A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus
Study Purpose
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).
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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.
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.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03616912 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eli Lilly and Company |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
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) |
| Principal Investigator Affiliation | Eli Lilly and Company |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Australia, Austria, Belgium, Brazil, China, Croatia, Czechia, Germany, Greece, Hungary, Israel, Mexico, Netherlands, Russian Federation, Switzerland, Taiwan, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Lupus Erythematosus |
| Study Website: | View Trial Website |
Arms
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Placebo Comparator: Placebo
Placebo administered orally.
Interventions
Drug: - Baricitinib
Administered orally.
Drug: - Placebo
Administered orally.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
Status
Active, not recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Status
Completed
Address
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, 85306
Status
Completed
Address
University of Arizona
Tucson, Arizona, 85711
Status
Completed
Address
St. Joseph Heritage Medical Group
Fullerton, California, 92835
Status
Active, not recruiting
Address
MD Medical Corporation
Hemet, California, 92543
Status
Active, not recruiting
Address
ACRC Studies
Poway, California, 92064
Status
Active, not recruiting
Address
Office: Hans R Barthel M.D.
Santa Barbara, California, 93108
Status
Completed
Address
Medvin Clinical Research - Weidmann
Whittier, California, 90602
Status
Active, not recruiting
Address
Denver Arthritis Clinic - Lowry
Denver, Colorado, 80230
Status
Completed
Address
New England Research Associates
Bridgeport, Connecticut, 06606
Status
Completed
Address
Yale University School of Medicine
New Haven, Connecticut, 06519
Status
Active, not recruiting
Address
Arthritis and Rheumatic Disease
Aventura, Florida, 33180
Status
Active, not recruiting
Address
Rheumatology Associates of South Florida
Boca Raton, Florida, 33486
Status
Completed
Address
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765
Status
Completed
Address
Arthritis and Rheumatology Center of South Florida
Margate, Florida, 33063
Status
Active, not recruiting
Address
Lakes Research, LLC
Miami Lakes, Florida, 33014
Status
Active, not recruiting
Address
Millennium Research
Ormond Beach, Florida, 32174
Status
Active, not recruiting
Address
IRIS Research and Development, LLC
Plantation, Florida, 33324
Status
Completed
Address
ForCare Clinical Research
Tampa, Florida, 33613-1244
Status
Completed
Address
Piedmont Healthcare
Atlanta, Georgia, 30318
Status
Completed
Address
Atlanta Center for Clinical Research
Atlanta, Georgia, 30342
Status
Completed
Address
St Luke's Clinic - Intermountain Orthopaedics
Boise, Idaho, 83702
Status
Completed
Address
Rockford Orthopedic Associates
Rockford, Illinois, 61114
Status
Completed
Address
Henry Ford Health System
Detroit, Michigan, 48202
Status
Completed
Address
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, 48081
Status
Active, not recruiting
Address
St. Louis Rheumatology
Saint Louis, Missouri, 63119
Status
Active, not recruiting
Address
Glacier View Research Institute - Endocrinology
Kalispell, Montana, 59901
Status
Completed
Address
Allied Clinical Research
Reno, Nevada, 89519
Status
Completed
Address
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102
Status
Completed
Address
SUNY Health Science Center
Brooklyn, New York, 11203
Status
Completed
Address
St. Lawrence Health System
Canton, New York, 13617
Status
Completed
Address
Northwell Health
Great Neck, New York, 11021
Status
Active, not recruiting
Address
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
Status
Active, not recruiting
Address
Columbia University Medical Center
New York, New York, 10032
Status
Completed
Address
Buffalo Rheumatology
Orchard Park, New York, 14127
Status
Active, not recruiting
Address
Joint and Muscle Medical Care
Charlotte, North Carolina, 28204
Status
Active, not recruiting
Address
Medication Management, LLC
Greensboro, North Carolina, 27408
Status
Completed
Address
PMG Research of Wilmington
Wilmington, North Carolina, 28401
Status
Completed
Address
Cincinnati Arthritis Associates
Cincinnati, Ohio, 45242
Status
Completed
Address
The Ohio State University
Columbus, Ohio, 43210
Status
Active, not recruiting
Address
Paramount Medical Research
Middleburg Heights, Ohio, 44130
Status
Completed
Address
Arthritis & Rheumatology Center of Oklahoma PLLC
Oklahoma City, Oklahoma, 73102
Status
Completed
Address
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, 18015
Status
Completed
Address
UPMC Lupus Center of Excellence
Pittsburgh, Pennsylvania, 15213
Status
Completed
Address
West Tennessee Research Institute
Jackson, Tennessee, 38305
Status
Completed
Address
Amarillo Center for Clinical Research
Amarillo, Texas, 79124
Status
Active, not recruiting
Address
Accurate Clinical Management
Baytown, Texas, 77521
Status
Completed
Address
Dr. Dhiman Basu Private Practice
Colleyville, Texas, 76034
Status
Completed
Address
Metroplex Clinical Research Center
Dallas, Texas, 75231
Status
Active, not recruiting
Address
Precision Comprehensive Clinical Research Solutions
Fort Worth, Texas, 76107
Status
Active, not recruiting
Address
Rheumatology Center of Houston
Houston, Texas, 77004
Status
Completed
Address
Accurate Clinical Research
Houston, Texas, 77089
Status
Completed
Address
Southwest Rheumatology, P.A.
Mesquite, Texas, 75150
Status
Active, not recruiting
Address
Accurate Clinical Research, Inc.
San Antonio, Texas, 78229
Status
Completed
Address
Univ of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Status
Completed
Address
Arthritis Clinic Of Central Texas
San Marcos, Texas, 78666
Status
Active, not recruiting
Address
Spectrum Medical Inc.
Danville, Virginia, 24541
Status
Completed
Address
Swedish Medical Center
Seattle, Washington, 98122
Status
Completed
Address
Rheumatic Disease Center
Glendale, Wisconsin, 53217
International Sites
Status
Completed
Address
Emeritus Research
Botany, New South Wales, 2019
Status
Completed
Address
The Rheumatology Research Unit Sunshine Coast
Maroochydore, Queensland, 4558
Status
Completed
Address
Emeritus Research
Camberwell, Victoria, 3124
Status
Completed
Address
Monash Medical Centre
Clayton, Victoria, 3168
Status
Completed
Address
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065
Status
Completed
Address
Griffith University
Southport, , 4215
Status
Completed
Address
Ordensklinikum Linz GmbH Elisabethinen
Linz, Oberösterreich, 4020
Status
Completed
Address
Medizinische Universität Graz
Graz, , 8036
Status
Active, not recruiting
Address
Klinik Hietzing
Wien, , 1130
Status
Completed
Address
Cliniques Universitaires Saint-Luc
Bruxelles, Brussel, 1200
Status
Active, not recruiting
Address
UZ Leuven
Leuven, Vlaams Brabant, 3000
Status
Active, not recruiting
Address
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador, Bahia, 40150-150
Status
Completed
Address
CIP-Centro Internacional de Pesquisa
Goiania, Goiás, 74110-120
Status
Completed
Address
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, MG, 30150-221
Status
Completed
Address
Centro de Estudos em Terapias Inovadoras-CETI
Curitiba, Paraná, 80030-110
Status
Completed
Address
EDUMED - Educação em Saúde Ltda.
Curitiba, Paraná, 80440-080
Status
Active, not recruiting
Address
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande Do Sul, 90540-000
Status
Completed
Address
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, 90035-003
Status
Completed
Address
Hospital de Clinicas UNICAMP
Campinas, SP, 13083-970
Status
Active, not recruiting
Address
Oncovida- Centro de Onco-Hematologia de Mato Grosso
Cuiaba, , 78043-142
Status
Completed
Address
Hospital Alemao Oswaldo Cruz
Sao Paulo, , 01323-903
Status
Recruiting
Address
First affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Status
Recruiting
Address
First Affiliated Hospital of the Harbin Medical University
Harbin, Heilongjiang, 150001
Status
Recruiting
Address
The First Affiliated Hospital of Zhengzhou Universtiy
Zhengzhou, Henan, 450000
Status
Recruiting
Address
Wuhan Union Hospital
Wuhan, Hubei, 430022
Status
Recruiting
Address
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Status
Recruiting
Address
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055
Status
Recruiting
Address
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 100853
Status
Recruiting
Address
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, 200032
Status
Recruiting
Address
Tianjin Medical University General Hospital
Tianjin, Tianjin, 300052
Status
Recruiting
Address
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Status
Recruiting
Address
Ningbo First Hospital
Ningbo, Zhejiang, 315010
Status
Recruiting
Address
Peking University First Hospital
Beijing, , 100034
Status
Recruiting
Address
Beijing Peking Union Medical College Hospital
Beijing, , 100730
Status
Recruiting
Address
Shanghai Huashan Hospital Affil to Fu Dan University
Shanghai, , 200040
Status
Recruiting
Address
China Medical University (CMU) - First Affiliated Hospital
Shenyang, , 110001
Status
Recruiting
Address
The First Affliated Hospital of Soochow University
Suzhou Shi, , 215000
Status
Recruiting
Address
People's Hospital of Xinjiang Uygur Autonomous Region
Urumqi, , 830001
Status
Active, not recruiting
Address
Klinicki Bolnicki Centar Rijeka
Rijeka, , 51000
Status
Active, not recruiting
Address
University Hospital Split
Split, , 21000
Status
Active, not recruiting
Address
Clinical Hospital Dubrava
Zagreb, , 10000
Status
Active, not recruiting
Address
Revmatologicky ustav
Praha 2, Praha, Hlavní Mešto, 12850
Status
Active, not recruiting
Address
Revmatologie.s.r.o.
Brno, , 63800
Status
Completed
Address
Fakultni nemocnice Olomouc
Olomouc, , 775 20
Status
Completed
Address
ARTHROHELP s.r.o.
Pardubice, , 53002
Status
Active, not recruiting
Address
Vseobecna fakultni nemocnice
Praha 2, , 128 08
Status
Completed
Address
Universitätsklinikum Tübingen
Tubingen, Baden-Wurttemberg, 72076
Status
Active, not recruiting
Address
Universitätsklinikum Freiburg
Freiburg, Baden-Württemberg, 79106
Status
Active, not recruiting
Address
Klinikum der Universität München
München, Bayern, 80336
Status
Completed
Address
Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bayern, 97080
Status
Active, not recruiting
Address
Universitätsklinikum Köln
Köln, Nordrhein-Westfalen, 50937
Status
Completed
Address
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rheinland-Pfalz, 55131
Status
Completed
Address
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen, 01307
Status
Active, not recruiting
Address
Universität Leipzig - Universitätsklinikum
Leipzig, Sachsen, 04103
Status
Active, not recruiting
Address
Charité Universitätsmedizin Berlin Campus Buch
Berlin, , 10117
Status
Completed
Address
Immanuel Krankenhaus Rheuma Klinik Berlin Buch
Berlin, , 13125
Status
Completed
Address
Schlosspark Klinik
Berlin, , 14059
Status
Active, not recruiting
Address
Gen Hospital of Athens G Gennimatas
Athens, Attiki, 11527
Status
Active, not recruiting
Address
University General Hospital of Heraklion
Heraklion, Crete, 71110
Status
Completed
Address
University General Hospital of Larissa
Larissa, , 41110
Status
Completed
Address
Euromedica Kyanous Stavros General Hospital
Thessaloniki, , 54636
Status
Active, not recruiting
Address
Hippokration University Hopsital
Thessaloniki, , 54642
Status
Completed
Address
Bekes Megyei Pandy Kalman Korhaz
Gyula, Bekes, 5700
Status
Completed
Address
Vital Medical Center
Veszprem, Veszprém City, 8200
Status
Completed
Address
Budai Irgalmasrendi Korhaz
Budapest, , 1027
Status
Active, not recruiting
Address
Qualiclinic Kft
Budapest, , 1036
Status
Active, not recruiting
Address
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze
Budapest, , 1097
Status
Completed
Address
Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek
Debrecen, , 4032
Status
Completed
Address
Debreceni Egyetem Klinikai Kozpont
Debrecen, , 4032
Status
Active, not recruiting
Address
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, , 7632
Status
Active, not recruiting
Address
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
Szeged, , 6725
Status
Active, not recruiting
Address
Vita Verum Egeszsegugyi Szolgaltato Bt
Székesfehérvár, , 8000
Status
Completed
Address
Meir Medical Center
Kfar Saba, , 4428164
Status
Active, not recruiting
Address
Chaim Sheba Medical Center
Ramat Gan, , 5262100
Status
Active, not recruiting
Address
Carmel Hospital
Haifa, Ḥeifā, 3436212
Status
Completed
Address
CIMAB SA de CV
Torreon, Coahuila, 27000
Status
Active, not recruiting
Address
Hospital Angeles Lindavista
Mexico city, DF, 07760
Status
Completed
Address
Cliditer Sa de CV
Mexico City, Distrito Federal, 06700
Status
Active, not recruiting
Address
Morales Vargas Centro de Investigacion, S.C.
Leon, Guanajuato, 37000
Status
Active, not recruiting
Address
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, 44160
Status
Active, not recruiting
Address
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, 44650
Status
Active, not recruiting
Address
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Guadalajara, Jalisco, 44690
Status
Completed
Address
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, Jalisco, 45070
Status
Completed
Address
Köhler & Milstein Research
Merida, Yucatan, 97070
Status
Completed
Address
Centro Peninsular de Investigacion S.C.P
Merida, Yucatán, 97000
Status
Completed
Address
Cemdeicy S.C.P.
Merida, Yucatán, 97130
Status
Active, not recruiting
Address
Centro de Investigación y Tratamiento Reumatológico S.C
Ciudad De México, , 11850
Status
Active, not recruiting
Address
Clinosar Mexico S.A. de C.V
Mexico City, , 06760
Status
Active, not recruiting
Address
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.
San Luis Potosi, , 78213
Status
Active, not recruiting
Address
Medische Centrum Leeuwarden
Leeuwarden, Fryslân, 8934 AD
Status
Completed
Address
Vrije Universiteit Medisch Centrum Amsterdam
Amsterdam, , 1081 HV
Status
Completed
Address
LLC MK Med
St. Petersburg, Saint Petersburg, 197372
Status
Active, not recruiting
Address
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, , 454076
Status
Completed
Address
City Hospital # 7
Kazan, , 420103
Status
Completed
Address
Regional Clinical Hospital
Kursk, , 305007
Status
Completed
Address
Russian State Medical University
Moscow, , 117997
Status
Completed
Address
City Clinical Hospital 1 named after N.I. Pirogov
Moscow, , 119049
Status
Active, not recruiting
Address
Rheumatology Institute RAMS
Moscow, ,
Status
Active, not recruiting
Address
Healthy Family
Novosibirsk, , 630061
Status
Completed
Address
Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
Novosibirsk, , 630117
Status
Completed
Address
Regional Hospital - Omsk
Omsk, , 644111
Status
Completed
Address
Orenburg State Medical Academy of Roszdrav
Orenburg, , 460018
Status
Active, not recruiting
Address
Ryazan State Medical University
Ryazan, , 390026
Status
Completed
Address
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, , 194044
Status
Active, not recruiting
Address
Departmental Hospital at Smolensk Station "rzhd" JSC
Smolensk, , 214025
Status
Completed
Address
Kuvatov Republican Clinical Hospital
Ufa, , 450005
Status
Completed
Address
Universitätsspital Basel
Basel, Basel Stadt, 4031
Status
Active, not recruiting
Address
Cantonal Hospital St.Gallen
st.Gallen, Sankt Gallen, 9007
Status
Active, not recruiting
Address
Chang Gung Memorial Hospital - Linkou
Kuei Shan Hsiang, Taoyuan Hsien, 33305
Status
Completed
Address
Hualien Tzu-Chi Hospital
Dalin Township, , 622
Status
Completed
Address
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City, , 833401
Status
Active, not recruiting
Address
Kaohsiung Veterans General Hospital
Kaohsiung, , 81346
Status
Active, not recruiting
Address
China Medical University Hospital
Taichung, , 40447
Status
Active, not recruiting
Address
Taichung Veterans General Hospital
Taichung, , 40705
Status
Active, not recruiting
Address
Chi-Mei Medical Center
Tainan City, , 71004
Status
Active, not recruiting
Address
National Taiwan University Hospital
Taipei, , 10002
Status
Completed
Address
Taipei Medical University Hospital
Taipei, , 110
Status
Completed
Address
Maidstone Hospital
Maidstone, Kent, ME16 9QQ
Status
Completed
Address
Whipps Cross University Hospital
London, Surrey, E11 1NR
Status
Completed
Address
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, , DN2 5LT
Status
Active, not recruiting
Address
Guy's Hospital
London, , SE1 9RT
Status
Completed
Address
St. George's University Hospitals NHS Foundation Trust
London, , SW17 0QT
