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

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. Identifier: NCT03616964
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : June 4, 2019
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 : April 21, 2021
Estimated Study Completion Date : May 21, 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

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 identifier (NCT number): NCT03616964

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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

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United States, Arizona
Arizona Arthritis & Rheumatology Research, PLLC Recruiting
Gilbert, Arizona, United States, 85704
Contact    480-626-6650      
Principal Investigator: Daniel E Kreutz         
Arizona Arthritis & Rheumatology Research Recruiting
Phoenix, Arizona, United States, 85302
Contact    480-626-6656      
Principal Investigator: Eric A Peters         
Arizona Arthritis & Rheumatology Research, PLLC Recruiting
Tucson, Arizona, United States, 85704
Contact    480-443-8400      
Principal Investigator: Jeffrey B Loomer         
United States, California
Wallace Rheumatic Study Center Recruiting
Beverly Hills, California, United States, 90211
Contact    13103609197      
Principal Investigator: Daniel Jeffrey Wallace         
Medvin Clinical Research Recruiting
Covina, California, United States, 91722
Contact    562-713-2596      
Principal Investigator: Samy K Metyas         
University of California - San Diego Not yet recruiting
La Jolla, California, United States, 92037
Contact    858-657-7040      
Principal Investigator: Susan Lee         
Office: Dr Robin K Dore Recruiting
Tustin, California, United States, 92780
Contact    714-505-5500      
Principal Investigator: Robin K Dore         
Inland Rheumatology Clinical Trials Recruiting
Upland, California, United States, 91786
Contact    909-296-8700      
Principal Investigator: Antony Hou         
United States, Florida
Clinical Research of West Florida Recruiting
Clearwater, Florida, United States, 33765
Contact    727-466-0078      
Principal Investigator: Robert W Levin         
Millennium Research Recruiting
Ormond Beach, Florida, United States, 32174
Contact    3866721985      
Principal Investigator: Michael David Kohen         
Integral Rheumatology & Immunology Specialists Not yet recruiting
Plantation, Florida, United States, 33324
Contact    909-580-6320      
Principal Investigator: Guillermo Valenzuela         
Clinical Research of West Florida, Inc. Recruiting
Tampa, Florida, United States, 33603
Contact    813-870-1292      
Principal Investigator: Edgard Janer         
Tampa Medical Group, P.A. Recruiting
Tampa, Florida, United States, 33614
Contact    813-840-3600      
Principal Investigator: Michael C Burnette         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-778-6638      
Principal Investigator: Arezou Khosroshahi         
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Principal Investigator: Paul Geo Sutej         
North Georgia Rheumatology, PC Recruiting
Lawrenceville, Georgia, United States, 30046
Contact    770-822-1090      
Principal Investigator: Theresa A Ford         
United States, Illinois
University of Chicago Duchosis Ctr Advanced Medicine (DCAM) Not yet recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Kimberly C Trotter         
United States, Kentucky
Arthritis Center of Lexington Recruiting
Lexington, Kentucky, United States, 40504
Contact    859-351-5175      
Principal Investigator: Alexander D Brown         
United States, Massachusetts
Brigham and Womens Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact    6177328256      
Principal Investigator: Elena Maria Massarotti         
United States, Minnesota
University of Minnesota Medical School Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact    612-626-4426      
Principal Investigator: Parastoo Fazeli         
United States, Mississippi
North MS Medical Clinics, Inc. Recruiting
Tupelo, Mississippi, United States, 38801
Contact    662-377-5131      
Principal Investigator: Charles King         
United States, Missouri
University Medical Group Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact    314-977-9600      
Principal Investigator: Reema Syed         
United States, Montana
Glacier View Research Institute Not yet recruiting
Kalispell, Montana, United States, 59901
Contact    406-755-1460      
Principal Investigator: Roger Diegel         
United States, Nevada
Innovative Health Research Recruiting
Las Vegas, Nevada, United States, 89128
Contact    7023415444      
Principal Investigator: George Timothy Kelly         
United States, New Mexico
Albuquerque Clinical Trials Recruiting
Albuquerque, New Mexico, United States, 87102
Contact    505-224-7407      
Principal Investigator: Ellen Kim         
Arthritis and Osteoporosis Associates of New Mexico Not yet recruiting
Las Cruces, New Mexico, United States, 88011
Contact    575-571-7529      
Principal Investigator: Arthur R Snyder         
United States, New York
New York University Medical Center Not yet recruiting
New York, New York, United States, 10016
Contact    212-263-6565      
Principal Investigator: David Goddard         
SUNY Upstate Medical University Not yet recruiting
Syracuse, New York, United States, 13210
Contact    315-464-4194      
Principal Investigator: Andras Perl         
United States, North Carolina
Joint and Muscle Medical Care Recruiting
Charlotte, North Carolina, United States, 28204
Contact    704-248-8577      
Principal Investigator: Alireza Nami         
Box Arthritis & Rheumatology of the Carolinas, PLLC Recruiting
Charlotte, North Carolina, United States, 28210
Contact    704-247-9179      
Principal Investigator: Emily Jane Box         
United States, Ohio
Cincinnati Rheumatic Disease Study Group @ the Deaconess Art Recruiting
Cincinnati, Ohio, United States, 45242
Contact    513-558-5538      
Principal Investigator: Michael Luggen         
United States, Oklahoma
Oklahoma Medical Research Foundation Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104-5046
Contact    405-271-7303      
Principal Investigator: Cristina Arriens         
United States, Pennsylvania
Clinical Research Center of Reading, LLC Recruiting
Wyomissing, Pennsylvania, United States, 19610
Contact    610-375-2466      
Principal Investigator: Nancy J Walker         
United States, Texas
Dr. Dhiman Basu Private Practice Not yet recruiting
Colleyville, Texas, United States, 76034
Principal Investigator: Dhiman Basu         
Metroplex Clinical Research Center Recruiting
Dallas, Texas, United States, 75231
Contact    214-879-6737      
Principal Investigator: Margarita Fallena         
Accurate Clinical Research Not yet recruiting
League City, Texas, United States, 77573
Principal Investigator: Prashanth R Sunkureddi         
Advanced Rheumatology of Houston Not yet recruiting
The Woodlands, Texas, United States, 77382
Contact    713-677-0086      
Principal Investigator: Tamar Brionez         
Clear Lake Specialties Recruiting
Webster, Texas, United States, 77598
Contact    2817241860      
Principal Investigator: Abdelnaser Naser Elkhalili         
United States, Virginia
Arthritis Clinic of Northern VA, P.C. Recruiting
Arlington, Virginia, United States, 22205
Contact    70352530698      
Principal Investigator: Philip Kempf         
Spectrum Medical Inc. Recruiting
Danville, Virginia, United States, 24541
Contact    4347934711349      
Principal Investigator: Sharukh D Shroff         
United States, Washington
Virginia Mason Medical Center Not yet recruiting
Seattle, Washington, United States, 98101
Principal Investigator: Jeffrey S Carlin         
United States, Wisconsin
Froedtert Memorial Lutheran Hospital Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: David J Gazeley         
Aprillus Asistencia e Investigacion - Servicio de neurologia Recruiting
Caba, Buenos Aires, Argentina, C1046AAQ
Contact    541149512763      
Principal Investigator: Pablo Mannucci         
Framingham Centro Medico Recruiting
La Plata, Buenos Aires, Argentina, B1902COS
Contact    542214835656      
Principal Investigator: Graciela Rodriguez         
CER Instituto Medico Not yet recruiting
Quilmes, Buenos Aires, Argentina, B1878DVC
Principal Investigator: Benito J Velasco         
Instituto de Investigaciones Clinicas Quilmes Recruiting
Quilmes, Buenos Aires, Argentina, B1878GEG
Contact    541142531337      
Principal Investigator: Jose L Velasco         
Comite de Etica en Investigacion - CEMIC Recruiting
Buenos Aires, Ciudad Autonoma De Buenos Aire, Argentina, C1431FWO
Contact    541152990247      
Principal Investigator: Cecilia Pisoni         
Sanatorio Británico Recruiting
Rosario, Santa Fe, Argentina, 2000
Contact    54114205500      
Principal Investigator: Guillermo Ariel Berbotto         
Centro Medico Privado de Reumatologia Recruiting
San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
Contact    543814200180      
Principal Investigator: Alberto Spindler         
Sanatorio Guemes Cardiocirugia Recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1181AAX
Contact    541149598200      
Principal Investigator: Adriana Hamaui         
Clinica Adventista de Belgrano Recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
Contact    541140141500      
Principal Investigator: Federico Javier Ariel         
IR Medical Center S.A. Instituto de Reumatologia Not yet recruiting
Mendoza, Argentina, M5500CPH
Principal Investigator: Alfredo Luis Borgia         
Quantum Research Santiago Not yet recruiting
Santiago, Región Metropolitana De Santia, Chile, 7500588
Principal Investigator: Carlos Roman         
Sociedad Medica Del Aparato Locomotor SA Recruiting
Santiago, Chile, 7510186
Contact    56229461298      
Principal Investigator: Marta Aliste Silva         
Prosalud y cia. Ltda. Recruiting
Santiago, Chile
Contact    56223780203      
Principal Investigator: Irmgadt Annelise Goecke Sariego         
ReumaCen Centro Reumatologico Integral Recruiting
Vina del Mar, Chile, 2570017
Contact    56994395441      
Principal Investigator: Renato Jimenez         
HPTU-El Hospital con alma Pablo Tobon Uribe Recruiting
Medellin, Antioquia, Colombia
Contact    5744459753      
Principal Investigator: Luis Pinto         
Clinica de la Costa Not yet recruiting
Barranquilla, Atlantico, Colombia
Principal Investigator: Gustavo Aroca Martinez         
Circaribe SAS Recruiting
Barranquilla, Atlántico, Colombia
Contact    5753585281      
Principal Investigator: Mauricio Abello Banfi         
Idearg S.A.S. Recruiting
Bogota, Cundinamarca, Colombia
Contact    5718059697      
Principal Investigator: Renato Guzman Moreno         
Instituto de Reumatologia Not yet recruiting
Bogota, Distrito Capital De Bogota, Colombia
Principal Investigator: Philipe Chalem         
Servimed S.A.S. Recruiting
Bucaramanga, Santander, Colombia, 12345
Contact    5776432426      
Principal Investigator: William Jose Otero Escalante         
Medicity SAS Not yet recruiting
Bucaramanga, Santander, Colombia, 681001
Contact    5776399661      
Principal Investigator: Diego Saaibi         
Centro de Medicina Interna Recruiting
Cali, Valle Del Cauca, Colombia
Contact    5725529620      
Principal Investigator: David del Castillo         
Preventive Care Ltdac Recruiting
Chia, Colombia
Contact    5718613503      
Principal Investigator: John Londono         
CHRU Brest - Hopital Cavale Blanche Not yet recruiting
Brest Cedex, Finistère, France, 29609
Principal Investigator: Sandrine Jousse-Joulin         
Centre hospitalier universitaire de Haut Leveque Recruiting
Pessac, Gironde, France, 33604
Contact    33557656483      
Principal Investigator: Jean-François Viallard         
CHU Lille - Hôpital Claude Huriez Not yet recruiting
Lille cedex, Nord, France, 59037
Contact    33320444714      
Principal Investigator: Eric Hachulla         
Centre hospitalier universitaire Pellegrin Recruiting
Bordeaux, France, 33076
Contact    33556795545      
Principal Investigator: Christophe RICHEZ         
Hopital Européen Recruiting
Marseille, France, 13003
Contact    33616834430      
Principal Investigator: Laurent Chiche         
Centre hospitalier universitaire Lapeyronie Not yet recruiting
Montpellier Cedex 5, France, 34295
Contact    33467336135      
Principal Investigator: Jacques Morel         
Krishna Institute of Medical Sciences Ltd. Not yet recruiting
Hyderabad, Andhra Pradesh, India, 500003
Contact    914044885151      
Principal Investigator: Sarath Chandra Mouli Veeravalli         
Panchshil Hospital Recruiting
Ahmedabad, Gujarat, India, 380005
Contact    918244273761      
Principal Investigator: Vishnu Sharma         
CIMS Hospital Private Limited Recruiting
Ahmedabad, Gujarat, India, 380060
Contact    919664078699      
Principal Investigator: Reena Sharma         
NHL Municipal Medical College & VS General Hospital Recruiting
Ahmedabad, Gujarat, India, 38006
Contact    919879144653      
Principal Investigator: Sapan Pandya         
Sterling Hospital Recruiting
Vadodara, Gujarat, India, 390007
Contact    919824094749      
Principal Investigator: Ripal Shah         
St. John Medical College & Hospital Not yet recruiting
Bangalore, Karnataka, India, 560034
Contact    918025503697      
Principal Investigator: Vineeta Shobha         
Chanre Rheumatology & Immunology Center & Research Not yet recruiting
Bangalore, Karnataka, India, 560079
Contact    918023235599      
Principal Investigator: Srikantiah Chandrashekara         
Sushruta Multispecialty Hospital & Research Center Pvt Ltd Recruiting
Hubli, Karnataka, India, 580021
Contact    919343649883      
Principal Investigator: Vikram Haridas         
Kasturba Medical College Hospital, Mangalore Recruiting
Mangalore, Karna, India, 575001
Contact    918023235599      
Principal Investigator: Mukhyaprana Prabhu         
Jasleen Hospital Recruiting
Nagpur, Maharashtra, India, 44012
Contact    919823514680      
Principal Investigator: Smruti Ramteke         
Fortis Escorts Hospital Not yet recruiting
Jaipur, Rajasthan, India, 302017
Contact    919824094749      
Principal Investigator: Amit Sharma         
Post Graduate Institute of Medical Education & Research Not yet recruiting
Chandigarh, India, 160012
Contact    917087183518      
Principal Investigator: Aman Sharma         
Azienda Ospedaliera Universitaria Not yet recruiting
Modena, MO, Italy, 41124
Principal Investigator: CARLO SALVARANI         
Azienda Ospedaliera - Universitaria Pisana Not yet recruiting
Pisa, Toscana, Italy, 56100
Contact    39050558603      
Principal Investigator: Marta Mosca         
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova Recruiting
Genova, Italy, 16132
Contact    390103537994      
Principal Investigator: Maurizio Cutolo         
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico Recruiting
Milano, Italy, 20122
Contact    390255035272      
Principal Investigator: Lorenzo Beretta         
Azienda Policlinico Umberto I Recruiting
Roma, Italy, 00161
Contact    390649974661      
Principal Investigator: Fabrizio Conti         
Azienda Ospedaliera Santa Maria Della Misericordia Not yet recruiting
Udine, Italy, 33100
Contact    390432559800      
Principal Investigator: Salvatore De Vita         
University of Occupational and Enviromental Health Recruiting
Kitakyushu, Fukuoka, Japan, 807-8556
Contact    81120360605      
Principal Investigator: Kazuhisa Nakano         
Hiroshima University Hospital Recruiting
Hiroshima-shi, Hiroshima-ken, Japan, 734-8551
Contact    81120360605      
Principal Investigator: Eiji Sugiyama         
National Hospital Organization Asahikawa Medical Center Recruiting
Asahikawa, Hokkaido, Japan, 070-8644
Contact    81120360605      
Principal Investigator: Fuminori Hirano         
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact    81120360605      
Principal Investigator: Tatsuya Atsumi         
Kobe University Hospital Recruiting
Kobe, Hyogo, Japan, 650-0017
Contact    81120360605      
Principal Investigator: Akio Morinobu         
Kagawa University Hospital Recruiting
Kita-gun, Kagawa, Japan, 761-0793
Contact    81120360605      
Principal Investigator: Hiroaki Dobashi         
Tohoku University Hospital Recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Contact    81120360605      
Principal Investigator: Tomonori Ishii         
Tomishiro Central Hospital Recruiting
Tomigusuku, Okinawa, Japan, 901-0243
Contact    81120360605      
Principal Investigator: Eishi Uechi         
Seirei Hamamatsu General Hospital Recruiting
Hamamatsu, Shizuoka, Japan, 430-8558
Contact    81120360605      
Principal Investigator: Toshiaki Miyamoto         
Nippon Medical School Hospital Recruiting
Bunkyo-Ku, Tokyo, Japan, 113 8603
Contact    81120360605      
Principal Investigator: Seiji Kobayashi         
Juntendo University Hospital Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Contact    81120360605      
Principal Investigator: Naoto Tamura         
St. Lukes International Hospital Recruiting
Chuo-Ku, Tokyo, Japan, 104 8560
Contact    81120360605      
Principal Investigator: Hiromichi Tamaki         
Toho University Ohashi Medical Center Recruiting
Meguro-ku, Tokyo, Japan, 153-8515
Contact    81120360605      
Principal Investigator: Hideto Kameda         
Keio University Hospital Recruiting
Shinjuku-Ku, Tokyo, Japan, 160-8582
Contact    81120360605      
Principal Investigator: Hironari Hanaoka         
National Hospital Organization Kyushu Medical Center Recruiting
Fukuoka, Japan, 810 8563
Contact    81120360605      
Principal Investigator: Tomoya Miyamura         
Hamanomachi Hospital Recruiting
Fukuoka, Japan, 810-8539
Contact    81120360605      
Principal Investigator: Seiji Yoshizawa         
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact    82317878211      
Principal Investigator: Yun Jong Lee         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Korea, Republic of, 21565
Contact    82324608426      
Principal Investigator: Han Joo Baek         
Hanyang University Medical Center Recruiting
Seoul, Korea, Korea, Republic of, 04763
Contact    82222909205      
Principal Investigator: Sang-Cheol Bae         
The Catholic University of Korea-Seoul St. Mary's Hospital Not yet recruiting
Seocho-Gu, Seoul, Korea, Republic of, 06591
Principal Investigator: Sunghwan Park         
Kyung Pook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
Contact    82534205495      
Principal Investigator: Young Mo Kang         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 35015
Contact    82422808712      
Principal Investigator: Seung Cheol Shim         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact    82230103280      
Principal Investigator: Chang Keun Lee         
Mary Mediatrix Medical Center Not yet recruiting
Lipa, Batangas, Philippines, 4217
Contact    634377368001202      
Principal Investigator: Allan Lanzon         
Cebu Doctors Hospital Not yet recruiting
Cebu City, Cebu, Philippines, 6000
Contact    639189308441      
Principal Investigator: Merle Barba         
Southern Philippines Medical Center Not yet recruiting
Davao, Davao Del Norte, Philippines, 8000
Contact    63822271496      
Principal Investigator: Edgar Ramiterre         
Angeles University Foundation and Medical Center Not yet recruiting
Angeles City, Pampanga, Philippines, 2009
Contact    63456246115      
Principal Investigator: Harold Michael Gomez         
Chong Hua Medical Arts Center Not yet recruiting
Cebu City, Philippines, 6000
Contact    639327066765      
Principal Investigator: James Bermas         
Makati Medical Center Recruiting
Makati City, Philippines, 1229
Contact    63288889997179      
Principal Investigator: Andrei Rhoneil Rodriguez         
St. Luke's Medical Center Not yet recruiting
Quenzon City, Philippines, 1102
Principal Investigator: Sandra Navarra         
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o. Recruiting
Wroclaw, Dolnoslaskie, Poland, 53224
Contact    48717343300      
Principal Investigator: Piotr Wiland         
Medycyna Kliniczna Recruiting
Warszawa, Mazowieckie, Poland, 00874
Contact    48228444241      
Principal Investigator: Katarzyna Romanowska-Prochnicka         
Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk Recruiting
Bialystok, Podlaskie, Poland, 15099
Contact    48604442168      
Principal Investigator: Piotr Klimiuk         
Zespol Poradni Specjalistycznych REUMED Not yet recruiting
Lublin, Polska, Poland, 20582
Principal Investigator: Mariusz Piotrowski         
Szpital Uniwersytecki nr 2 im. dr J. Biziela Recruiting
Bydgoszcz, Poland, 85-168
Contact    48523655731      
Principal Investigator: Rafal Wojciechowski         
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Barbara Bazela Recruiting
Elblag, Poland, 82-300
Contact    48784681482      
Principal Investigator: Barbara Bazela         
Centrum Medyczne Pratia Katowice Recruiting
Katowice, Poland, 40-081
Contact    48511926507      
Principal Investigator: Tomasz Dziewit         
Centrum Medyczne Plejady Recruiting
Krakow, Poland, 30383
Contact    48502662186      
Principal Investigator: Magdalena Celinska-Lowenhoff         
Lecznica MAK-MED, NZOZ Recruiting
Nadarzyn, Poland, 05-830
Contact    48468552011      
Principal Investigator: Marek Krogulec         
SP Szpital Kliniczny Nr 1 im. prof. Tadeusza Sokolowskiego Not yet recruiting
Szczecin, Poland, 71-252
Principal Investigator: Marek Brzosko         
Reumatika Centrum Reumatologii Recruiting
Warszawa, Poland, 02-691
Contact    48224895428      
Principal Investigator: Anna Zubrzycka-Sienkiewicz         
Centrum Medyczne AMED Not yet recruiting
Warszawa, Poland, 03-291
Contact    48224004041      
Principal Investigator: Anna Dudek         
Napoca Emergency Clinical County Hospital Recruiting
Napoca, Cluj, Romania, 40006
Contact    40264591942      
Principal Investigator: Simona Rednic         
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL Recruiting
Brasov, Romania, 500283
Contact    40723237553      
Principal Investigator: Anca Ioana Purcaru         
SANA Medical Center Recruiting
Bucharest, Romania, 11025
Contact    40723698925      
Principal Investigator: Cristina Pop         
St. Maria Clinical Hospital Not yet recruiting
Bucharest, Romania, 11172
Principal Investigator: Florian Berghea         
Euroclinic Hospital Recruiting
Bucharest, Romania, 14461
Contact    40726767514      
Principal Investigator: Horia Chicos         
Spitalul Clinic Sf Maria Bucuresti Recruiting
Bucuresti, Romania, 011172
Contact    40212224064      
Principal Investigator: Violeta Bojinca         
Spitalul Clinic "Dr. Ioan Cantacuzino" Recruiting
Bucuresti, Romania, 020475
Contact    40212107100      
Principal Investigator: Mihai Bojinca         
Clinical Center of Serbia Recruiting
Belgrade, Serbia, 11000
Contact    381113663222      
Principal Investigator: Aleksandra Peric-Popadic         
Clinical Center of Serbia Not yet recruiting
Belgrade, Serbia, 11000
Contact    381113615552      
Principal Investigator: Dusan Skiljevic         
Institute of Rheumatology Recruiting
Belgrade, Serbia, 11000
Contact    381648833030      
Principal Investigator: Mirjana Sefik-Bukilica         
Institute of Rheumatology Recruiting
Belgrade, Serbia, 11000
Contact    381113600802      
Principal Investigator: Nemanja Damjanov         
Institute of Rheumatology Recruiting
Belgrade, Serbia, 11000
Contact    381648833001      
Principal Investigator: Goran Radunovic         
Military Medical Academy Recruiting
Belgrade, Serbia, 11000
Contact    381641772580      
Principal Investigator: Milan Petronijevic         
Institute for Treatment and Rehabilitation Niska Banja Recruiting
Niska Banja, Serbia, 18205
Contact    381643002526      
Principal Investigator: Nedovic Jovan         
Clinical Center of Vojvodina Recruiting
Novi Sad, Serbia, 21000
Contact    381214843484      
Principal Investigator: Tatjana Ilic         
South Africa
Charlotte Maxeke Johannesburg Academic Hospital Recruiting
Parktown, Guateng, South Africa, 2000
Contact    27114883215      
Principal Investigator: Ahmed Solomon         
NetCare Umhlanga Medical Centre Not yet recruiting
Umhlanga, Kwa-Zulu Natal, South Africa, 4321
Contact    27315666939      
Principal Investigator: Asokan Naidoo         
Vincent Palloti Hospital-Dick Williamson Med Center Not yet recruiting
Cape Town, Western Cape, South Africa, 7405
Contact    27215310090      
Principal Investigator: Rehana Bhorat         
Panorama Medical Centre Not yet recruiting
Cape Town, Western Cape, South Africa, 7506
Contact    27219307602      
Principal Investigator: Ingrid Louw         
Winelands Medical Research Centre Not yet recruiting
Stellenbosch, Western Cape, South Africa, 7600
Contact    27218828252      
Principal Investigator: Gareth Tarr         
Suite 209A Jakaranda Hospital Not yet recruiting
Pretoria, South Africa, 0002
Contact    27123430428      
Principal Investigator: Elsa Van Duuren         
University Of Pretoria Not yet recruiting
Pretoria, South Africa, 0002
Contact    27123201580      
Principal Investigator: Mahmoud Ally         
Hospital Marina Baixa Recruiting
La Vila Joiosa, Alicante, Spain, 03570
Contact    34965125120      
Principal Investigator: Jose Rosas Gomez De Salazar         
Hospital De Fuenlabrada Recruiting
Fuenlabrada, Madrid, Spain, 28944
Contact    34916006206      
Principal Investigator: Raul Veiga Cabello         
Hospital Meixoeiro Recruiting
Vigo, Pontevedra, Spain, 36200
Contact    34986811111      
Principal Investigator: Jose María Pego Reigosa         
Corporació Sanitaria Parc Tauli Recruiting
Sabadell, Sapin, Spain, 08208
Contact    3493723101024065      
Principal Investigator: Joan Calvet Fontova         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact    934893000      
Principal Investigator: Josefina Cortes-Hernandez         
Corporació Sanitària Clínic Recruiting
Barcelona, Spain, 8036
Contact    34932275774      
Principal Investigator: Gerard Espinosa         
Hospital Infanta Luisa Recruiting
Sevilla, Spain, 41010
Contact    34954330856      
Principal Investigator: Juan Miguel Sanchez Burson         
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
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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 Identifier: NCT03616964     History of Changes
Other Study ID Numbers: 16677
I4V-MC-JAIA ( Other Identifier: Eli Lilly and Company )
2017-005027-25 ( EudraCT Number )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
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 This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through 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:

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases