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. |
| ClinicalTrials.gov Identifier: NCT03616964 |
|
Recruitment Status :
Recruiting
First Posted : August 6, 2018
Last Update Posted : June 4, 2019
|
Sponsor:
Eli Lilly and Company
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
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- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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
Genetics Home Reference related topics:
Systemic lupus erythematosus
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 :
- 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 :
- Percentage of Participants Achieving SRI-4 Response (Low Dose) [ Time Frame: Week 52 ]Percentage of participants achieving SRI-4 response (low dose).
- Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 52 ]Percentage of Participants Achieving a LLDAS.
- Time to First Severe Flare [ Time Frame: Baseline to Week 52 ]Time to first severe flare.
- Change from Baseline in Prednisone Dose [ Time Frame: Baseline, Week 52 ]Change from baseline in prednisone dose.
- Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 52 ]Change from baseline in worst pain NRS.
- 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.
- 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.
- Change from Baseline in Tender Joint Count [ Time Frame: Baseline, Week 52 ]Change from baseline in tender joint count.
- Change from Baseline in Swollen Joint Count [ Time Frame: Baseline, Week 52 ]Change from baseline in swollen joint count.
- 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).
- 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.
| 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): NCT03616964
Contacts
| 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 |
Hide Study Locations
Locations
| 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 | |
| Argentina | |
| 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 | |
| Chile | |
| 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 | |
| Colombia | |
| 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 | |
| France | |
| 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 | |
| India | |
| 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 | |
| Italy | |
| 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 | |
| Japan | |
| 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 | |
| Philippines | |
| 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 | |
| Poland | |
| 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 lek.med. 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 | |
| Romania | |
| 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 | |
| Serbia | |
| 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 | |
| Spain | |
| 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
Investigators
| 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:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov 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 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. |
| 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:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |