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A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (BRAVE I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616912
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Baricitinib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 809 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : July 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Baricitinib

Arm Intervention/treatment
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally.
Other Name: LY3009104

Drug: Placebo
Administered orally.

Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Drug: Baricitinib
Administered orally.
Other Name: LY3009104

Drug: Placebo
Administered orally.

Placebo Comparator: Placebo
Placebo administered orally.
Drug: Placebo
Administered orally.




Primary Outcome Measures :
  1. Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (High Dose) [ Time Frame: Week 52 ]
    Percentage of participants achieving SRI-4 response (high dose).


Secondary Outcome Measures :
  1. Percentage of Participants Achieving SRI-4 Response (Low Dose) [ Time Frame: Week 52 ]
    Percentage of participants achieving SRI-4 response (low dose).

  2. Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 52 ]
    Percentage of Participants Achieving a LLDAS.

  3. Time to First Severe Flare [ Time Frame: Baseline to Week 52 ]
    Time to first severe flare.

  4. Change from Baseline in Prednisone Dose [ Time Frame: Baseline, Week 52 ]
    Change from baseline in prednisone dose.

  5. Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 52 ]
    Change from baseline in worst pain NRS.

  6. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Total Score [ Time Frame: Baseline, Week 52 ]
    Change from baseline on FACIT-Fatigue total score.

  7. 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 [ Time Frame: Week 52 ]
    Percentage of participants with CLASI total activity score ≥10 at baseline with ≥50% reduction in CLASI total activity score.

  8. Change from Baseline in Tender Joint Count [ Time Frame: Baseline, Week 52 ]
    Change from baseline in tender joint count.

  9. Change from Baseline in Swollen Joint Count [ Time Frame: Baseline, Week 52 ]
    Change from baseline in swollen joint count.

  10. Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) [ Time Frame: Baseline through Week 16 ]
    PK: Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss).

  11. Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss) [ Time Frame: Baseline through Week 16 ]
    Population PK: Maximum Observed Drug Concentration at Steady State (Cmax,ss).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616912


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
Hide Hide 184 study locations
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United States, Alabama
Achieve Clinical Research, LLC Active, not recruiting
Birmingham, Alabama, United States, 35216
University of Alabama at Birmingham Active, not recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Arthritis & Rheumatology Research, PLLC Completed
Glendale, Arizona, United States, 85306
University of Arizona Completed
Tucson, Arizona, United States, 85711
United States, California
St. Joseph Heritage Medical Group Completed
Fullerton, California, United States, 92835
MD Medical Corporation Active, not recruiting
Hemet, California, United States, 92543
ACRC Studies Active, not recruiting
Poway, California, United States, 92064
Office: Hans R Barthel M.D. Active, not recruiting
Santa Barbara, California, United States, 93108
Medvin Clinical Research - Weidmann Active, not recruiting
Whittier, California, United States, 90602
United States, Colorado
Denver Arthritis Clinic - Lowry Active, not recruiting
Denver, Colorado, United States, 80230
United States, Connecticut
New England Research Associates Completed
Bridgeport, Connecticut, United States, 06606
Yale University School of Medicine Completed
New Haven, Connecticut, United States, 06519
United States, Florida
Arthritis and Rheumatic Disease Active, not recruiting
Aventura, Florida, United States, 33180
Rheumatology Associates of South Florida Active, not recruiting
Boca Raton, Florida, United States, 33486
Clinical Research of West Florida, Inc. (Clearwater) Active, not recruiting
Clearwater, Florida, United States, 33765
Arthritis and Rheumatology Center of South Florida Active, not recruiting
Margate, Florida, United States, 33063
Lakes Research, LLC Active, not recruiting
Miami Lakes, Florida, United States, 33014
Millennium Research Active, not recruiting
Ormond Beach, Florida, United States, 32174
IRIS Research and Development, LLC Active, not recruiting
Plantation, Florida, United States, 33324
ForCare Clinical Research Active, not recruiting
Tampa, Florida, United States, 33613-1244
United States, Georgia
Piedmont Healthcare Active, not recruiting
Atlanta, Georgia, United States, 30318
Atlanta Center for Clinical Research Completed
Atlanta, Georgia, United States, 30342
United States, Idaho
St Luke's Clinic - Intermountain Orthopaedics Completed
Boise, Idaho, United States, 83702
United States, Illinois
Rockford Orthopedic Associates Completed
Rockford, Illinois, United States, 61114
United States, Michigan
Henry Ford Health System Completed
Detroit, Michigan, United States, 48202
Clinical Research Institute of Michigan, LLC Active, not recruiting
Saint Clair Shores, Michigan, United States, 48081
United States, Missouri
St. Louis Rheumatology Active, not recruiting
Saint Louis, Missouri, United States, 63119
United States, Montana
Glacier View Research Institute - Endocrinology Active, not recruiting
Kalispell, Montana, United States, 59901
United States, Nevada
Allied Clinical Research Completed
Reno, Nevada, United States, 89519
United States, New Mexico
Albuquerque Center for Rheumatology Completed
Albuquerque, New Mexico, United States, 87102
United States, New York
SUNY Health Science Center Active, not recruiting
Brooklyn, New York, United States, 11203
St. Lawrence Health System Completed
Canton, New York, United States, 13617
Northwell Health Completed
Great Neck, New York, United States, 11021
The Feinstein Institute for Medical Research Active, not recruiting
Manhasset, New York, United States, 11030
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Buffalo Rheumatology Active, not recruiting
Orchard Park, New York, United States, 14127
United States, North Carolina
Joint and Muscle Medical Care Active, not recruiting
Charlotte, North Carolina, United States, 28204
Medication Management, LLC Active, not recruiting
Greensboro, North Carolina, United States, 27408
PMG Research of Wilmington Active, not recruiting
Wilmington, North Carolina, United States, 28401
United States, Ohio
Cincinnati Arthritis Associates Completed
Cincinnati, Ohio, United States, 45242
The Ohio State University Completed
Columbus, Ohio, United States, 43210
Paramount Medical Research Active, not recruiting
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma PLLC Active, not recruiting
Oklahoma City, Oklahoma, United States, 73102
United States, Pennsylvania
East Penn Rheumatology Associates Active, not recruiting
Bethlehem, Pennsylvania, United States, 18015
UPMC Lupus Center of Excellence Completed
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
West Tennessee Research Institute Active, not recruiting
Jackson, Tennessee, United States, 38305
United States, Texas
Amarillo Center for Clinical Research Active, not recruiting
Amarillo, Texas, United States, 79124
Accurate Clinical Management Active, not recruiting
Baytown, Texas, United States, 77521
Dr. Dhiman Basu Private Practice Completed
Colleyville, Texas, United States, 76034
Metroplex Clinical Research Center Completed
Dallas, Texas, United States, 75231
Precision Comprehensive Clinical Research Solutions Active, not recruiting
Fort Worth, Texas, United States, 76107
Rheumatology Center of Houston Active, not recruiting
Houston, Texas, United States, 77004
Accurate Clinical Research Active, not recruiting
Houston, Texas, United States, 77089
Southwest Rheumatology, P.A. Active, not recruiting
Mesquite, Texas, United States, 75150
Accurate Clinical Research, Inc. Active, not recruiting
San Antonio, Texas, United States, 78229
Univ of Texas Health Science Center at San Antonio Completed
San Antonio, Texas, United States, 78229
Arthritis Clinic Of Central Texas Completed
San Marcos, Texas, United States, 78666
United States, Virginia
Spectrum Medical Inc. Active, not recruiting
Danville, Virginia, United States, 24541
United States, Washington
Swedish Medical Center Completed
Seattle, Washington, United States, 98122
United States, Wisconsin
Rheumatic Disease Center Active, not recruiting
Glendale, Wisconsin, United States, 53217
Australia, New South Wales
Emeritus Research Active, not recruiting
Botany, New South Wales, Australia, 2019
Australia, Queensland
The Rheumatology Research Unit Sunshine Coast Active, not recruiting
Maroochydore, Queensland, Australia, 4558
Australia, Victoria
Emeritus Research Active, not recruiting
Camberwell, Victoria, Australia, 3124
Monash Medical Centre Completed
Clayton, Victoria, Australia, 3168
St Vincents Hospital Melbourne Active, not recruiting
Fitzroy, Victoria, Australia, 3065
Australia
Griffith University Active, not recruiting
Southport, Australia, 4215
Austria
Ordensklinikum Linz GmbH Elisabethinen Active, not recruiting
Linz, Oberösterreich, Austria, 4020
Medizinische Universität Graz Active, not recruiting
Graz, Austria, 8036
Klinik Hietzing Active, not recruiting
Wien, Austria, 1130
Belgium
Cliniques Universitaires Saint-Luc Completed
Bruxelles, Brussel, Belgium, 1200
UZ Leuven Active, not recruiting
Leuven, Vlaams Brabant, Belgium, 3000
CHU de Liège Completed
Liège, Belgium, 4000
Brazil
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME Active, not recruiting
Salvador, Bahia, Brazil, 40150-150
CIP-Centro Internacional de Pesquisa Active, not recruiting
Goiania, Goiás, Brazil, 74110-120
Santa Casa de Misericordia de Belo Horizonte Active, not recruiting
Belo Horizonte, MG, Brazil, 30150-221
Centro de Estudos em Terapias Inovadoras-CETI Active, not recruiting
Curitiba, Paraná, Brazil, 80030-110
EDUMED - Educação em Saúde Ltda. Active, not recruiting
Curitiba, Paraná, Brazil, 80440-080
LMK Serviços Médicos S/S Active, not recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90540-000
Hospital de Clinicas de Porto Alegre Completed
Porto Alegre, RS, Brazil, 90035-003
Hospital de Clinicas UNICAMP Active, not recruiting
Campinas, SP, Brazil, 13083-970
Oncovida- Centro de Onco-Hematologia de Mato Grosso Active, not recruiting
Cuiaba, Brazil, 78043-142
Hospital Alemao Oswaldo Cruz Active, not recruiting
Sao Paulo, Brazil, 01323-903
China, Guangdong
First affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact    862087332200      
Principal Investigator: Niansheng Yang         
China, Heilongjiang
First Affiliated Hospital of the Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact    8645113804601998      
Principal Investigator: Zhiyi Zhang         
China, Henan
The First Affiliated Hospital of Zhengzhou Universtiy Recruiting
Zhengzhou, Henan, China, 450000
Contact    +8613837192659      
Principal Investigator: Shengyun Liu         
China, Hubei
Wuhan Union Hospital Recruiting
Wuhan, Hubei, China, 430022
Contact    862785726136      
Principal Investigator: Anbin Huang         
China, Jiangsu
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210000
Contact    8613817544696      
Principal Investigator: Lingyun Sun         
China, Jiangxi
Jiangxi Pingxiang People's Hospital Recruiting
Pingxiang, Jiangxi, China, 337055
Contact    8613879936380      
Principal Investigator: Jiankang Hu         
China, Jilin
China-Japan Union Hospital of Jilin University Recruiting
Changchun, Jilin, China, 100853
Contact    8603578879099      
Principal Investigator: LiQi Bi         
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact    8613701973875      
Principal Investigator: Lindi Di Jiang         
China, Tianjin
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300052
Contact    8613920182411      
Principal Investigator: Wei Wei         
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact    05717783858      
Principal Investigator: Hua-Xiang Wu         
Ningbo First Hospital Recruiting
Ningbo, Zhejiang, China, 315010
Contact    86138 5782 6442      
Principal Investigator: Xiudi Wu         
China
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact    8613301152845      
Principal Investigator: Zhuoli Zhang         
Beijing Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact    8613501069845      
Principal Investigator: Xiaofeng Zeng         
Shanghai Huashan Hospital Affil to Fu Dan University Recruiting
Shanghai, China, 200040
Contact    8613817544696      
Principal Investigator: Wei-Guo Wan         
China Medical University (CMU) - First Affiliated Hospital Recruiting
Shenyang, China, 110001
Contact    8613840523456      
Principal Investigator: Rong Zhang         
The First Affliated Hospital of Soochow University Recruiting
Suzhou Shi, China, 215000
Contact    86051265223637      
Principal Investigator: Jian Wu         
People's Hospital of Xinjiang Uygur Autonomous Region Recruiting
Urumqi, China, 830001
Contact    8613999265917      
Principal Investigator: Li-Jun Wu         
Croatia
Klinicki Bolnicki Centar Rijeka Active, not recruiting
Rijeka, Croatia, 51000
University Hospital Split Active, not recruiting
Split, Croatia, 21000
Clinical Hospital Dubrava Active, not recruiting
Zagreb, Croatia, 10000
Czechia
Revmatologicky ustav Active, not recruiting
Praha 2, Praha, Hlavní Mešto, Czechia, 12850
Revmatologie.s.r.o. Active, not recruiting
Brno, Czechia, 63800
Fakultni nemocnice Olomouc Completed
Olomouc, Czechia, 775 20
ARTHROHELP s.r.o. Active, not recruiting
Pardubice, Czechia, 53002
Vseobecna fakultni nemocnice Active, not recruiting
Praha 2, Czechia, 128 08
Germany
Universitätsklinikum Tübingen Active, not recruiting
Tubingen, Baden-Wurttemberg, Germany, 72076
Universitätsklinikum Freiburg Active, not recruiting
Freiburg, Baden-Württemberg, Germany, 79106
Klinikum der Universität München Active, not recruiting
München, Bayern, Germany, 80336
Universitätsklinikum Würzburg A. ö. R. Active, not recruiting
Würzburg, Bayern, Germany, 97080
Universitätsklinikum Köln Active, not recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Active, not recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Universitätsklinikum Carl Gustav Carus Active, not recruiting
Dresden, Sachsen, Germany, 01307
Universität Leipzig - Universitätsklinikum Active, not recruiting
Leipzig, Sachsen, Germany, 04103
Charité Universitätsmedizin Berlin Campus Buch Active, not recruiting
Berlin, Germany, 10117
Immanuel Krankenhaus Rheuma Klinik Berlin Buch Completed
Berlin, Germany, 13125
Schlosspark Klinik Active, not recruiting
Berlin, Germany, 14059
Greece
Gen Hospital of Athens G Gennimatas Active, not recruiting
Athens, Attiki, Greece, 11527
University General Hospital of Heraklion Active, not recruiting
Heraklion, Crete, Greece, 71110
University General Hospital of Larissa Active, not recruiting
Larissa, Greece, 41110
Euromedica Kyanous Stavros General Hospital Active, not recruiting
Thessaloniki, Greece, 54636
Hippokration University Hopsital Active, not recruiting
Thessaloniki, Greece, 54642
Hungary
Bekes Megyei Pandy Kalman Korhaz Active, not recruiting
Gyula, Bekes, Hungary, 5700
Vital Medical Center Completed
Veszprem, Veszprém City, Hungary, 8200
Budai Irgalmasrendi Korhaz Active, not recruiting
Budapest, Hungary, 1027
Qualiclinic Kft Active, not recruiting
Budapest, Hungary, 1036
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze Active, not recruiting
Budapest, Hungary, 1097
Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek Active, not recruiting
Debrecen, Hungary, 4032
Debreceni Egyetem Klinikai Kozpont Active, not recruiting
Debrecen, Hungary, 4032
Pecsi Tudomanyegyetem Klinikai Kozpont Active, not recruiting
Pecs, Hungary, 7632
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika Active, not recruiting
Szeged, Hungary, 6725
Vita Verum Egeszsegugyi Szolgaltato Bt Active, not recruiting
Székesfehérvár, Hungary, 8000
Israel
Meir Medical Center Active, not recruiting
Kfar Saba, Israel, 4428164
Chaim Sheba Medical Center Active, not recruiting
Ramat Gan, Israel, 5262100
Carmel Hospital Active, not recruiting
Haifa, Ḥeifā, Israel, 3436212
Mexico
CIMAB SA de CV Active, not recruiting
Torreon, Coahuila, Mexico, 27000
Hospital Angeles Lindavista Active, not recruiting
Mexico city, DF, Mexico, 07760
Cliditer Sa de CV Active, not recruiting
Mexico City, Distrito Federal, Mexico, 06700
Morales Vargas Centro de Investigacion, S.C. Active, not recruiting
Leon, Guanajuato, Mexico, 37000
Centro Integral en Reumatologia SA de CV Active, not recruiting
Guadalajara, Jalisco, Mexico, 44160
Clinica de Investigacion en Reumatologia y Obesidad S. C. Active, not recruiting
Guadalajara, Jalisco, Mexico, 44650
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares Active, not recruiting
Guadalajara, Jalisco, Mexico, 44690
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. Active, not recruiting
Zapopan, Jalisco, Mexico, 45070
Köhler & Milstein Research Active, not recruiting
Merida, Yucatan, Mexico, 97070
Centro Peninsular de Investigacion S.C.P Active, not recruiting
Merida, Yucatán, Mexico, 97000
Cemdeicy S.C.P. Active, not recruiting
Merida, Yucatán, Mexico, 97130
Centro de Investigación y Tratamiento Reumatológico S.C Active, not recruiting
Ciudad De México, Mexico, 11850
Clinosar Mexico S.A. de C.V Active, not recruiting
Mexico City, Mexico, 06760
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C. Active, not recruiting
San Luis Potosi, Mexico, 78213
Netherlands
Medische Centrum Leeuwarden Active, not recruiting
Leeuwarden, Fryslân, Netherlands, 8934 AD
Vrije Universiteit Medisch Centrum Amsterdam Active, not recruiting
Amsterdam, Netherlands, 1081 HV
Russian Federation
LLC MK Med Active, not recruiting
St. Petersburg, Saint Petersburg, Russian Federation, 197372
Chelyabinsk Regional Clinical Hospital Active, not recruiting
Chelyabinsk, Russian Federation, 454076
City Hospital # 7 Active, not recruiting
Kazan, Russian Federation, 420103
Regional Clinical Hospital Active, not recruiting
Kursk, Russian Federation, 305007
Russian State Medical University Active, not recruiting
Moscow, Russian Federation, 117997
City Clinical Hospital 1 named after N.I. Pirogov Completed
Moscow, Russian Federation, 119049
Rheumatology Institute RAMS Active, not recruiting
Moscow, Russian Federation
Healthy Family Active, not recruiting
Novosibirsk, Russian Federation, 630061
Reafan Active, not recruiting
Novosibirsk, Russian Federation, 630099
Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences Completed
Novosibirsk, Russian Federation, 630117
Regional Hospital - Omsk Active, not recruiting
Omsk, Russian Federation, 644111
Orenburg State Medical Academy of Roszdrav Active, not recruiting
Orenburg, Russian Federation, 460018
Ryazan State Medical University Active, not recruiting
Ryazan, Russian Federation, 390026
Russian Medical Military Academy n.a. S.M. Kirov Active, not recruiting
Saint Petersburg, Russian Federation, 194044
Departmental Hospital at Smolensk Station "rzhd" JSC Active, not recruiting
Smolensk, Russian Federation, 214025
Kuvatov Republican Clinical Hospital Active, not recruiting
Ufa, Russian Federation, 450005
Switzerland
Universitätsspital Basel Completed
Basel, Basel Stadt, Switzerland, 4031
Cantonal Hospital St.Gallen Active, not recruiting
st.Gallen, Sankt Gallen, Switzerland, 9007
Taiwan
Chang Gung Memorial Hospital - Linkou Active, not recruiting
Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 33305
Hualien Tzu-Chi Hospital Completed
Dalin Township, Taiwan, 622
Chang Gung Memorial Hospital - Kaohsiung Branch Active, not recruiting
Kaohsiung City, Taiwan, 833401
Kaohsiung Veterans General Hospital Active, not recruiting
Kaohsiung, Taiwan, 81346
China Medical University Hospital Active, not recruiting
Taichung, Taiwan, 40447
Taichung Veterans General Hospital Active, not recruiting
Taichung, Taiwan, 40705
Chi-Mei Medical Center Active, not recruiting
Tainan City, Taiwan, 71004
National Taiwan University Hospital Active, not recruiting
Taipei, Taiwan, 10002
Taipei Medical University Hospital Active, not recruiting
Taipei, Taiwan, 110
United Kingdom
Maidstone Hospital Completed
Maidstone, Kent, United Kingdom, ME16 9QQ
Whipps Cross University Hospital Completed
London, Surrey, United Kingdom, E11 1NR
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust Active, not recruiting
Doncaster, United Kingdom, DN2 5LT
Guy's Hospital Active, not recruiting
London, United Kingdom, SE1 9RT
St. George's University Hospitals NHS Foundation Trust Completed
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
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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
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03616912    
Other Study ID Numbers: 16676
I4V-MC-JAHZ ( Other Identifier: Eli Lilly and Company )
2017-005026-37 ( EudraCT Number )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
SLE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases