A Study of Baricitinib in Participants With Systemic Lupus Erythematosus
Study Purpose
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).
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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.
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.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03616964 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eli Lilly and Company |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
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) |
| Principal Investigator Affiliation | Eli Lilly and Company |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Chile, Colombia, France, India, Italy, Japan, Korea, Republic of, Philippines, Poland, Romania, Serbia, South Africa, Spain, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Systemic Lupus Erythematosus |
| Study Website: | View Trial Website |
Arms
Experimental: Baricitinib High Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Experimental: Baricitinib Low Dose
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Placebo Comparator: Placebo
Placebo administered orally.
Interventions
Drug: - Baricitinib
Administered orally.
Drug: - Placebo
Administered orally
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Completed
Address
University of Arizona Arthritis Center
Gilbert, Arizona, 85297
Status
Active, not recruiting
Address
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85302
Status
Active, not recruiting
Address
Arizona Arthritis & Rheumatology Associates, P. C.
Tucson, Arizona, 85704
Status
Active, not recruiting
Address
Wallace Rheumatic Studies Center
Beverly Hills, California, 90211
Status
Active, not recruiting
Address
Medvin Clinical Research - Weidmann
Covina, California, 91722
Status
Active, not recruiting
Address
Office: Dr Robin K Dore
Tustin, California, 92780
Status
Active, not recruiting
Address
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, 91786
Status
Active, not recruiting
Address
Denver Arthritis Clinic - Lowry
Denver, Colorado, 80230
Status
Active, not recruiting
Address
Clinical Research of West Florida
Clearwater, Florida, 33765
Status
Active, not recruiting
Address
Millennium Research
Ormond Beach, Florida, 32174
Status
Active, not recruiting
Address
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324
Status
Active, not recruiting
Address
Clinical Research of West Florida
Tampa, Florida, 33603
Status
Active, not recruiting
Address
Tampa Medical Group, P.A.
Tampa, Florida, 33614
Status
Active, not recruiting
Address
Emory University
Atlanta, Georgia, 30322
Status
Completed
Address
Northside Hospital
Atlanta, Georgia, 30342
Status
Active, not recruiting
Address
North Georgia Rheumatology, PC
Lawrenceville, Georgia, 30046
Status
Active, not recruiting
Address
Arthritis Center of Lexington
Lexington, Kentucky, 40504
Status
Active, not recruiting
Address
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224-6801
Status
Active, not recruiting
Address
Advanced Rheumatology, PC
Lansing, Michigan, 48910
Status
Completed
Address
Glacier View Research Institute - Endocrinology
Kalispell, Montana, 59901
Status
Recruiting
Address
Innovative Health Research
Las Vegas, Nevada, 89128
Status
Completed
Address
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Status
Active, not recruiting
Address
Arthritis and Osteoporosis Associates of New Mexico
Las Cruces, New Mexico, 88011
Status
Active, not recruiting
Address
St. Lawrence Health System
Canton, New York, 13617
Status
Active, not recruiting
Address
New York University Medical Center
New York, New York, 10016
Status
Active, not recruiting
Address
SUNY Upstate Medical University
Syracuse, New York, 13210
Status
Active, not recruiting
Address
Joint and Muscle Medical Care
Charlotte, North Carolina, 28204
Status
Active, not recruiting
Address
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte, North Carolina, 28210
Status
Active, not recruiting
Address
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, 45242
Status
Active, not recruiting
Address
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Status
Active, not recruiting
Address
Clinical Research Center of Reading,LLC
Wyomissing, Pennsylvania, 19610
Status
Active, not recruiting
Address
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
Summerville, South Carolina, 29486
Status
Active, not recruiting
Address
Eagle Medical
Crossville, Tennessee, 38555
Status
Active, not recruiting
Address
Dr. Dhiman Basu Private Practice
Colleyville, Texas, 76034
Status
Active, not recruiting
Address
Metroplex Clinical Research Center
Dallas, Texas, 75231
Status
Active, not recruiting
Address
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382
Status
Active, not recruiting
Address
Clear Lake Specialties
Webster, Texas, 77598
Status
Active, not recruiting
Address
Arthritis Clinic of Northern VA, P.C.
Arlington, Virginia, 22205
Status
Active, not recruiting
Address
Spectrum Medical Inc.
Danville, Virginia, 24541
International Sites
Status
Active, not recruiting
Address
Aprillus Asistencia e Investigacion - Servicio de neurologia
Caba, Buenos Aires, C1046AAQ
Status
Active, not recruiting
Address
DOM Centro de Reumatologia
Ciudad de Buenos Aires, Buenos Aires, C1111AAH
Status
Active, not recruiting
Address
Framingham Centro Medico
La Plata, Buenos Aires, B1902COS
Status
Active, not recruiting
Address
CER Instituto Medico
Quilmes, Buenos Aires, B1878DVC
Status
Active, not recruiting
Address
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, B1878GEG
Status
Active, not recruiting
Address
Comite de Etica en Investigacion - CEMIC
Buenos Aires, Ciudad Autonoma De Buenos Aire, C1431FWO
Status
Active, not recruiting
Address
Clinica Adventista Belgrano
Caba, Ciudad Autónoma De Buenos Aire, C1430EGF
Status
Active, not recruiting
Address
Sanatorio Británico
Rosario, Santa Fe, 2000
Status
Active, not recruiting
Address
Centro Medico Privado de Reumatologia
SAN M. DE Tucuman, Tucumán, T4000AXL
Status
Completed
Address
Sanatorio Guemes Cardiocirugia
Ciudad Autonoma Buenos Aires, , C1181AAX
Status
Active, not recruiting
Address
IR Medical Center S.A. Instituto de Reumatologia
Mendoza, , M5500CPH
Status
Active, not recruiting
Address
Clinical Research Chile SpA
Valdivia, Los Ríos, 5110683
Status
Active, not recruiting
Address
Enroll SpA
Providencia, Región Metropolitana De Santia, 7500587
Status
Active, not recruiting
Address
Clinica Alemana de Osorno
Osorno, , 5290000
Status
Active, not recruiting
Address
Sociedad Medica Del Aparato Locomotor SA
Santiago, , 7510186
Status
Active, not recruiting
Address
Prosalud y cia. Ltda.
Santiago, ,
Status
Active, not recruiting
Address
ReumaCen Centro Reumatologico Integral
Vina del Mar, , 2570017
Status
Active, not recruiting
Address
HPTU-El Hospital con alma Pablo Tobon Uribe
Medellin, Antioquia,
Status
Active, not recruiting
Address
Clinica de la Costa
Barranquilla, Atlantico,
Status
Active, not recruiting
Address
Circaribe SAS
Barranquilla, Atlántico,
Status
Active, not recruiting
Address
Idearg S.A.S.
Bogota, Cundinamarca,
Status
Active, not recruiting
Address
Centro Integral de Reumatologia e Inmunologia
Bogotá, Cundinamarca,
Status
Active, not recruiting
Address
Servimed S.A.S.
Bucaramanga, Santander, 12345
Status
Active, not recruiting
Address
Centro de Medicina Interna
Cali, Valle Del Cauca,
Status
Active, not recruiting
Address
Preventive Care Ltdac
Chia, ,
Status
Active, not recruiting
Address
CHRU Brest - Hopital Cavale Blanche
Brest Cedex, Finistère, 29609
Status
Completed
Address
Centre hospitalier universitaire de Haut Leveque
Pessac, Gironde, 33604
Status
Active, not recruiting
Address
CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault, 34295
Status
Active, not recruiting
Address
Centre hospitalier universitaire Pellegrin
Bordeaux, , 33076
Status
Active, not recruiting
Address
Hopital Européen
Marseille, , 13003
Status
Active, not recruiting
Address
Krishna Institute of Medical Science
Hyderabad, Andhra Pradesh, 500003
Status
Active, not recruiting
Address
Panchshil Hospital
Ahmedabad, Gujarat, 380005
Status
Active, not recruiting
Address
CIMS Hospital Private Limited
Ahmedabad, Gujarat, 380060
Status
Completed
Address
NHL Municipal Medical College & VS General Hospital
Ahmedabad, Gujarat, 38006
Status
Completed
Address
Shree Giriraj Hospital
Rajkot, Gujarat, 360004
Status
Active, not recruiting
Address
Nirmal Hospital Private Limited
Surat, Gujarat, 395002
Status
Active, not recruiting
Address
Sterling Hospital
Vadodara, Gujarat, 390007
Status
Active, not recruiting
Address
St. John Medical College & Hospital
Bangalore, Karnataka, 560034
Status
Active, not recruiting
Address
ChanRe Rheumatology And Immunology Center And Research
Bangalore, Karnataka, 560079
Status
Active, not recruiting
Address
Sushruta Multispecialty Hospital & Research Center Pvt Ltd
Hubli, Karnataka, 580021
Status
Active, not recruiting
Address
Kasturba Medical College Hospital, Mangalore
Madhav Nagar, Manipal, Karnataka, 576104
Status
Active, not recruiting
Address
Jasleen Hospital
Nagpur, Maharashtra, 44012
Status
Active, not recruiting
Address
Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
Nashik, Maharashtra, 422101
Status
Active, not recruiting
Address
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017
Status
Active, not recruiting
Address
Azienda Ospedaliera Universitaria
Modena, MO, 41124
Status
Active, not recruiting
Address
Azienda Ospedaliera Universitaria Pisana
Pisa, Toscana, 56100
Status
Active, not recruiting
Address
IRCCS Ospedale Policlinico San Martino
Genova, , 16132
Status
Active, not recruiting
Address
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milano, , 20122
Status
Active, not recruiting
Address
Azienda Policlinico Umberto I
Roma, , 00161
Status
Active, not recruiting
Address
Azienda Ospedaliera Santa Maria Della Misericordia
Udine, , 33100
Status
Active, not recruiting
Address
University of Occupational and Enviromental Health
Kitakyushu, Fukuoka, 807-8556
Status
Active, not recruiting
Address
Hiroshima University Hospital
Hiroshima-shi, Hiroshima-ken, 734-8551
Status
Active, not recruiting
Address
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, 070-8644
Status
Active, not recruiting
Address
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Status
Active, not recruiting
Address
Jp Red Cross Society Himeji Hp
Himeji, Hyogo, 670-8540
Status
Active, not recruiting
Address
Kobe University Hospital
Kobe, Hyogo, 650-0017
Status
Active, not recruiting
Address
Kagawa University Hospital
Kita-gun, Kagawa, 761-0793
Status
Active, not recruiting
Address
Tohoku University Hospital
Sendai-shi, Miyagi, 980-8574
Status
Active, not recruiting
Address
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Status
Active, not recruiting
Address
St. Lukes International Hospital
Chuo-Ku, Tokyo, 104 8560
Status
Active, not recruiting
Address
Toho University Ohashi Med C
Meguro-ku, Tokyo, 153-8515
Status
Completed
Address
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666
Status
Active, not recruiting
Address
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582
Status
Active, not recruiting
Address
National Hospital Organization Kyushu Medical Center
Fukuoka, , 810 8563
Status
Completed
Address
Hamanomachi Hospital
Fukuoka, , 810-8539
Status
Active, not recruiting
Address
Nippon Medical School Hospital
Tokyo, , 113-8603
Status
Recruiting
Address
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Status
Active, not recruiting
Address
Kyung Pook National University Hospital
Daegu, Korea, 41944
Status
Active, not recruiting
Address
Gachon University Gil Medical Center
Incheon, Korea, 21565
Status
Active, not recruiting
Address
Hanyang University Medical Center
Seoul, Korea, 04763
Status
Active, not recruiting
Address
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu, Seoul, 06591
Status
Active, not recruiting
Address
Asan Medical Center
Seoul, , 05505
Status
Active, not recruiting
Address
Mary Mediatrix Medical Center
Lipa, Batangas, 4217
Status
Active, not recruiting
Address
Cebu Doctors Hospital
Cebu City, Cebu, 6000
Status
Active, not recruiting
Address
Southern Philippines Medical Center
Davao, Davao Del Norte, 8000
Status
Active, not recruiting
Address
Angeles University Foundation and Medical Center
Angeles City, Pampanga, 2009
Status
Active, not recruiting
Address
Chong Hua Medical Arts Center
Cebu City, , 6000
Status
Active, not recruiting
Address
Makati Medical Center
Makati City, , 1229
Status
Active, not recruiting
Address
St. Luke's Medical Center
Quenzon City, , 1102
Status
Active, not recruiting
Address
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
Wroclaw, Dolnoslaskie, 53224
Status
Active, not recruiting
Address
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sol, Lubuskie, 67-100
Status
Active, not recruiting
Address
Medycyna Kliniczna
Warszawa, Mazowieckie, 00874
Status
Active, not recruiting
Address
Centrum Medyczne Reuma Park
Warszawa, Mazowieckie, 02-691
Status
Active, not recruiting
Address
Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
Bialystok, Podlaskie, 15-077
Status
Active, not recruiting
Address
Zespol Poradni Specjalistycznych REUMED
Lublin, Polska, 20582
Status
Active, not recruiting
Address
Ambulatorium Sp. z o. o.
Elblag, Warminsko-Mazurki, 82300
Status
Active, not recruiting
Address
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, , 85-168
Status
Active, not recruiting
Address
Centrum Medyczne Pratia Katowice
Katowice, , 40-081
Status
Active, not recruiting
Address
Malopolskie Centrum Medyczne S.C.
Krakow, , 30-510
Status
Active, not recruiting
Address
Centrum Medyczne Plejady
Krakow, , 30363
Status
Active, not recruiting
Address
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, , 05-830
Status
Completed
Address
Ortopedyczno-Rehabilitacyjny Szpital Kliniczny UM w Poznaniu
Poznan, , 61-545
Status
Active, not recruiting
Address
Centrum Medyczne AMED
Warszawa, , 03-291
Status
Active, not recruiting
Address
Napoca Emergency Clinical County Hospital
Napoca, Cluj, 40006
Status
Active, not recruiting
Address
Craiova Emergency Clinical County Hospital
Craiova, Dolj, 200642
Status
Active, not recruiting
Address
C.M.D.T.A. Neomed
Brasov, , 500283
Status
Active, not recruiting
Address
SANA Medical Center
Bucharest, , 11025
Status
Active, not recruiting
Address
St. Maria Clinical Hospital
Bucharest, , 11172
Status
Active, not recruiting
Address
Spitalul Clinic Sf Maria Bucuresti
Bucuresti, , 011172
Status
Completed
Address
Spitalul Clinic "Dr. Ioan Cantacuzino"
Bucuresti, , 020475
Status
Active, not recruiting
Address
Spitalul Euroclinic
Bucureti, , 014461
Status
Active, not recruiting
Address
Clinical Center of Serbia
Belgrade, , 11000
Status
Active, not recruiting
Address
Institute of Rheumatology
Belgrade, , 11000
Status
Active, not recruiting
Address
Military Medical Academy
Belgrade, , 11000
Status
Active, not recruiting
Address
Institute for Treatment and Rehabilitation Niska Banja
Niska Banja, , 18205
Status
Active, not recruiting
Address
Clinical Center of Vojvodina
Novi Sad, , 21000
Status
Active, not recruiting
Address
Suite 509 Umhlanga Netcare Medical Centre
Umhlanga, Durban, 4319
Status
Active, not recruiting
Address
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Guateng, 2000
Status
Active, not recruiting
Address
Jakaranda Hospital
Muckleneuk, Pretoria, 0002
Status
Active, not recruiting
Address
Panorama Medical Centre
Cape Town, Western Cape, 7506
Status
Active, not recruiting
Address
Arthritis Clinical Trial Centre
Pinelands, Western Cape, 7405
Status
Active, not recruiting
Address
Winelands Medical Research Centre
Stellenbosch, Western Cape, 7600
Status
Active, not recruiting
Address
University Of Pretoria
Pretoria, , 0002
Status
Active, not recruiting
Address
Hospital Marina Baixa
La Vila Joiosa, Alicante, 03570
Status
Active, not recruiting
Address
Hospital De Fuenlabrada
Fuenlabrada, Madrid, 28944
Status
Active, not recruiting
Address
Hospital do Meixoeiro
Vigo, Pontevedra, 36200
Status
Active, not recruiting
Address
Corporacion Sanitaria Parc Tauli
Sabadell, Sapin, 08208
Status
Active, not recruiting
Address
Hospital Universitari Vall d'Hebron
Barcelona, , 08035
Status
Active, not recruiting
Address
Corporació Sanitària Clínic
Barcelona, , 8036
Status
Active, not recruiting
Address
Hospital Quiron Infanta Luisa
Sevilla, , 41010
