook National University Hospital
Daegu, Korea, 41944, South Korea
Chungnam National University Hospital
Daejeon, Korea, 35015, South Korea
Gachon University Gil Hospital
Incheon, Korea, 21565, South Korea
Hanyang University Medical Center
Seoul, Korea, 04763, South Korea
Asan Medical Center
Seoul, Korea, 05505, South Korea
Seoul St. Mary's Hospital
Seoul, Korea, 06591, South Korea
Hospital Marina Baixa
Villajoyosa, Alicante, 03570, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 8035, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital De Fuenlabrada
Fuenlabrada, Madrid, 28944, Spain
Hospital do Meixoeiro
Vigo, Pontevedra, 36200, Spain
Corporació Sanitària Clínic
Barcelona, 8036, Spain
Hospital Quiron Infanta Luisa
Seville, 41010, Spain
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Hualien Tzu-Chi Hospital
Dalin Township, 622, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, 83301, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Chi-Mei Medical Center
Tainan, 71004, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, 33305, Taiwan
Maidstone Hospital
Maidstone, Kent, ME16 9QQ, United Kingdom
Whipps Cross University Hospital
Leytonstone, London, E11 1NR, United Kingdom
St George's Hospital
Tooting, London, SW17 0QT, United Kingdom
Guys/St. Thomas Hospital
London, Surrey, SE1 9RT, United Kingdom
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, DN2 5LT, United Kingdom
Leeds Teaching Hospital
Leeds, LS7 4SA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated due to insufficient evidence to support a positive benefit: risk profile. Safety findings were consistent with previously published OLUMIANT data.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2019
First Posted
February 15, 2019
Study Start
September 9, 2019
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
May 16, 2023
Results First Posted
May 16, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.