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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 : June 4, 2020
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 : 750 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 : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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 180 study locations
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United States, Alabama
Achieve Clinical Research, LLC Recruiting
Birmingham, Alabama, United States, 35216
Contact    205-757-8212      
Principal Investigator: Hayes T Williams         
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact    2059347754      
Principal Investigator: Walter Winn Chatham         
United States, Arizona
Arizona Arthritis & Rheumatology Research Recruiting
Glendale, Arizona, United States, 85306
Contact    480-626-6650      
Principal Investigator: Saima Chohan         
University of Arizona Recruiting
Tucson, Arizona, United States, 85711
Contact    520-626-3608      
Principal Investigator: Dominick G Sudano         
United States, California
St. Joseph Heritage Medical Group Recruiting
Fullerton, California, United States, 92835
Contact    714-626-8610      
Principal Investigator: Shirley W Pang         
MD Medical Corporation Recruiting
Hemet, California, United States, 92543
Principal Investigator: Chandrakant V Mehta         
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact    310-206-3244      
Principal Investigator: Jennifer M Grossman         
ACRC Studies Recruiting
Poway, California, United States, 92064
Contact    8583121717      
Principal Investigator: Smitha Chiniga Reddy         
Medvin Clinical Research Recruiting
Whittier, California, United States, 90602
Contact    562-758-6600      
Principal Investigator: Tien-I Su         
United States, Connecticut
New England Research Associates Suspended
Bridgeport, Connecticut, United States, 06606
Yale University School of Medicine Suspended
New Haven, Connecticut, United States, 06519
United States, Florida
Lakes Research, LLC Recruiting
Miami Lakes, Florida, United States, 33014
Contact    305-362-4979      
Principal Investigator: Benidecto Fernandez         
ForCare Clinical Research Recruiting
Tampa, Florida, United States, 33613
Contact    813-264-2155      
Principal Investigator: Priya Ramani         
United States, Georgia
Piedmont Healthcare Recruiting
Atlanta, Georgia, United States, 30318
Contact    404-350-0009      
Principal Investigator: Wambui L Machua         
Atlanta Center for Clinical Research Recruiting
Atlanta, Georgia, United States, 30342
Contact    770-226-8819      
Principal Investigator: Stuart Handelsman         
United States, Idaho
St Luke's Clinic - Intermountain Orthopaedics Recruiting
Boise, Idaho, United States, 83702
Contact    208-489-4369      
Principal Investigator: Achini Dingman         
United States, Illinois
Rockford Orthopedic Associates Recruiting
Rockford, Illinois, United States, 61114
Contact    815-381-7456      
Principal Investigator: Richard Olson         
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact    319-335-9982      
Principal Investigator: Petar S Lenert         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact    617-636-5645      
Principal Investigator: Steven C Vlad         
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact    734-764-1817      
Principal Investigator: William J McCune         
Henein Arthritis Suspended
Clinton Township, Michigan, United States, 48038
Henry Ford Health System Suspended
Detroit, Michigan, United States, 48202
United States, Minnesota
St. Paul Rheumatology, PA Suspended
Eagan, Minnesota, United States, 55121
United States, Missouri
St. Louis Rheumatology Recruiting
Saint Louis, Missouri, United States, 63119
Contact    314-646-0688      
Principal Investigator: John J. Budd         
United States, Nevada
Allied Clinical Research Recruiting
Reno, Nevada, United States, 89519
Contact    775-313-9800      
Principal Investigator: Bryan J Wolf         
United States, New Mexico
Albuquerque Rehabilitation & Rheumatology, PC Recruiting
Albuquerque, New Mexico, United States, 87102
Contact    505-341-4148      
Principal Investigator: Leroy A Pacheco         
United States, New York
SUNY Health Science Center Suspended
Brooklyn, New York, United States, 11203
Northwell Health Suspended
Great Neck, New York, United States, 11021
The Feinstein Institute for Medical Research Suspended
Manhasset, New York, United States, 11030
Columbia University Medical Center Suspended
New York, New York, United States, 10032
Buffalo Rheumatology Recruiting
Orchard Park, New York, United States, 14127
Contact    7166752500      
Principal Investigator: Joseph Michael Grisanti         
United States, North Carolina
Medication Management, LLC Recruiting
Greensboro, North Carolina, United States, 27408
Contact    336-763-6968      
Principal Investigator: Tauseef G Syed         
PMG Research of Wilmington, LLC Recruiting
Wilmington, North Carolina, United States, 28401
Principal Investigator: Ronald George         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact    614-293-6869      
Principal Investigator: Alexa S Meara         
Paramount Medical Research Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact    440-891-9395      
Principal Investigator: Isam A. Diab         
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma PLLC Recruiting
Oklahoma City, Oklahoma, United States, 73102
Contact    405-606-8730      
Principal Investigator: Mohammad Khan         
United States, Pennsylvania
East Penn Rheumatology Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact    610-868-1336      
Principal Investigator: Charles L. Ludivico         
UPMC Lupus Center of Excellence Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact    412-648-9782      
Principal Investigator: Andreea Coca         
United States, Tennessee
West Tennessee Research Institute Recruiting
Jackson, Tennessee, United States, 38305
Principal Investigator: Jacob Asher Aelion         
United States, Texas
Amarillo Center for Clinical Research Recruiting
Amarillo, Texas, United States, 79124
Contact    806-352-2453      
Principal Investigator: Constantine K Saadeh         
Accurate Clinical Management LLC - BayTown Recruiting
Baytown, Texas, United States, 77521
Contact    281-851-7088      
Principal Investigator: Sabeen Najam         
Precision Comprehensive Clinical Research Solutions Not yet recruiting
Fort Worth, Texas, United States, 76107
Contact    972-342-6125      
Principal Investigator: Himabindu R Reddy         
Rheumatology Center of Houston Recruiting
Houston, Texas, United States, 77004
Contact    281-481-8557      
Principal Investigator: Jacqueline D Vo         
Southwest Rheumatology, P.A. Recruiting
Mesquite, Texas, United States, 75150
Contact    972-288-2600      
Principal Investigator: Atul K. Singhal         
Univ of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact    210-358-3555      
Principal Investigator: Agustin Escalante         
Arthritis Clinic Of Central Texas Recruiting
San Marcos, Texas, United States, 78666
Principal Investigator: Hassan M Alissa         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact    206-386-2000      
Principal Investigator: Philip J Mease         
United States, Wisconsin
Rheumatic Disease Center Recruiting
Glendale, Wisconsin, United States, 53217
Contact    414-351-4009      
Principal Investigator: Kurt Oelke         
Australia, New South Wales
Optimus Clinical Research Recruiting
Kogarah, New South Wales, Australia, 2217
Contact    61289648186      
Principal Investigator: Paul Bird         
Australia, Queensland
The Rheumatology Research Unit Sunshine Coast Recruiting
Maroochydore, Queensland, Australia, 4558
Contact    61 7 5443 1033      
Principal Investigator: Peter Nash         
Australia, Victoria
Emeritus Research Recruiting
Camberwell, Victoria, Australia, 3124
Contact    61 3 9509 6166      
Principal Investigator: Andrew Ostor         
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Contact    61395943565      
Principal Investigator: Alberta Hoi         
St Vincents Hospital Melbourne Recruiting
Fitzroy, Victoria, Australia, 3065
Contact    61394117111      
Principal Investigator: Mandana Nikpour         
Australia
Griffith University Recruiting
Southport, Australia, 4215
Contact    61755915542      
Principal Investigator: Jennifer Ng         
Austria
Ordensklinikum Linz GmbH - Elisabethinen Recruiting
Linz, Oberösterreich, Austria, 4020
Contact    43073276760      
Principal Investigator: Marija Geroldinger-Simic         
Medizinische Universität Wien Recruiting
Wien, Vienna, Austria, 1090
Contact    4314040043590      
Principal Investigator: Klaus Machold         
Medizinische Universität Graz Recruiting
Graz, Austria, 8036
Contact    433163857779      
Principal Investigator: Winfried Graninger         
KH Hietzing mit neurologischem Zentrum Rosenhügel Recruiting
Wien, Austria, 1130
Contact    431801103174      
Principal Investigator: Kurt Redlich         
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Brussel, Belgium, 1200
Contact    3227643633      
Principal Investigator: Frederic Houssiau         
UZ Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact    3216342541      
Principal Investigator: Ellen De Langhe         
CHU de Liège Recruiting
Liège, Belgium, 4000
Contact    3243668310      
Principal Investigator: Christian Von Frenckell         
Brazil
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME Suspended
Salvador, Bahia, Brazil, 40150-150
CIP-Centro Internacional de Pesquisa Suspended
Goiania, Goiás, Brazil, 74110-120
Santa Casa de Misericordia de Belo Horizonte Suspended
Belo Horizonte, MG, Brazil, 30150-221
Centro de Estudos em Terapias Inovadoras-CETI Suspended
Curitiba, Paraná, Brazil, 80030-110
EDUMED - Educação em Saúde Ltda. Recruiting
Curitiba, Paraná, Brazil, 80440-080
Contact    554130496504      
Principal Investigator: Valderilio Feijo Azevedo         
LMK Serviços Médicos S/S Suspended
Porto Alegre, Rio Grande Do Sul, Brazil, 90540-000
Hospital de Clinicas de Porto Alegre Suspended
Porto Alegre, RS, Brazil, 90035-003
Hospital de Clinicas UNICAMP Suspended
Campinas, SP, Brazil, 13083-970
Oncovida- Centro de Onco-Hematologia de Mato Grosso Suspended
Cuiaba, Brazil, 78043-142
Hospital Alemao Oswaldo Cruz Suspended
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, Hubei
Wuhan Union (Xiehe) Hospital Recruiting
Wuhan, Hubei, China, 430022
Contact    862785726136      
Principal Investigator: Anbin Huang         
China, Jiangsu
Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med Recruiting
Nanjing, Jiangsu, China, 210008
Contact    8613817544696      
Principal Investigator: Lingyun Sun         
China, Jilin
China-Japan Union Hospital of Jilin University Recruiting
Changchun Shi, Jilin, China, 100853
Contact    8603578879099      
Principal Investigator: LiQi Bi         
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact    8613701973875      
Principal Investigator: Lin Di Jiang         
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         
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 Suzhou University Recruiting
Suzhou Shi, China, 215000
Contact    86051265223637      
Principal Investigator: Jian Wu         
Tianjin Medical University General Hospital Recruiting
Tianjin, China, 300052
Contact    8613920182411      
Principal Investigator: Wei Wei         
People's Hospital of Xinjiang Uygur Autonomous Region Recruiting
Urumqi, China, 830001
Contact    8613999265917      
Principal Investigator: Li-Jun Wu         
Croatia
Klinicki Bolnicki Centar Rijeka Recruiting
Rijeka, Croatia, 51000
Contact    3855121160      
Principal Investigator: Srdjan Novak         
University Hospital Split Recruiting
Split, Croatia, 21000
Contact    38598773507      
Principal Investigator: Dijana Perkovic         
Clinical Hospital Dubrava Recruiting
Zagreb, Croatia, 10000
Contact    0038512902420      
Principal Investigator: Jadranka Morovic-Vergles         
Czechia
Revmatologie s.r.o. Recruiting
Brno, Czechia, 638 00
Contact    420 545 214 556      
Principal Investigator: Leona Prochazkova         
Fakultni Nemocnice Olomouc Recruiting
Olomouc, Czechia, 775 20
Contact    420588443373      
Principal Investigator: Pavel Horak         
Arthrohelp s.r.o Recruiting
Pardubice, Czechia, 530 02
Contact    420464007686      
Principal Investigator: Zdenek Dvorak         
Vseobecna fakultni nemocnice Recruiting
Praha 2, Czechia, 128 08
Contact    420224962605      
Principal Investigator: Vladimir Tesar         
Revmatologicky ustav Recruiting
Praha 2, Czechia, 12800
Contact    420234075338      
Principal Investigator: Dana Tegzova         
Germany
Universitätsklinikum Tübingen Recruiting
Tubingen, Baden-Wurttemberg, Germany, 72076
Contact    4970712982839      
Principal Investigator: Jörg Henes         
Universitätsklinikum Freiburg Recruiting
Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
Contact    497612707396      
Principal Investigator: Stephanie Finzel         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact    496221568604      
Principal Investigator: Norbert Blank         
Klinikum der Universität München Recruiting
München, Bayern, Germany, 80336
Contact    498970951      
Principal Investigator: Hendrik Schulze-Koops         
Universitätsklinikum Würzburg Recruiting
Würzburg, Bayern, Germany, 97080
Contact    4993120140110      
Principal Investigator: Hans-Peter Tony         
Universitätsklinikum Köln Recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Contact    492214783993      
Principal Investigator: David Kofler         
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact    496131177340      
Principal Investigator: Andreas Schwarting         
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Sachsen, Germany, 01307
Contact    49 0 3514582344      
Principal Investigator: Claudia Guenther         
Universität Leipzig - Universitätsklinikum Recruiting
Leipzig, Sachsen, Germany, 04103
Contact    493419724710      
Principal Investigator: Ulf Wagner         
Universitätsklinikum Jena Recruiting
Jena, Thüringen, Germany, 07747
Contact    '4936419324326      
Principal Investigator: Peter Oelzner         
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact    4930450513012      
Principal Investigator: Falk Hiepe         
Immanuel Krankenhaus Rheuma Klinik Berlin Buch Recruiting
Berlin, Germany, 13125
Contact    493920067319      
Principal Investigator: Andreas Krause         
Schlosspark-Klinik Recruiting
Berlin, Germany, 14059
Contact    493032641325      
Principal Investigator: Rieke Alten         
Universitätsklinikum Münster Recruiting
Munster, Germany, 48149
Contact    49 2518344994      
Principal Investigator: Heidemarie Becker         
Greece
Gen Hospital of Athens G Gennimatas Recruiting
Athens, Attiki, Greece, 11527
Contact    302107768562      
Principal Investigator: Pinelope Konstantopoulou         
University General Hospital of Heraklion Recruiting
Heraklion, Crete, Greece, 71110
Contact    302810392024      
Principal Investigator: Prodromos Sidiropoulos         
University General Hospital of Larissa Recruiting
Larissa, Greece, 41110
Contact    302413502880      
Principal Investigator: Christina Katsiari         
Euromedica Kyanous Stavros General Hospital Recruiting
Thessaloniki, Greece, 54636
Contact    302310966299      
Principal Investigator: Lucas Settas         
Ippokrateio General Hospital of Thessaloniki Recruiting
Thessaloniki, Greece, 54642
Contact    302313312000      
Principal Investigator: Alexandros Garyfallos         
Hungary
Bekes Megyei Pandy Kalman Korhaz Recruiting
Gyula, Bekes, Hungary, 5700
Contact    3666361833      
Principal Investigator: Tibor Martyin         
Budai Irgalmasrendi Korhaz Recruiting
Budapest, Hungary, 1027
Contact    3614388534      
Principal Investigator: Bernadette Rojkovich         
Qualiclinic Kft Recruiting
Budapest, Hungary, 1036
Contact    3612448249      
Principal Investigator: Istvan Szombathi         
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeze Recruiting
Budapest, Hungary, 1097
Contact    36209266272      
Principal Investigator: Janos Kadar         
Debreceni Egyetem Klinikai Kozpont Reumatologiai Tanszek Recruiting
Debrecen, Hungary, 4032
Contact    3652255218      
Principal Investigator: Tünde Tarr         
Debreceni Egyetem Klinikai Kozpont Recruiting
Debrecen, Hungary, 4032
Contact    3652411600      
Principal Investigator: Gabriella Szucs         
Pecsi Tudomanyegyetem Klinikai Kozpont Recruiting
Pecs, Hungary, 7632
Contact    3672536809      
Principal Investigator: Cecilia Varju         
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika Recruiting
Szeged, Hungary, 6725
Contact    36309081611      
Principal Investigator: Laszlo Kovacs         
Vita Verum Egeszsegugyi Szolgaltato Bt Recruiting
Székesfehérvár, Hungary, 8000
Principal Investigator: Tunde Varga         
Vital Medical Center Recruiting
Veszprem, Hungary, 8200
Contact    3688790434      
Principal Investigator: Csaba Kiss         
Israel
Carmel Medical Center Recruiting
Haifa, Israel, 3436212
Contact    97248250486      
Principal Investigator: Devy Zisman         
Hadassah Medical Center Recruiting
Jerusalem, Israel, 9112001
Contact    97226777317      
Principal Investigator: Dror Mevorach         
Meir Medical Center Recruiting
Kfar Saba, Israel, 4428164
Contact    97297472555      
Principal Investigator: Yair Levy         
Rabin Medical Center Recruiting
Petach Tikva, Israel, 4941492
Contact    97239376947      
Principal Investigator: Yair Molad         
Chaim Sheba Medical Center Recruiting
Ramat Gan, Israel, 5262100
Contact    97235302060      
Principal Investigator: Nancy Agmon-Levin         
Mexico
CIMAB S.A. de C.V. Suspended
Torreon, Coahuila, Mexico, 27000
Hospital Angeles Lindavista Suspended
Mexico city, DF, Mexico, 07760
Cliditer Sa de CV Suspended
Mexico City, Distrito Federal, Mexico, 06700
Morales Vargas Centro de Investigacion, S.C. Suspended
Leon, Guanajuato, Mexico, 37000
Centro Integral en Reumatologia SA de CV Suspended
Guadalajara, Jalisco, Mexico, 44160
Clinica en Investigación en Reumatologia y Obesidad S.C. Suspended
Guadalajara, Jalisco, Mexico, 44650
Centro de Estudios de Investigacion Metabolicos y Cardiovasc Suspended
Guadalajara, Jalisco, Mexico, 44690
Biomédica para el Desarrollo de Fármacos S.A. de C.V. Suspended
Zapopan, Jalisco, Mexico, 45030
Kohler Milstein Research, S.A. de C.V. Suspended
Merida, Yucatan, Mexico, 97070
Centro Peninsular de Investigacion S.C.P Suspended
Merida, Yucatán, Mexico, 97000
Cemdeicy S.C.P. Suspended
Merida, Yucatán, Mexico, 97130
Centro de Investigación y Tratamiento Reumatológico S.C Suspended
Ciudad De México, Mexico, 11850
Centro Medico Dalinde Suspended
Mexico City, Mexico, 06760
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C. Suspended
San Luis Potosi, Mexico, 78213
Netherlands
Zuyderland MC Recruiting
Sittard - Geleen, Limburg, Netherlands, 6162 BG
Contact    31884597983      
Principal Investigator: Cesar Magro-Checa         
Vrije Universiteit Medisch Centrum Amsterdam Recruiting
Amsterdam, Netherlands, 1081 HV
Contact    0204441084      
Principal Investigator: Irene Bultink         
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact    31503612945      
Principal Investigator: Karina de Leeuw         
Medisch Centrum Leeuwarden, locatie Leeuwarden Recruiting
Leeuwarden, Netherlands, 8934 AD
Contact    31 582866100      
Principal Investigator: R J BOS         
Russian Federation
LLC MK Med Suspended
St. Petersburg, Saint Petersburg, Russian Federation, 197372
Chelyabinsk Regional Clinical Hospital Suspended
Chelyabinsk, Russian Federation, 454076
City Hospital # 7 Suspended
Kazan, Russian Federation, 420103
Regional Clinical Hospital Suspended
Kursk, Russian Federation, 305007
Russian State Medical University Suspended
Moscow, Russian Federation, 117997
City Clinical Hospital #1 n.a. N.I.Pirogov Suspended
Moscow, Russian Federation, 119049
Moscow State University of Medicine and Dentistry n.a. Evdokimov Suspended
Moscow, Russian Federation, 123182
Rheumatology Institute RAMS Suspended
Moscow, Russian Federation
Healthy Family Suspended
Novosibirsk, Russian Federation, 630061
Reafan Suspended
Novosibirsk, Russian Federation, 630099
Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences Suspended
Novosibirsk, Russian Federation, 630117
Regional Hospital - Omsk Suspended
Omsk, Russian Federation, 644111
Orenburg State Medical Academy of Roszdrav Suspended
Orenburg, Russian Federation, 460018
Ryazan State Medical University Suspended
Ryazan, Russian Federation, 390026
Russian Medical Military Academy n.a. S.M. Kirov Suspended
Saint Petersburg, Russian Federation, 194044
Departmental Hospital at Smolensk Station "rzhd" JSC Suspended
Smolensk, Russian Federation, 214025
Kuvatov Republican Clinical Hospital Suspended
Ufa, Russian Federation, 450005
Switzerland
Universitätsspital Basel Recruiting
Basel, Basel Stadt, Switzerland, 4031
Contact    41615565017      
Principal Investigator: Bettina Bannert         
Kantonsspital St. Gallen Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Contact    41714941439      
Principal Investigator: Andrea Rubbert-Roth         
Taiwan
Chang Gung Memorial Hospital - Linkou Recruiting
Kuei Shan Hsiang, Taoyuan Hsien, Taiwan, 33305
Contact    88633281200#8812      
Principal Investigator: Yao-Fan Fang         
Buddhist Tzu-Chi General Hospital Recruiting
Dalin Township, Taiwan, 622
Contact    886526480005010      
Principal Investigator: Ning-Sheng Lai         
Chang Gung Memorial Hospital - Kaohsiung Recruiting
Kaohsiung City, Taiwan, 83301
Contact    88677317123      
Principal Investigator: Wen-Chan Chiu         
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 81346
Contact    88673468097      
Principal Investigator: Jui-Cheng Tseng         
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact    886423592525      
Principal Investigator: Joung-Liang Lan         
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 40705
Contact    8864235925253333      
Principal Investigator: Wen-Nan Huang         
Chi-Mei Medical Center Recruiting
Tainan City, Taiwan, 71004
Contact    88662812811ext57111      
Principal Investigator: Hung-An Chen         
Taipei Medical University Hospital Recruiting
Taipei City, Taiwan, 11031
Contact    886227272181      
Principal Investigator: Chi-Ching Chang         
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact    886223123456      
Principal Investigator: Cheng-Han Wu         
United Kingdom
Maidstone Hospital Suspended
Maidstone, Kent, United Kingdom, ME16 9QQ
Whipps Cross University Hospital Suspended
London, Surrey, United Kingdom, E11 1NR
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust Suspended
Doncaster, United Kingdom, DN2 5LT
Leeds Teaching Hospital Suspended
Leeds, United Kingdom, LS7 4SA
Guy's Hospital Suspended
London, United Kingdom, SE1 9RT
St. George'S Healthcare Nhs Trust Suspended
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:
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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: June 4, 2020
Last Verified: June 2020
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