A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) (SLE-BRAVE-X)
May 12, 2023 updated by: Eli Lilly and Company
A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)
The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1147
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, C1431FWO
- Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)
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Mendoza, Argentina, M5500CPH
- IR Medical Center S.A. Instituto de Reumatologia
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Tucumán, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman
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Buenos Aires
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Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1046
- Aprillus Asistencia e Investigacion de Arcis Salud SRL
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Ciudad de Buenos Aires, Buenos Aires, Argentina, C1111AAH
- DOM Centro de Reumatología
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La Plata, Buenos Aires, Argentina, B1902COS
- Framingham Centro Medico
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Quilmes, Buenos Aires, Argentina, B1878DVC
- Cer Instituto Medico
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Quilmes, Buenos Aires, Argentina, B1878GEG
- Instituto de Investigaciones Clinicas Quilmes
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Ciudad Autónoma De Buenos Aire
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Caba, Ciudad Autónoma De Buenos Aire, Argentina, C1430EGF
- Clinica Adventista Belgrano
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Santa Fe
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Rosario, Santa Fe, Argentina, 2000
- Sanatorio Britanico
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New South Wales
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Botany, New South Wales, Australia, 2019
- Optimus Clinical Research
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Queensland
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Maroochydore, Queensland, Australia, 4558
- The Rheumatology Research Unit Sunshine Coast
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Victoria
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Camberwell, Victoria, Australia, 3124
- Emeritus Research
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Fitzroy, Victoria, Australia, 3065
- St. Vincent's Hospital
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Graz, Austria, 8036
- MEDIZINISCHE UNIVERSITAT GRAZ
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Oberösterreich
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Linz, Oberösterreich, Austria, 4020
- A O Krankenhaus der Elisabethinen
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgium, 3000
- UZ Leuven
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Cuiaba, Brazil, 78043-142
- Oncovida- Centro de Onco-Hematologia de Mato Grosso
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Bahia
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Salvador, Bahia, Brazil, 40150-150
- SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
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MG
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Belo Horizonte, MG, Brazil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Paraná
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Curitiba, Paraná, Brazil, 80030-110
- Centro de Estudos em Terapias Inovadoras-CETI
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Curitiba, Paraná, Brazil, 80440-080
- EDUMED - Educação em Saúde Ltda.
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90540-000
- LMK Serviços Médicos S/S
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SP
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Campinas, SP, Brazil, 13083-970
- Hospital de Clinicas UNICAMP
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Osorno, Chile, 5290000
- Clinica Alemana de Osorno
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Santiago, Chile, 7510186
- Sociedad Medica Del Aparato Locomotor SA
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Santiago, Chile
- Prosalud y cia. Ltda.
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Vina del Mar, Chile, 2570017
- CINVEC- Estudos Clínicos Quinta Región Limitada
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Los Ríos
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Valdivia, Los Ríos, Chile, 5110683
- Clinical Research Chile SpA
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Región Metropolitana De Santia
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Providencia, Región Metropolitana De Santia, Chile, 7500587
- Enroll Spa
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Beijing, China, 100034
- Peking University First Hospital
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Beijing, China, 100730
- Beijing Peking Union Medical College Hospital
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Shanghai, China, 200040
- Shanghai Huashan Hospital Affil to Fu Dan University
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Shenyang, China, 110001
- China Medical University (CMU) - First Affiliated Hospital
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Suzhou Shi, China, 215000
- The First Affliated Hospital of Suzhou University
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Zhengzhou, China, 450000
- The First Affiliated Hospital of Zhengzhou Universtiy
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Guangdong
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Guangzhou, Guangdong, China, 510080
- First Affiliated Hospital of Sun Yat-sen University
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Heilongjiang
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Harbin, Heilongjiang, China, 150001
- First Affiliated Hospital of the Harbin Medical University
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Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Union Hospital
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Jiangsu
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Nanjing, Jiangsu, China, 210000
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Jiangxi
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Pingxiang, Jiangxi, China, 337000
- Pingxiang People's Hospital
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Jilin
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Changchun, Jilin, China, 130033
- China-Japan Union Hospital, CJUH.
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Shanghai
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Shanghai, Shanghai, China, 200032
- Zhongshan Hospital, Fudan University
-
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Tianjin
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Tianjin, Tianjin, China, 300052
- Tianjin Medical University General Hospital
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Xinjiang
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Urumqi, Xinjiang, China, 830001
- People's Hospital of Xinjiang Uygur Autonomous Region
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- The Second Affiliated hospital of Zhejiang University school of medicine
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Ningbo, Zhejiang, China, 315010
- Ningbo First Hospital
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Chia, Colombia
- Preventive Care Ltdac
-
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Antioquia
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Medellin, Antioquia, Colombia
- HPTU-El Hospital con alma Pablo Tobon Uribe
-
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Atlantico
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Barranquilla, Atlantico, Colombia, 080020
- Clinica de la Costa
-
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Atlántico
-
Barranquilla, Atlántico, Colombia
- Circaribe SAS
-
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Cundinamarca
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Bogota, Cundinamarca, Colombia
- Idearg S.A.S.
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Santander
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Bucaramanga, Santander, Colombia, 12345
- Servimed S.A.S.
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia
- Centro de Medicina Interna
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-
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Rijeka, Croatia, 51000
- Klinicki bolnicki centar Rijeka
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Split, Croatia, 21000
- University Hospital Split
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-
-
-
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Brno, Czechia, 638 00
- Revmatologie.s.r.o.
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Olomouc, Czechia, 775 20
- Fakultni Nemocnice Olomouc
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Pardubice, Czechia, 53002
- Arthrohelp S.R.O.
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Praha 2, Czechia, 128 08
- VFN a 1 LF University Karlovy
-
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Praha, Hlavní Mešto
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Praha 2, Praha, Hlavní Mešto, Czechia, 12850
- Revmatologicky Ustav
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Bordeaux, France, 33076
- Centre hospitalier universitaire Pellegrin
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Lille Cedex, France, 59037
- CHRU Lille - Hôpital Claude Huriez
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Marseille, France, 13003
- Hôpital Européen
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Strasbourg, France, 67098
- Hopital de Hautepierre
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Finistère
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Brest Cedex, Finistère, France, 29609
- CHRU Brest - Hôpital Cavale Blanche
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Berlin, Germany, 10117
- Charité Campus Virchow-Klinikum
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Berlin, Germany, 13125
- Immanuel Krankenhaus Rheuma Klinik Berlin Buch
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Berlin, Germany, 14059
- Schlosspark Klinik
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Köln, Germany, 50937
- Universitaetsklinikum Koeln
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Baden-Württemberg
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Freiburg, Baden-Württemberg, Germany, 79106
- Universitätsklinikum Freiburg
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Tübingen, Baden-Württemberg, Germany, 72076
- Universitätsklinikum Tübingen
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Bayern
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München, Bayern, Germany, 81337
- Klinikum der Universität München Großhadern
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Würzburg, Bayern, Germany, 97080
- Universitätsklinikum Würzburg A. ö. R.
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Germany, 55131
- Universitätsmedizin Johannes Gutenberg Universität Mainz
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Sachsen
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Dresden, Sachsen, Germany, 01307
- Universitätsklinikum Carl Gustav Carus
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Leipzig, Sachsen, Germany, 4103
- Universitätsklinikum Leipzig
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Larissa, Greece, 41 221
- Regional General University Hospital of Larissa
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Thessaloniki, Greece, 54636
- Kianous Stavros
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Thessaloniki, Greece, 54642
- Gen. Hosp. of Thessaloniki "Hippokration"
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Attiki
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Athens, Attiki, Greece, 11527
- Gen Hospital of Athens G Gennimatas
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Irakleío
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Heraklion, Irakleío, Greece, 711 10
- University General Hospital of Heraklion
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Budapest, Hungary, 1023
- Budai Irgalmasrendi Korhaz
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Budapest, Hungary, 1097
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
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Budapest, Hungary, 1036
- Qualiclinic
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Debrecen, Hungary, 4032
- Debreceni Egyetem Klinikai Kozpont
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Debrecen, Hungary, 4004
- Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
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Pecs, Hungary, 7632
- Pécsi Tudományegyetem Klinikai Központ
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Szeged, Hungary, 6725
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
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Székesfehérvár, Hungary, 8000
- Vita Verum Egeszsegugyi Szolgaltato Bt
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Békés
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Gyula, Békés, Hungary, 5700
- Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
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Veszprém City
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Veszprem, Veszprém City, Hungary, 8200
- Vital Medical Center
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Gujarat
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Ahmedabad, Gujarat, India, 380060
- CIMS Hospital Private Limited
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Ahmedabad, Gujarat, India, 380005
- Panchshil hospital
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Rajkot, Gujarat, India, 360004
- Shree Giriraj Hospital
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Surat, Gujarat, India, 395002
- Nirmal Hospital Private Limited
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Vadodara, Gujarat, India, 390007
- Sterling Hospital
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Karnataka
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Bangalore, Karnataka, India, 560010
- ChanRe Rheumatology And Immunology Center And Research
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Bangalore, Karnataka, India, 560034
- St. John Medical College & Hospital
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Hubli, Karnataka, India, 580021
- Sushruta Multispecialty Hospital & Research Center Pvt Ltd
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Madhav Nagar, Manipal, Karnataka, India, 576104
- Kasturba Medical College Hospital, Mangalore
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Maharashtra
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Nagpur, Maharashtra, India, 440012
- Jasleen Hospital
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Nashik, Maharashtra, India, 422101
- Synexus Affiliate - Sujata Birla Hospital & Medical Research Center
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Rajasthan
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Jaipur, Rajasthan, India, 302017
- Fortis Escorts Hospital
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Telengana
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Secunderabad, Telengana, India, 500003
- Krishna Institute Of Medical Science
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Ramat Gan, Israel, 5262000
- Sheba Medical Center
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Ḥeifā
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Haifa, Ḥeifā, Israel, 3436212
- Carmel Hospital
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Milano, Italy, 20122
- Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
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Pisa, Italy, 56126
- Azienda Ospedaliera Universitaria Pisana
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Roma, Italy, 00161
- Azienda Policlinico Umberto I
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Udine, Italy, 33100
- Azienda ospedaliera Santa Maria della Misericordia
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Fukuoka, Japan, 810-8539
- Hamanomachi Hospital
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Fukuoka, Japan, 810 8563
- National Hospital Organization Kyushu Medical Center
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Tokyo, Japan, 104-8560
- St. Luke's International Hospital
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Tokyo, Japan, 1600035
- Keio University Hospital
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Fukuoka
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Kitakyushu, Fukuoka, Japan, 807-8556
- University of Occupational and Enviromental Health
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Hokkaido
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Asahikawa, Hokkaido, Japan, 070-8644
- National Hospital Organization Asahikawa Medical Center
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Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
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Hyogo
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Himeji, Hyogo, Japan, 670-8540
- Jp Red Cross Society Himeji Hp
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Kobe, Hyogo, Japan, 650-0017
- Kobe University Hospital
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Kagawa
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Kita-gun, Kagawa, Japan, 761-0793
- Kagawa University Hospital
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Miyagi
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Sendai-shi, Miyagi, Japan, 980-8574
- Tohoku University Hospital
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Okinawa
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Tomigusuku, Okinawa, Japan, 901-0243
- Tomishiro Central Hospital
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Shizuoka
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Hamamatsu, Shizuoka, Japan, 430-8558
- Seirei Hamamatsu General Hospital
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Tokyo
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Bunkyo-Ku, Tokyo, Japan, 113-8603
- Nippon Medical School Hospital
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Juntendo University Hospital
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Shinagawa, Tokyo, Japan, 142-8555
- Showa University Hospital
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
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Korea
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Daegu, Korea, Korea, Republic of, 41944
- Kyung Pook National University Hospital
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Daejeon, Korea, Korea, Republic of, 35015
- Chungnam national university hospital
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Incheon, Korea, Korea, Republic of, 21565
- Gachon University Gil Hospital
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Seoul, Korea, Korea, Republic of, 06591
- Seoul St. Mary's Hospital
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Seoul, Korea, Korea, Republic of, 04763
- Hanyang University Medical Center
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Seoul, Korea, Korea, Republic of, 05505
- Asan Medical Center
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Ciudad De México, Mexico, 11850
- Centro de Investigación y Tratamiento Reumatológico S.C
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Mexico City, Mexico, 06760
- Clinosar Mexico S.A. de C.V
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Mexico City, Mexico, 07760
- Consultorio de Reumatologia
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Oaxaca, Mexico, 68000
- Oaxaca Site Management Organization
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Coahuila
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Torreon, Coahuila, Mexico, 27000
- Dr. Alberto Esteban Bazzoni Ruiz
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Distrito Federal
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Mexico City, Distrito Federal, Mexico, 06700
- Clinica para el Diagnostico y Tratamiento de la Enfermedades
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Guanajuato
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Leon, Guanajuato, Mexico, 37000
- Morales Vargas Centro de Investigacion, S.C.
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Jalisco
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Guadalajara, Jalisco, Mexico, 44160
- Centro Integral en Reumatologia SA de CV
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Guadalajara, Jalisco, Mexico, 44650
- Clinica de Investigacion en Reumatologia y Obesidad S. C.
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Guadalajara, Jalisco, Mexico, 44690
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
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Zapopan, Jalisco, Mexico, 45030
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
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SLP
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San Luis Potosi, SLP, Mexico, 78213
- Centro de Alta Especialidad Reumatologia Inv del Potosi SC
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Tabasco
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Villahermosa, Tabasco, Mexico, 89190
- Consultorio Jose Luis Garcia Figueroa
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Yucatan
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Merida, Yucatan, Mexico, 97070
- Köhler & Milstein Research
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Yucatán
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Merida, Yucatán, Mexico, 97130
- Cemdeicy S.C.P.
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Merida, Yucatán, Mexico, 97000
- Centro Peninsular de Investigacion S.C.P
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Amsterdam, Netherlands, 1081 HV
- Vrije Universiteit Medisch Centrum Amsterdam
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Fryslân
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Leeuwarden, Fryslân, Netherlands, 8934 AD
- Medische Centrum Leeuwarden
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Batangas
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Lipa, Batangas, Philippines, 4217
- Mary Mediatrix Medical Center
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Cebu
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Cebu City, Cebu, Philippines, 6000
- Cebu Doctors Hospital
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Cebu City, Cebu, Philippines, 6000
- Chong Hua Hospital
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Davao Del Norte
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Davao, Davao Del Norte, Philippines, 8000
- Southern Philippines Medical Center
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Luzon
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Makati, Luzon, Philippines, 1229
- Makati Medical Center
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Quezon City, Luzon, Philippines, 1102
- St. Luke's Medical Center
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Pampanga
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Angeles City, Pampanga, Philippines, 2009
- Angeles University Foundation and Medical Center
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Katowice, Poland, 40-081
- Centrum Medyczne Pratia Katowice
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Krakow, Poland, 30-510
- MCM Krakow - PRATIA - PPDS
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Krakow, Poland, 30363
- Centrum Medyczne Plejady
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Nadarzyn, Poland, 05-830
- NZOZ Lecznica MAK-MED s.c.
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Poznan, Poland, 61-545
- Klinika Reumatologii i Rehabilitacji
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Szczecin, Poland, 71-252
- Klinika Reumatologii, Chorob Wewnetrznych i Geriatrii PUM
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Warszawa, Poland, 03-291
- Centrum Medyczne AMED
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Dolnoslaskie
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Wroclaw, Dolnoslaskie, Poland, 53224
- Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
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Kujawsko-pomorskie
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Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
- Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej
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Lubuskie
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Nowa Sol, Lubuskie, Poland, 67-100
- Twoja Przychodnia Centrum Medyczne Nowa Sol
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Mazowieckie
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Warszawa, Mazowieckie, Poland, 00874
- Medycyna Kliniczna
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Warszawa, Mazowieckie, Poland, 02-691
- Reumatika - Centrum Reumatologii
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Podlaskie
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Bialystok, Podlaskie, Poland, 15-077
- Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk
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Polska
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Lublin, Polska, Poland, 20582
- Zespol Poradni Specjalistycznych REUMED
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Warminsko-Mazurki
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Elblag, Warminsko-Mazurki, Poland, 82300
- Ambulatorium Barbara Bazela
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Bucharest, Romania, 11025
- Sana Medical Center
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Bucuresti, Romania, 011172
- Spitalul Clinic Sf Maria Bucuresti
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Bucuresti, Romania, 020475
- Spitalul Clinic "Dr. Ioan Cantacuzino"
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Brașov
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Brasov, Brașov, Romania, 500283
- C.M.D.T.A. Neomed
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București
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Bucureti, București, Romania, 14461
- Spitalul Euroclinic
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Cluj
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Napoca, Cluj, Romania, 40006
- Napoca Emergency Clinical County Hospital
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Dolj
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Craiova, Dolj, Romania, 200642
- Craiova Emergency Clinical County Hospital
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Chelyabinsk, Russian Federation, 454076
- Chelyabinsk Regional Clinical Hospital
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Kazan, Russian Federation, 420103
- City Hospital # 7
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Moscow, Russian Federation, 115522
- V.A. Nasonova Research Institute of Rheumatology
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Moscow, Russian Federation, 117997
- Russian National Research Medical University n.a. N.I.Pirogov
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Moscow, Russian Federation, 119049
- City Clinical Hospital 1 named after N.I. Pirogov
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Novosibirsk, Russian Federation, 630099
- Research Institute of Clinical Immunology
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Novosibirsk, Russian Federation, 630117
- Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences
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Omsk, Russian Federation, 644111
- Regional Hospital - Omsk
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Orenburg, Russian Federation, 460018
- Orenburg State Medical Academy of Roszdrav
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Rursk, Russian Federation, 305007
- Kursk Regional Clinical Hospital
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Ryazan, Russian Federation, 390026
- Ryazan State Medical University
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Saint Petersburg, Russian Federation, 194044
- Russian Medical Military Academy n.a. S.M. Kirov
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Smolensk, Russian Federation, 214025
- Departmental Hospital at Smolensk Station "rzhd" JSC
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Ufa, Russian Federation, 450005
- Kuvatov Republican Clinical Hospital
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Zonova, Russian Federation, 630061
- LLC Medical Center Zdorovaya Semiya
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Moskva
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Moscow, Moskva, Russian Federation
- Moscow City Clinical Hospital Number 52
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Saint Petersburg
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St. Petersburg, Saint Petersburg, Russian Federation, 197372
- LLC MK Med
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Belgrade, Serbia, 11000
- Military Medical Academy
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Belgrade, Serbia, 11000
- Institute of Rheumatology
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Belgrade, Serbia, 11000
- University Clinical Center of Serbia
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Niska Banja, Serbia, 18205
- Institute for Treatment and Rehabilitation Niska Banja
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Novi Sad, Serbia, 21000
- Clinical Center of Vojvodina
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Pretoria, South Africa, 0002
- University Of Pretoria
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Durban
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Umhlanga, Durban, South Africa, 4319
- Suite 509 Umhlanga Netcare Medical Centre
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Gauteng
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Johannesburg, Gauteng, South Africa, 2193
- Wits Clinical Research
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Pretoria, Gauteng, South Africa, 0002
- Jakaranda Hospital
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Western Cape
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Cape Town, Western Cape, South Africa, 7405
- Vincent Pallotti Hospital
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Cape Town, Western Cape, South Africa, 7500
- Panorama Medical Centre
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Stellenbosch, Western Cape, South Africa, 7600
- Winelands Medical Research Centre
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Barcelona, Spain, 8036
- Corporacio Sanitaria Clinic
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Sevilla, Spain, 41010
- Hospital Quiron Infanta Luisa
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Alicante
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La Vila Joiosa, Alicante, Spain, 03570
- Hospital Marina Baixa
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Barcelona
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Sabadell, Barcelona, Spain, 08208
- Corporacion Sanitaria Parc Tauli
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Barcelona [Barcelona]
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Barcelona, Barcelona [Barcelona], Spain, 8035
- Hospital Universitari Vall d'Hebron
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Madrid
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Fuenlabrada, Madrid, Spain, 28944
- Hospital De Fuenlabrada
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Pontevedra
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Vigo, Pontevedra, Spain, 36200
- Hospital Do Meixoeiro
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Sankt Gallen
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st.Gallen, Sankt Gallen, Switzerland, 9007
- Cantonal Hospital St.Gallen
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Dalin Township, Taiwan, 622
- Hualien Tzu-Chi Hospital
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Kaohsiung, Taiwan, 81362
- Kaohsiung Veterans General Hospital
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Kaohsiung, Taiwan, 83301
- Chang Gung Memorial Hospital - Kaohsiung Branch
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
-
Tainan City, Taiwan, 71004
- Chi-Mei Medical Center
-
Taipei, Taiwan, 10002
- National Taiwan University Hospital
-
Taipei, Taiwan, 110
- Taipei Medical University Hospital
-
Taoyuan City, Taiwan, 33305
- Chang Gung Memorial Hospital - Linkou
-
-
-
-
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Doncaster, United Kingdom, DN2 5LT
- Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
-
Leeds, United Kingdom, LS7 4SA
- Leeds Teaching Hospital
-
-
Kent
-
Maidstone, Kent, United Kingdom, ME16 9QQ
- Maidstone Hospital
-
-
London
-
Leytonstone, London, United Kingdom, E11 1NR
- Whipps Cross University Hospital
-
Tooting, London, United Kingdom, SW17 0QT
- St George's Hospital
-
-
Surrey
-
London, Surrey, United Kingdom, SE1 9RT
- Guys/St. Thomas Hospital
-
-
-
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Alabama
-
Birmingham, Alabama, United States, 35216
- Achieve Clinical Research, LLC
-
-
Arizona
-
Phoenix, Arizona, United States, 85032
- Arizona Arthritis & Rheumatology Research
-
Tucson, Arizona, United States, 85704
- Arizona Arthritis & Rheumatology Associates, P. C.
-
-
California
-
Beverly Hills, California, United States, 90211
- Wallace Rheumatic Studies Center
-
Covina, California, United States, 91722
- Medvin Clinical Research - Weidmann
-
Fullerton, California, United States, 92835
- Providence Medical Foundation
-
Hemet, California, United States, 92543
- MD Medical Corporation
-
Poway, California, United States, 92064
- ACRC Studies
-
Upland, California, United States, 91786
- Inland Rheumatology & Osteoporosis Medical Group
-
Whittier, California, United States, 90602
- Medvin Clinical Research - Weidmann
-
-
Colorado
-
Denver, Colorado, United States, 80230
- Denver Arthritis Clinic - Lowry
-
-
Connecticut
-
Bridgeport, Connecticut, United States, 06606
- New England Research Associates
-
-
Florida
-
Aventura, Florida, United States, 33180
- Arthritis and Rheumatic Disease
-
Clearwater, Florida, United States, 33765
- Clinical Research of West Florida, Inc. (Clearwater)
-
Miami Lakes, Florida, United States, 33014
- Lakes Research, LLC
-
Ormond Beach, Florida, United States, 32174
- Millennium Research
-
Plantation, Florida, United States, 33324
- IRIS Research and Development, LLC
-
Plantation, Florida, United States, 33324
- Integral Rheumatology & Immunology Specialists
-
Tampa, Florida, United States, 33613-1244
- ForCare Clinical Research
-
Tampa, Florida, United States, 33614
- Tampa Medical Group, P.A.
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
Atlanta, Georgia, United States, 30318
- Piedmont Healthcare
-
Lawrenceville, Georgia, United States, 30046
- North Georgia Rheumatology, PC
-
-
Kentucky
-
Lexington, Kentucky, United States, 40504
- Arthritis Center of Lexington
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Asthma and Allergy Center
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Health System
-
Lansing, Michigan, United States, 48910
- Advanced Rheumatology, PC
-
Saint Clair Shores, Michigan, United States, 48081
- Clinical Research Institute of Michigan, LLC
-
-
Montana
-
Kalispell, Montana, United States, 59901
- Glacir View Research Institute
-
-
Nevada
-
Reno, Nevada, United States, 89519
- Allied Clinical Research
-
-
New Mexico
-
Las Cruces, New Mexico, United States, 88011
- Arthritis and Osteoporosis Associates of New Mexico
-
-
New York
-
Canton, New York, United States, 13617
- St. Lawrence Health System
-
Manhasset, New York, United States, 11030
- The Feinstein Institute for Medical Research
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
New York, New York, United States, 11201
- NYU Langone
-
Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28210
- Box Arthritis & Rheumatology of the Carolinas, PLLC
-
Charlotte, North Carolina, United States, 28204
- Joint and Muscle Medical Care
-
Greensboro, North Carolina, United States, 27408
- Medication Management
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Cincinnati Rheumatic Disease Study Group
-
Middleburg Heights, Ohio, United States, 44130
- Paramount Medical Research
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73102
- Arthritis & Rheumatology Center of Oklahoma PLLC
-
Oklahoma City, Oklahoma, United States, 73104-5046
- Oklahoma Medical Research Foundation
-
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Pennsylvania
-
Bethlehem, Pennsylvania, United States, 18015
- East Penn Rheumatology Associates
-
Wyomissing, Pennsylvania, United States, 19610
- Clinical Research Center of Reading,LLC
-
-
South Carolina
-
Summerville, South Carolina, United States, 29486
- Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
-
-
Tennessee
-
Crossville, Tennessee, United States, 38555
- Eagle Medical
-
Jackson, Tennessee, United States, 38305
- West Tennessee Research Institute
-
-
Texas
-
Amarillo, Texas, United States, 79124
- Amarillo Center for Clinical Research
-
Baytown, Texas, United States, 77521
- Accurate Clinical Management
-
Colleyville, Texas, United States, 76034
- Dr. Dhiman Basu Private Practice
-
Dallas, Texas, United States, 75231
- Metroplex Clinical Research Center
-
Fort Worth, Texas, United States, 76107
- Precision Comprehensive Clinical Research Solutions
-
Houston, Texas, United States, 77089
- Accurate Clinical Research
-
Houston, Texas, United States, 77004
- Rheumatology Center Of Houston
-
Mesquite, Texas, United States, 75150
- Southwest Rheumatology, P.A.
-
San Antonio, Texas, United States, 78229
- Accurate Clinical Research, Inc.
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The Woodlands, Texas, United States, 77382
- Advanced Rheumatology of Houston
-
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Virginia
-
Arlington, Virginia, United States, 22205
- Arthritis Clinic of Northern VA, P.C.
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Danville, Virginia, United States, 24541
- Spectrum Medical Inc.
-
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Wisconsin
-
Glendale, Wisconsin, United States, 53217
- Rheumatic Disease Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2 mg Baricitinib
Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).
|
Administered orally.
Administered orally.
Other Names:
|
|
Experimental: 4 mg Baricitinib
Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.
|
Administered orally.
Administered orally.
Other Names:
|
|
Experimental: Placebo to 2 mg Baricitinib
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.
|
Administered orally.
Administered orally.
Other Names:
|
|
Experimental: Placebo to 4 mg Baricitinib
Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
|
Administered orally.
Administered orally.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Week 134
|
Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
Week 134
|
|
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Time Frame: Week 134
|
Percentage of Participants with AESIs.
AESI consisted of infections, positively adjudicated arterial thromboembolic events (ATE), positively adjudicated venous thromboembolic events (VTE), positively adjudicated major adverse cardiovascular events (MACE), other positively adjudicated cardiovascular events, death, anaphylactic reactions, hypersensitivity, angioedema, and malignancies.
|
Week 134
|
|
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: Week 134
|
Percentage of participants with SAEs. An SAE is any AE from this study that results in one of the following outcomes: Death; Initial or prolonged inpatient hospitalization; A life-threatening experience (that is, immediate risk of dying); Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
Week 134
|
|
Percentage of Participants With Temporary Investigational Product Interruptions
Time Frame: Week 134
|
Percentage of participants with temporary investigational product interruptions.
|
Week 134
|
|
Percentage of Participants With Permanent Investigational Product Discontinuations
Time Frame: Week 134
|
Percentage of participants with permanent investigational product discontinuations.
|
Week 134
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response
Time Frame: Week 134
|
SRI-4 response defined as 1)greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assesses disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe). |
Week 134
|
|
Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
Time Frame: Week 48
|
Percentage of participants achieving a LLDAS.
The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity.
The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg daily.
|
Week 48
|
|
Change From Baseline in Prednisone Dose
Time Frame: Baseline through Week 48
|
Change from baseline in prednisone dose.
|
Baseline through Week 48
|
|
Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate
Time Frame: Baseline through Week 48
|
The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus.
A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia).
A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
The annualized flare rate is calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25.
|
Baseline through Week 48
|
|
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 48
|
The CLASI is a single-page tool that separately quantifies disease activity and damage.
For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia.
The total score represents the sum of the individual scores and ranges from 0 to 70.
Higher scores are awarded for more severe manifestations.
|
Week 48
|
|
Change From Baseline in Tender Joint Count
Time Frame: Baseline through Week 48
|
The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees.
The joints are assessed and classified as tender or not tender.
LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
|
Baseline through Week 48
|
|
Change From Baseline in Swollen Joint Count
Time Frame: Baseline trough Week 48
|
The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees.
The joints are assessed and classified as swollen or not swollen.
LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
|
Baseline trough Week 48
|
|
Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score
Time Frame: Baseline through Week 48
|
The SLICC/ACR damage index is a validated instrument to assess damage, defined as irreversible impairment, continuously persistent for 6 months (ascertained by clinical assessment), occurring since the onset of lupus, and it is based on a weighted scoring system.
This index records damage occurring in participants with SLE regardless of cause, with demonstrated content, face, criterion, and discriminant validity.
A score of 0 indicates no damage.
Total maximum score is 47 and increasing score indicates increasing disease severity.
|
Baseline through Week 48
|
|
Change From Baseline in Worst Pain Numeric Rating Scale (NRS)
Time Frame: Baseline through Week 48
|
Change from baseline in Worst Pain NRS.
It is assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable".
Overall severity of a patient's pain is indicated by selecting the number that best describes the worst level of pain during the past 7 days.
|
Baseline through Week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2019
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
February 14, 2019
First Submitted That Met QC Criteria
February 14, 2019
First Posted (Actual)
February 15, 2019
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 12, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16832
- I4V-MC-JAIM (Other Identifier: Eli Lilly and Company)
- 2017-005028-11 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.