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 : August 5, 2020
|
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 : | October 15, 2021 |
| Estimated Study Completion Date : | November 15, 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 |
Locations
Hide 177 study locations
| United States, Arizona | |
| University of Arizona Arthritis Center | Recruiting |
| Gilbert, Arizona, United States, 85297 | |
| 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 | 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, Colorado | |
| Denver Arthritis Center | Recruiting |
| Denver, Colorado, United States, 80230 | |
| Contact 303-394-2828 | |
| Principal Investigator: Christopher R Antolini | |
| 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 | 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 | |
| Contact 4042555956 | |
| 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 | |
| Contact 773-702-2294 | |
| 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, Maryland | |
| Johns Hopkins University School of Medicine | Not yet recruiting |
| Baltimore, Maryland, United States, 21224-6801 | |
| Contact 410-550-8790 | |
| Principal Investigator: Homa Timlin | |
| United States, Michigan | |
| Advanced Rheumatology | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact 517-908-3600 | |
| Principal Investigator: Monika Mohan | |
| 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 | 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 | Recruiting |
| Las Cruces, New Mexico, United States, 88011 | |
| Contact 575-571-7529 | |
| Principal Investigator: Arthur R Snyder | |
| United States, New York | |
| St. Lawrence Health System | Recruiting |
| Canton, New York, United States, 13617 | |
| Contact 315-261-6312 | |
| Principal Investigator: Eyal Kedar | |
| New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact 212-263-6565 | |
| Principal Investigator: David Goddard | |
| SUNY Upstate Medical University | 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 | 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, South Carolina | |
| Articularis Healthcare d/b/a/ Low Country Rheumatology, PA | Recruiting |
| North Charleston, South Carolina, United States, 29406 | |
| Contact 843-572-1818 | |
| Principal Investigator: Nicholas Holdgate | |
| United States, Tennessee | |
| Eagle Medical | Recruiting |
| Crossville, Tennessee, United States, 38555 | |
| Contact 931-456-6057 | |
| Principal Investigator: Pierre Berry | |
| United States, Texas | |
| Dr. Dhiman Basu Private Practice | Recruiting |
| Colleyville, Texas, United States, 76034 | |
| Contact 972-342-6125 | |
| Principal Investigator: Dhiman Basu | |
| Metroplex Clinical Research Center | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact 214-879-6737 | |
| Principal Investigator: Margarita Fallena | |
| Advanced Rheumatology of Houston | 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 | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact 206-287-1026 | |
| Principal Investigator: Jeffrey S Carlin | |
| United States, Wisconsin | |
| Froedtert Memorial Lutheran Hospital | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact 141-805-7390 | |
| 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 | |
| DOM Centro de Reumatologia | Recruiting |
| Ciudad de Buenos Aires, Buenos Aires, Argentina, C1111AAH | |
| Contact 541148277000 | |
| Principal Investigator: Cecilia Asnal | |
| Framingham Centro Medico | Recruiting |
| La Plata, Buenos Aires, Argentina, B1902COS | |
| Contact 542214835656 | |
| Principal Investigator: Graciela Rodriguez | |
| CER Instituto Medico | Recruiting |
| Quilmes, Buenos Aires, Argentina, B1878DVC | |
| Contact 541143509608 | |
| 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 | |
| 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 | Recruiting |
| Mendoza, Argentina, M5500CPH | |
| Contact 542614257028 | |
| Principal Investigator: Alfredo Luis Borgia | |
| Centro Medico Privado de Reumatologia | Recruiting |
| Tucuman, Argentina, T4000AXL | |
| Contact 543814200180 | |
| Principal Investigator: Alberto Spindler | |
| Chile | |
| Clinical Research Chile SpA | Suspended |
| Valdivia, Los Ríos, Chile, 5110683 | |
| Quantum Research Santiago | Suspended |
| Santiago, Región Metropolitana, Chile, 7500588 | |
| Clinica Alemana de Osorno | Suspended |
| Osorno, Chile, 5290000 | |
| Sociedad Medica Del Aparato Locomotor SA | Suspended |
| Santiago, Chile, 7510186 | |
| Prosalud y cia. Ltda. | Suspended |
| Santiago, Chile | |
| ReumaCen Centro Reumatologico Integral | Suspended |
| Vina del Mar, Chile, 2570017 | |
| Colombia | |
| HPTU-El Hospital con alma Pablo Tobon Uribe | Suspended |
| Medellin, Antioquia, Colombia | |
| Clinica de la Costa | Suspended |
| Barranquilla, Atlantico, Colombia | |
| Circaribe SAS | Suspended |
| Barranquilla, Atlántico, Colombia | |
| Idearg S.A.S. | Suspended |
| Bogota, Cundinamarca, Colombia | |
| Centro Integral de Reumatologia e Inmunologia | Suspended |
| Bogotá, Cundinamarca, Colombia | |
| Instituto de Reumatologia | Suspended |
| Bogota, Distrito Capital De Bogota, Colombia | |
| Servimed S.A.S. | Suspended |
| Bucaramanga, Santander, Colombia, 12345 | |
| Medicity SAS | Suspended |
| Bucaramanga, Santander, Colombia, 681001 | |
| Centro de Medicina Interna | Suspended |
| Cali, Valle Del Cauca, Colombia | |
| Preventive Care Ltdac | Suspended |
| Chia, Colombia | |
| France | |
| APHM Hôpital de la Timone | Recruiting |
| Marseille, Bouches-du-Rhône, France, 13385 | |
| Contact 33491388978 | |
| Principal Investigator: Nicolas Schleinitz | |
| CHRU Brest - Hopital Cavale Blanche | Recruiting |
| Brest Cedex, Finistère, France, 29609 | |
| Contact 33298347267 | |
| Principal Investigator: Sandrine Jousse-Joulin | |
| Centre hospitalier universitaire de Haut Leveque | Recruiting |
| Pessac, Gironde, France, 33604 | |
| Contact 33557656483 | |
| Principal Investigator: Jean-François Viallard | |
| 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 | Recruiting |
| Montpellier Cedex 5, France, 34295 | |
| Contact 33467336135 | |
| Principal Investigator: Jacques Morel | |
| Hôpital de HautePierre | Recruiting |
| Strasbourg, France, 67098 | |
| Contact 33388127688 | |
| Principal Investigator: Jacques-Eric Gottenberg | |
| India | |
| Krishna Institute of Medical Sciences Ltd. | Suspended |
| Hyderabad, Andhra Pradesh, India, 500003 | |
| Panchshil Hospital | Suspended |
| Ahmedabad, Gujarat, India, 380005 | |
| CIMS Hospital Private Limited | Suspended |
| Ahmedabad, Gujarat, India, 380060 | |
| NHL Municipal Medical College & VS General Hospital | Suspended |
| Ahmedabad, Gujarat, India, 38006 | |
| Shree Giriraj Hospital | Suspended |
| Rajkot, Gujarat, India, 360004 | |
| Nirmal Hospital Private Limited | Suspended |
| Surat, Gujarat, India, 395002 | |
| Sterling Hospital | Suspended |
| Vadodara, Gujarat, India, 390007 | |
| St. John Medical College & Hospital | Suspended |
| Bangalore, Karnataka, India, 560034 | |
| Chanre Rheumatology & Immunology Center & Research | Suspended |
| Bangalore, Karnataka, India, 560079 | |
| Sushruta Multispecialty Hospital & Research Center Pvt Ltd | Suspended |
| Hubli, Karnataka, India, 580021 | |
| Kasturba Medical College Hospital, Mangalore | Suspended |
| Madhav Nagar, Manipal, Karnataka, India, 576104 | |
| Jasleen Hospital | Suspended |
| Nagpur, Maharashtra, India, 44012 | |
| Synexus Affiliate - Sujata Birla Hospital & Medical Research Center | Suspended |
| Nashik, Maharashtra, India, 422101 | |
| Fortis Escorts Hospital | Suspended |
| Jaipur, Rajasthan, India, 302017 | |
| Post Graduate Institute of Medical Education & Research | Suspended |
| Chandigarh, India, 160012 | |
| Italy | |
| Azienda Ospedaliera Universitaria | Recruiting |
| Modena, MO, Italy, 41124 | |
| Contact 390522295684 | |
| Principal Investigator: CARLO SALVARANI | |
| Azienda Ospedaliera - Universitaria Pisana | Recruiting |
| Pisa, Toscana, Italy, 56100 | |
| Contact 39050558603 | |
| Principal Investigator: Marta Mosca | |
| IRCCS Ospedale Policlinico San Martino | Recruiting |
| Genova, Italy, 16132 | |
| Contact 390103537994 | |
| Principal Investigator: Maurizio Cutolo | |
| Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico | 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 | 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 | |
| Jp Red Cross Society Himeji Hp | Recruiting |
| Himeji, Hyogo, Japan, 670-8540 | |
| Contact 0792942251 | |
| Principal Investigator: Hidetoshi Kagawa | |
| 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 Med C | Recruiting |
| Meguro-ku, Tokyo, Japan, 153-8515 | |
| Contact 81120360605 | |
| Principal Investigator: Hideto Kameda | |
| Showa University Hospital | Recruiting |
| Shinagawa-ku, Tokyo, Japan, 142-8666 | |
| Contact 81337848000 | |
| Principal Investigator: Takeo Isozaki | |
| 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 | |
| Kyung Pook National University Hospital | Recruiting |
| Daegu, Korea, Korea, Republic of, 41944 | |
| Contact 82534205495 | |
| Principal Investigator: Young Mo Kang | |
| Chungnam National University Hospital | Recruiting |
| Daejeon, Korea, Korea, Republic of, 35015 | |
| Contact 82422808712 | |
| Principal Investigator: Seung Cheol Shim | |
| 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 | Recruiting |
| Seocho-Gu, Seoul, Korea, Republic of, 06591 | |
| Contact 82222586011 | |
| Principal Investigator: Sunghwan Park | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 05505 | |
| Contact 82230103280 | |
| Principal Investigator: Chang Keun Lee | |
| Philippines | |
| Mary Mediatrix Medical Center | Suspended |
| Lipa, Batangas, Philippines, 4217 | |
| Cebu Doctors Hospital | Suspended |
| Cebu City, Cebu, Philippines, 6000 | |
| Southern Philippines Medical Center | Suspended |
| Davao, Davao Del Norte, Philippines, 8000 | |
| Angeles University Foundation and Medical Center | Suspended |
| Angeles City, Pampanga, Philippines, 2009 | |
| Chong Hua Medical Arts Center | Suspended |
| Cebu City, Philippines, 6000 | |
| Makati Medical Center | Suspended |
| Makati City, Philippines, 1229 | |
| St. Luke's Medical Center | Suspended |
| Quenzon City, Philippines, 1102 | |
| 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 | Recruiting |
| Lublin, Polska, Poland, 20582 | |
| Contact 48814736948 | |
| 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 | |
| Malopolskie Centrum Medyczne S.C. | Recruiting |
| Krakow, Poland, 30-510 | |
| Contact 48122954140 | |
| Principal Investigator: Mariusz Korkosz | |
| Centrum Medyczne Plejady | Recruiting |
| Krakow, Poland, 30363 | |
| Contact +48514708177 | |
| Principal Investigator: Magdalena Celinska-Lowenhoff | |
| Lecznica MAK-MED, NZOZ | Recruiting |
| Nadarzyn, Poland, 05-830 | |
| Contact 48468552011 | |
| Principal Investigator: Marek Krogulec | |
| Twoja Przychodnia-Centrum Medyczne Nowa Sol | Recruiting |
| Nowa Sol, Poland, 67-100 | |
| Contact 48603940889 | |
| Principal Investigator: Malgorzata Miakisz | |
| Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu | Recruiting |
| Poznan, Poland, 61-545 | |
| Contact 48618310281 | |
| Principal Investigator: Wlodzimierz Samborski | |
| Reumatika Centrum Reumatologii | Recruiting |
| Warszawa, Poland, 02-691 | |
| Contact 48224895428 | |
| Principal Investigator: Anna Zubrzycka-Sienkiewicz | |
| Centrum Medyczne AMED | 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 | |
| Craiova Emergency Clinical County Hospital | Recruiting |
| Craiova, Dolj, Romania, 200642 | |
| Contact 40742060999 | |
| Principal Investigator: Florentin Vreju | |
| Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL | Recruiting |
| Brasov, Romania, 500283 | |
| Contact 40723237553 | |
| Principal Investigator: Anca Ioana Purcaru | |
| Euroclinic Hospital | Recruiting |
| Bucharest, Romania, 014461 | |
| Contact 40724574671 | |
| Principal Investigator: Horia Chicos | |
| SANA Medical Center | Recruiting |
| Bucharest, Romania, 11025 | |
| Contact 40723698925 | |
| Principal Investigator: Cristina Pop | |
| St. Maria Clinical Hospital | Recruiting |
| Bucharest, Romania, 11172 | |
| Contact 40723236258 | |
| Principal Investigator: Florian Berghea | |
| 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 381113615552 | |
| Principal Investigator: Dusan Skiljevic | |
| Clinical Center of Serbia | Recruiting |
| Belgrade, Serbia, 11000 | |
| Contact 381113663222 | |
| Principal Investigator: Aleksandra Peric-Popadic | |
| 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: Branislava Glisic | |
| 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 | |
| Suite 509 Umhlanga Netcare Medical Centre | Suspended |
| Umhlanga, Durban, South Africa, 4319 | |
| Charlotte Maxeke Johannesburg Academic Hospital | Suspended |
| Parktown, Guateng, South Africa, 2000 | |
| Vincent Palloti Hospital-Dick Williamson Med Center | Suspended |
| Cape Town, Western Cape, South Africa, 7405 | |
| Panorama Medical Centre | Suspended |
| Cape Town, Western Cape, South Africa, 7506 | |
| Winelands Medical Research Centre | Suspended |
| Stellenbosch, Western Cape, South Africa, 7600 | |
| Suite 209A Jakaranda Hospital | Suspended |
| Pretoria, South Africa, 0002 | |
| University Of Pretoria | Suspended |
| Pretoria, South Africa, 0002 | |
| 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 | |
| Corporacion 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 |
| 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: | August 5, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement. |
| 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 |