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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. Identifier: NCT03616912
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : November 5, 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 : May 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): NCT03616912

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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, 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 Not yet 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 Not yet 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 Recruiting
Bridgeport, Connecticut, United States, 06606
Contact    203-325-8529      
Principal Investigator: Geoffrey S Gladstein         
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact    203-785-2454      
Principal Investigator: Fotios Koumpouras         
United States, Florida
Lakes Research, LLC Recruiting
Miami Lakes, Florida, United States, 33014
Contact    305-362-4979      
Principal Investigator: Benidecto Fernandez         
Omega Research Metro West, LLC Not yet recruiting
Orlando, Florida, United States, 32835
Principal Investigator: Kwabena Ayesu         
ForCare Clinical Research Not yet 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 Not yet 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 Not yet recruiting
Clinton Township, Michigan, United States, 48038
Principal Investigator: Violette F Henein         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact    412-648-4701      
Principal Investigator: Kathleen M Maksimowicz-McKinnon         
United States, Minnesota
St. Paul Rheumatology, PA Recruiting
Eagan, Minnesota, United States, 55121
Contact    651-644-4277      
Principal Investigator: Elvia G Moreta         
United States, Missouri
Clayton Medical Research Recruiting
Saint Louis, Missouri, United States, 63117
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 Recruiting
Brooklyn, New York, United States, 11203
Contact    718-270-1662      
Principal Investigator: Ellen M Ginzler         
Northwell Health Recruiting
Great Neck, New York, United States, 11021
Contact    5164706901      
Principal Investigator: Richard Alan Furie         
The Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Contact    5165623838      
Principal Investigator: Meggan Claire Mackay         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact    212-305-0856      
Principal Investigator: Anca Askanase         
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 Not yet 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: Ghaith Noaiseh         
United States, Tennessee
West Tennessee Research Institute Not yet 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         
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 Not yet 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
Aurora Rheumatology Not yet recruiting
Franklin, Wisconsin, United States, 53132
Contact    4144350025      
Principal Investigator: Alvin Francis Wells         
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         
Griffith University Not yet recruiting
Southport, Australia, 4215
Contact    61755915542      
Principal Investigator: Jenny Ng         
Ordensklinikum Linz GmbH - Elisabethinen Recruiting
Linz, Oberösterreich, Austria, 4020
Contact    43073276760      
Principal Investigator: Norbert Thomas Sepp         
Medizinische Universität Wien - Kinder und Jugendheilkunde 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         
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact    3227643633      
Principal Investigator: Frederic Houssiau         
UZ Leuven Recruiting
Leuven, Belgium, 3000
Principal Investigator: Ellen De Langhe         
CHU de Liège Recruiting
Liège, Belgium, 4000
Contact    3243668310      
Principal Investigator: Christian Von Frenckell         
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME Recruiting
Salvador, Bahia, Brazil, 40150-150
Contact    557130229886      
Principal Investigator: Santiago Mittermayer Barreto         
CIP-Centro Internacional de Pesquisa Recruiting
Goiania, Goiás, Brazil, 74110-120
Contact    556232293280      
Principal Investigator: Antonio Carlos Ximenes         
Santa Casa de Misericordia de Belo Horizonte Recruiting
Belo Horizonte, MG, Brazil, 30150-221
Contact    5531323140179      
Principal Investigator: Claudia Lopes Santoro Neiva         
Centro de Estudos em Terapias Inovadoras-CETI Recruiting
Curitiba, Paraná, Brazil, 80030-110
Contact    554130223482      
Principal Investigator: Sebastiao C. Radominski         
EDUMED - Educação em Saúde Ltda. Recruiting
Curitiba, Paraná, Brazil, 80440-080
Contact    554130496504      
Principal Investigator: Valderilio Feijo Azevedo         
LMK Serviços Médicos S/S Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90540-000
Contact    555133205057      
Principal Investigator: Mauro Waldemar Keiserman         
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact    55513168117      
Principal Investigator: Joao C. Brenol         
Hospital de Clinicas UNICAMP Recruiting
Campinas, SP, Brazil, 13083-970
Contact    55197887342      
Principal Investigator: Simone Appenzeller         
Oncovida- Centro de Onco-Hematologia de Mato Grosso Recruiting
Cuiaba, Brazil, 78043-142
Contact    5565999824011      
Principal Investigator: Luis-Sergio Guedes-Barbosa         
Hospital Alemao Oswaldo Cruz Not yet recruiting
Sao Paulo, Brazil, 01323-903
Contact    551135490391      
Principal Investigator: Jussara A L Kochen         
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 Not yet 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 Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact    8613701973875      
Principal Investigator: Lin Di Jiang         
China, Zhejiang
Second Affiliate Hospital of Zhejiang Medical University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact    05717783858      
Principal Investigator: Hua-Xiang Wu         
Ningbo First Hospital Not yet recruiting
Ningbo, Zhejiang, China, 315010
Contact    86138 5782 6442      
Principal Investigator: Xiudi Wu         
Peking University First Hospital Not yet 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         
Klinicki Bolnicki Centar Rijeka Not yet recruiting
Rijeka, Croatia, 51000
Contact    38551658187      
Principal Investigator: Srdjan Novak         
University Hospital Split Not yet recruiting
Split, Croatia, 21000
Contact    38598773507      
Principal Investigator: Dijana Perkovic         
Clinical Hospital Dubrava Not yet recruiting
Zagreb, Croatia, 10000
Contact    0038512902420      
Principal Investigator: Jadranka Morovic-Vergles         
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, 128 50
Contact    420234075338      
Principal Investigator: Dana Tegzova         
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         
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 Not yet recruiting
Munster, Germany, 48149
Principal Investigator: Heidemarie Becker         
Gen Hospital of Athens G Gennimatas Recruiting
Athens, Attiki, Greece, 11527
Contact    302107768562      
Principal Investigator: Pinelope Konstantopoulou         
University General Hospital of Heraklion Not yet recruiting
Heraklion, Crete, Greece, 71110
Contact    302810392024      
Principal Investigator: Prodromos Sidiropoulos         
Regional General University Hospital of Larissa Not yet recruiting
Larissa, Greece, 41 221
Contact    302413502880      
Principal Investigator: Dimitrios Bogdanos         
Euromedica Kyanous Stavros General Hospital Recruiting
Thessaloniki, Greece, 54636
Contact    302310966299      
Principal Investigator: Lucas Settas         
Ippokrateio General Hospital of Thessaloniki Not yet recruiting
Thessaloniki, Greece, 54642
Contact    302313312000      
Principal Investigator: Alexandros Garyfallos         
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         
Mentaház Magánorvosi Központ Kft. Recruiting
Székesfehérvár, Hungary, 8000
Contact    36204396636      
Principal Investigator: Tunde Varga         
Vital Medical Center Recruiting
Veszprem, Hungary, 8200
Contact    3688790434      
Principal Investigator: Csaba Kiss         
Carmel Medical Center Recruiting
Haifa, Israel, 3436212
Contact    97248250486      
Principal Investigator: Devy Zisman         
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel, 9112001
Contact    97226777317      
Principal Investigator: Dror Mevorach         
Meir Medical Center Ethics Committee 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         
CIMAB S.A. de C.V. Recruiting
Torreon, Coahuila, Mexico, 27000
Contact    528717130315      
Principal Investigator: Sandra Araceli Sicsik Ayala         
Hospital Angeles Lindavista Recruiting
Mexico city, DF, Mexico, 07760
Principal Investigator: Sandra Miriam Carrillo Vazquez         
Cliditer Sa de CV Recruiting
Mexico City, Distrito Federal, Mexico, 06700
Contact    5215552079761      
Principal Investigator: Gabriel Medrano         
Morales Vargas Centro de Investigacion, S.C. Not yet recruiting
Leon, Guanajuato, Mexico, 37000
Contact    524777145559      
Principal Investigator: Jorge Morales-Torres         
Centro Integral en Reumatologia SA de CV Recruiting
Guadalajara, Jalisco, Mexico, 44160
Contact    526646340662      
Principal Investigator: Hilario Avila-Armengol         
Clinica en Investigación en Reumatologia y Obesidad S.C. Recruiting
Guadalajara, Jalisco, Mexico, 44650
Contact    523331200700      
Principal Investigator: Sergio Duran Barragan         
Centro de Estudios de Investigacion Metabolicos y Cardiovasc Recruiting
Guadalajara, Jalisco, Mexico, 44690
Contact    523336300946      
Principal Investigator: Ignacio Garcia de la Torre         
Biomédica para el Desarrollo de Fármacos S.A. de C.V. Recruiting
Zapopan, Jalisco, Mexico, 45030
Contact    52 3315220008      
Principal Investigator: Adriana Sanchez Ortiz         
Consultorio Jose Luis Garcia Figueroa Not yet recruiting
Villahermosa, Tabasco, Mexico, 89190
Principal Investigator: Jose Luis Garcia Figueroa         
Kohler Milstein Research, S.A. de C.V. Recruiting
Merida, Yucatan, Mexico, 97070
Contact    529999204040558      
Principal Investigator: Jesus Abraham Simon Campos         
Centro Peninsular de Investigacion S.C.P Recruiting
Merida, Yucatán, Mexico, 97000
Contact    529999277003      
Principal Investigator: Jose A. Covarrubias         
Cemdeicy S.C.P. Recruiting
Merida, Yucatán, Mexico, 97130
Contact    529999202402      
Principal Investigator: Efren Alberto Canul Novelo         
Centro de Investigación y Tratamiento Reumatológico S.C Recruiting
Ciudad De México, Mexico, 11850
Contact    11525552003516      
Principal Investigator: Fedra Irazoque-Palazuelos         
Centro Medico Dalinde Not yet recruiting
Mexico City, Mexico, 06760
Principal Investigator: Maria Araujo Arias         
Oaxaca Site Management Organization SC Not yet recruiting
Oaxaca, Mexico, 68000
Contact    529515147056      
Principal Investigator: Sergio García Méndez         
Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C. Recruiting
San Luis Potosi, Mexico, 78213
Contact    524448340562      
Principal Investigator: Juan Cruz Cruz Rizo Rodriguez         
Zuyderland MC Not yet recruiting
Sittard - Geleen, Limburg, Netherlands, 6162 BG
Contact    31884597983      
Principal Investigator: Cesar Magro-Checa         
Vrije Universiteit Medisch Centrum Amsterdam Not yet recruiting
Amsterdam, Netherlands, 1081 HV
Contact    0204441084      
Principal Investigator: Irene Bultink         
Universitair Medisch Centrum Groningen Not yet recruiting
Groningen, Netherlands, 9713 GZ
Contact    31503612945      
Principal Investigator: Karina de Leeuw         
Medisch Centrum Leeuwarden, locatie Leeuwarden Not yet recruiting
Leeuwarden, Netherlands, 8934 AD
Contact    31 582866100      
Principal Investigator: R J BOS         
Russian Federation
LLC MK Med Recruiting
St. Petersburg, Saint Petersburg, Russian Federation, 197372
Principal Investigator: Alexandra Smakotina         
Chelyabinsk Regional Clinical Hospital Recruiting
Chelyabinsk, Russian Federation, 454076
Contact    73512472457      
Principal Investigator: Olga Nesmeyanova         
City Hospital # 7 Recruiting
Kazan, Russian Federation, 420103
Contact    79178617875      
Principal Investigator: Artem Vasilyev         
Regional Clinical Hospital Recruiting
Kursk, Russian Federation, 305007
Contact    78471222001      
Principal Investigator: Larisa Knyazeva         
Russian State Medical University Recruiting
Moscow, Russian Federation, 117997
Contact    79265345912      
Principal Investigator: Ivan Gordeev         
City Clinical Hospital #1 n.a. N.I.Pirogov Recruiting
Moscow, Russian Federation, 119049
Contact    7495536 92 33      
Principal Investigator: Evgeniya Shmidt         
City Clinical Hospital # 52 Recruiting
Moscow, Russian Federation, 123182
Contact    7 910 445 11 75      
Principal Investigator: Alena Zagrebneva         
Rheumatology Institute RAMS Recruiting
Moscow, Russian Federation
Contact    74996144459      
Principal Investigator: Tatyana Reshetnyak         
Healthy Family Recruiting
Novosibirsk, Russian Federation, 630061
Contact    73833322959      
Principal Investigator: Elena Zonova         
Reafan Recruiting
Novosibirsk, Russian Federation, 630099
Contact    0073832226065      
Principal Investigator: Alexei Sizikov         
Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences Recruiting
Novosibirsk, Russian Federation, 630117
Contact    79137425577      
Principal Investigator: Maksim Korolev         
Regional Hospital - Omsk Recruiting
Omsk, Russian Federation, 644111
Contact    73812241057      
Principal Investigator: Tatiana Kropotina         
Orenburg State Medical Academy of Roszdrav Recruiting
Orenburg, Russian Federation, 460018
Contact    79068312567      
Principal Investigator: Olga Bugrova         
Ryazan State Medical University Recruiting
Ryazan, Russian Federation, 390026
Contact    74912768406      
Principal Investigator: Sergey Yakushin         
Russian Medical Military Academy n.a. S.M. Kirov Recruiting
Saint Petersburg, Russian Federation, 194044
Contact    78122718780      
Principal Investigator: Alexander Gordienko         
Departmental Hospital at Smolensk Station "rzhd" JSC Recruiting
Smolensk, Russian Federation, 214025
Contact    74812606462      
Principal Investigator: Diana Krechikova         
Kuvatov Republican Clinical Hospital Recruiting
Ufa, Russian Federation, 450005
Contact    73472289579      
Principal Investigator: Rimma Kamalova         
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         
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 Not yet 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 Recruiting
Maidstone, Kent, United Kingdom, ME16 9QQ
Contact    441622225033      
Principal Investigator: Michael Batley         
Whipps Cross University Hospital Recruiting
London, Surrey, United Kingdom, E11 1NR
Contact    442085395522      
Principal Investigator: Angela Pakozdi         
Guy's Hospital Recruiting
London, Surrey, United Kingdom, SE1 9RT
Contact    442071885040      
Principal Investigator: David D'Cruz         
Doncaster Royal Infirmary Recruiting
Doncaster, United Kingdom, DN2 5LH
Contact    447753514929      
Principal Investigator: Chee-Seng Yee         
Leeds Teaching Hospital Recruiting
Leeds, United Kingdom, LS7 4SA
Contact    4401132068801      
Principal Investigator: Edward Vital         
St. George'S Healthcare Nhs Trust Recruiting
London, United Kingdom, SW17 0QT
Contact    44 20 8725 3596      
Principal Investigator: Arvind Kaul         
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: NCT03616912     History of Changes
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: November 5, 2019
Last Verified: November 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