A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus Clinical Trial

— SLE-BRAVE-X  

Official title:

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03843125
• Other study ID #: 16832
• Secondary ID: I4V-MC-JAIM2017-
• Status: Terminated
• Phase: Phase 3
• Start date: September 9, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1147
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have completed the final treatment study visit of an originating study, such as study JAHZ (NCT03616912) or Study JAIA (NCT03616964).

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Baricitinib
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Argentina	Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" (CEMIC)	Buenos Aires
Argentina	Clinica Adventista Belgrano	Caba	Ciudad Autónoma De Buenos Aire
Argentina	Aprillus Asistencia e Investigacion de Arcis Salud SRL	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	DOM Centro de Reumatologia	Ciudad de Buenos Aires	Buenos Aires
Argentina	Framingham Centro Medico	La Plata	Buenos Aires
Argentina	IR Medical Center S.A. Instituto de Reumatologia	Mendoza
Argentina	CER Instituto Medico	Quilmes	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas Quilmes	Quilmes	Buenos Aires
Argentina	Sanatorio Británico	Rosario	Santa Fe
Argentina	Centro de Investigaciones Médicas Tucuman	Tucumán
Australia	Optimus Clinical Research	Botany	New South Wales
Australia	Emeritus Research	Camberwell	Victoria
Australia	St. Vincent's Hospital	Fitzroy	Victoria
Australia	The Rheumatology Research Unit Sunshine Coast	Maroochydore	Queensland
Austria	Medizinische Universität Graz	Graz
Austria	A O Krankenhaus der Elisabethinen	Linz	Oberösterreich
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	UZ Leuven	Leuven	Vlaams Brabant
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte	MG
Brazil	Hospital de Clinicas UNICAMP	Campinas	SP
Brazil	Oncovida- Centro de Onco-Hematologia de Mato Grosso	Cuiaba
Brazil	Centro de Estudos em Terapias Inovadoras-CETI	Curitiba	Paraná
Brazil	EDUMED - Educação em Saúde Ltda.	Curitiba	Paraná
Brazil	LMK Serviços Médicos S/S	Porto Alegre	Rio Grande Do Sul
Brazil	SER - Serviços Especializados em Reumatologia da Bahia S/S - ME	Salvador	Bahia
Chile	Clinica Alemana de Osorno	Osorno
Chile	Enroll SpA	Providencia	Región Metropolitana De Santia
Chile	Prosalud y cia. Ltda.	Santiago
Chile	Sociedad Medica Del Aparato Locomotor SA	Santiago
Chile	Clinical Research Chile SpA	Valdivia	Los Ríos
Chile	CINVEC- Estudos Clínicos Quinta Región Limitada	Vina del Mar
China	Beijing Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	China-Japan Union Hospital, CJUH.	Changchun	Jilin
China	First affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	First Affiliated Hospital of the Harbin Medical University	Harbin	Heilongjiang
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Shanghai Huashan Hospital Affil to Fu Dan University	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	China Medical University (CMU) - First Affiliated Hospital	Shenyang
China	The First Affliated Hospital of Suzhou University	Suzhou Shi
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang
China	Wuhan Union Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Zhengzhou Universtiy	Zhengzhou
Colombia	Circaribe SAS	Barranquilla	Atlántico
Colombia	Clinica de la Costa	Barranquilla	Atlantico
Colombia	Idearg S.A.S.	Bogota	Cundinamarca
Colombia	Servimed S.A.S.	Bucaramanga	Santander
Colombia	Centro de Medicina Interna	Cali	Valle Del Cauca
Colombia	Preventive Care Ltdac	Chia
Colombia	HPTU-El Hospital con alma Pablo Tobon Uribe	Medellin	Antioquia
Croatia	Klinicki Bolnicki Centar Rijeka	Rijeka
Croatia	University Hospital Split	Split
Czechia	Revmatologie.s.r.o.	Brno
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	ARTHROHELP s.r.o.	Pardubice
Czechia	Revmatologicky ustav	Praha 2	Praha, Hlavní Mešto
Czechia	VFN a 1 LF University Karlovy	Praha 2
France	Centre hospitalier universitaire Pellegrin	Bordeaux
France	CHRU Brest - Hopital Cavale Blanche	Brest Cedex	Finistère
France	CHRU Lille - Hopital Claude Huriez	Lille Cedex
France	Hopital Européen	Marseille
France	Hôpital de HautePierre	Strasbourg
Germany	Charité Campus Virchow-Klinikum	Berlin
Germany	Immanuel Krankenhaus Rheuma Klinik Berlin Buch	Berlin
Germany	Schlosspark Klinik	Berlin
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Universitätsklinikum Freiburg	Freiburg	Baden-Württemberg
Germany	Universitaetsklinikum Koeln	Köln
Germany	Universitatsklinikum Leipzig	Leipzig	Sachsen
Germany	Universitätsmedizin Johannes Gutenberg Universität Mainz	Mainz	Rheinland-Pfalz
Germany	Klinikum der Universität München Großhadern	München	Bayern
Germany	Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
Germany	Universitätsklinikum Würzburg A. ö. R.	Würzburg	Bayern
Greece	Gen Hospital of Athens G Gennimatas	Athens	Attiki
Greece	University General Hospital of Heraklion	Heraklion	Irakleío
Greece	Regional General University Hospital of Larissa	Larissa
Greece	Gen. Hosp. of Thessaloniki "Hippokration"	Thessaloniki
Greece	Kianous Stavros	Thessaloniki
Hungary	Budai Irgalmasrendi Korhaz	Budapest
Hungary	Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet	Budapest
Hungary	Qualiclinic	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum	Debrecen
Hungary	Békés Megyei Központi Kórház Pándy Kálmán Tagkórház	Gyula	Békés
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika	Szeged
Hungary	Vita Verum Egeszsegugyi Szolgaltato Bt	Székesfehérvár
Hungary	Vital Medical Center	Veszprem	Veszprém City
India	CIMS Hospital Private Limited	Ahmedabad	Gujarat
India	Panchshil hospital	Ahmedabad	Gujarat
India	ChanRe Rheumatology And Immunology Center And Research	Bangalore	Karnataka
India	St. John Medical College & Hospital	Bangalore	Karnataka
India	Sushruta Multispecialty Hospital & Research Center Pvt Ltd	Hubli	Karnataka
India	Fortis Escorts Hospital	Jaipur	Rajasthan
India	Kasturba Medical College Hospital, Mangalore	Madhav Nagar, Manipal	Karnataka
India	Jasleen Hospital	Nagpur	Maharashtra
India	Synexus Affiliate - Sujata Birla Hospital & Medical Research Center	Nashik	Maharashtra
India	Shree Giriraj Hospital	Rajkot	Gujarat
India	Krishna Institute of Medical Science	Secunderabad	Telengana
India	Nirmal Hospital Private Limited	Surat	Gujarat
India	Sterling Hospital	Vadodara	Gujarat
Israel	Carmel Hospital	Haifa	?eifa
Israel	Meir Medical Center	Kfar Saba
Israel	Sheba Medical Center	Ramat Gan
Italy	Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Azienda Policlinico Umberto I	Roma
Italy	Azienda Ospedaliera Santa Maria Della Misericordia	Udine
Japan	National Hospital Organization Asahikawa Medical Center	Asahikawa	Hokkaido
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Nippon Medical School Hospital	Bunkyo-Ku	Tokyo
Japan	Hamanomachi Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	Jp Red Cross Society Himeji Hp	Himeji	Hyogo
Japan	Hiroshima University Hospital	Hiroshima
Japan	Kagawa University Hospital	Kita-gun	Kagawa
Japan	University of Occupational and Enviromental Health	Kitakyushu	Fukuoka
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai-shi	Miyagi
Japan	Showa University Hospital	Shinagawa	Tokyo
Japan	Keio university hospital	Tokyo
Japan	St. Luke's International Hospital	Tokyo
Japan	Tomishiro Central Hospital	Tomigusuku	Okinawa
Korea, Republic of	Kyung Pook National University Hospital	Daegu	Korea
Korea, Republic of	Chungnam National University Hospital	Daejeon	Korea
Korea, Republic of	Gachon University Gil Hospital	Incheon	Korea
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul	Korea
Korea, Republic of	Hanyang University Medical Center	Seoul	Korea
Korea, Republic of	Seoul St. Mary's Hospital	Seoul	Korea
Mexico	Centro de Investigación y Tratamiento Reumatológico S.C	Ciudad De México
Mexico	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares	Guadalajara	Jalisco
Mexico	Centro Integral en Reumatologia SA de CV	Guadalajara	Jalisco
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S. C.	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion, S.C.	Leon	Guanajuato
Mexico	Cemdeicy S.C.P.	Merida	Yucatán
Mexico	Centro Peninsular de Investigacion S.C.P	Merida	Yucatán
Mexico	Köhler & Milstein Research	Merida	Yucatan
Mexico	Clinica para el Diagnostico y Tratamiento de la Enfermedades	Mexico City	Distrito Federal
Mexico	Clinosar Mexico S.A. de C.V	Mexico City
Mexico	Consultorio de Reumatologia	Mexico City
Mexico	Oaxaca Site Management Organization	Oaxaca
Mexico	Centro de Alta Especialidad Reumatologia Inv del Potosi SC	San Luis Potosi	SLP
Mexico	Dr. Alberto Esteban Bazzoni Ruiz	Torreon	Coahuila
Mexico	Consultorio Jose Luis Garcia Figueroa	Villahermosa	Tabasco
Mexico	Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.	Zapopan	Jalisco
Netherlands	Vrije Universiteit Medisch Centrum Amsterdam	Amsterdam
Netherlands	Medische Centrum Leeuwarden	Leeuwarden	Fryslân
Philippines	Angeles University Foundation and Medical Center	Angeles City	Pampanga
Philippines	Cebu Doctors Hospital	Cebu City	Cebu
Philippines	Chong Hua Hospital	Cebu City	Cebu
Philippines	Southern Philippines Medical Center	Davao	Davao Del Norte
Philippines	Mary Mediatrix Medical Center	Lipa	Batangas
Philippines	Makati Medical Center	Makati	Luzon
Philippines	St. Luke's Medical Center	Quezon City	Luzon
Poland	Gabinet Internistyczno- Reumatologiczny Piotr Adrian Klimiuk	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej	Bydgoszcz	Kujawsko-pomorskie
Poland	Ambulatorium Barbara Bazela	Elblag	Warminsko-Mazurki
Poland	Centrum Medyczne Pratia Katowice	Katowice
Poland	Centrum Medyczne Plejady	Krakow
Poland	MCM Krakow - PRATIA - PPDS	Krakow
Poland	Zespol Poradni Specjalistycznych REUMED	Lublin	Polska
Poland	NZOZ Lecznica MAK-MED s.c.	Nadarzyn
Poland	Twoja Przychodnia Centrum Medyczne Nowa Sol	Nowa Sol	Lubuskie
Poland	Klinika Reumatologii i Rehabilitacji	Poznan
Poland	Klinika Reumatologii, Chorob Wewnetrznych i Geriatrii PUM	Szczecin
Poland	Centrum Medyczne AMED	Warszawa
Poland	Medycyna Kliniczna	Warszawa	Mazowieckie
Poland	Reumatika - Centrum Reumatologii	Warszawa	Mazowieckie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.	Wroclaw	Dolnoslaskie
Romania	C.M.D.T.A. Neomed	Brasov	Bra?ov
Romania	SANA Medical Center	Bucharest
Romania	Spitalul Clinic "Dr. Ioan Cantacuzino"	Bucuresti
Romania	Spitalul Clinic Sf Maria Bucuresti	Bucuresti
Romania	Spitalul Euroclinic	Bucureti	Bucure?ti
Romania	Craiova Emergency Clinical County Hospital	Craiova	Dolj
Romania	Napoca Emergency Clinical County Hospital	Napoca	Cluj
Russian Federation	Chelyabinsk Regional Clinical Hospital	Chelyabinsk
Russian Federation	City Hospital # 7	Kazan
Russian Federation	City Clinical Hospital 1 named after N.I. Pirogov	Moscow
Russian Federation	Moscow City Clinical Hospital Number 52	Moscow	Moskva
Russian Federation	Russian National Research Medical University n.a. N.I.Pirogov	Moscow
Russian Federation	V.A. Nasonova Research Institute of Rheumatology	Moscow
Russian Federation	Institute of Cytology and Genetics of Siberian Branch of Russian Academy of Medical Sciences	Novosibirsk
Russian Federation	Research Institute of Clinical Immunology	Novosibirsk
Russian Federation	Regional Hospital - Omsk	Omsk
Russian Federation	Orenburg State Medical Academy of Roszdrav	Orenburg
Russian Federation	Kursk Regional Clinical Hospital	Rursk
Russian Federation	Ryazan State Medical University	Ryazan
Russian Federation	Russian Medical Military Academy n.a. S.M. Kirov	Saint Petersburg
Russian Federation	Departmental Hospital at Smolensk Station "rzhd" JSC	Smolensk
Russian Federation	LLC MK Med	St. Petersburg	Saint Petersburg
Russian Federation	Kuvatov Republican Clinical Hospital	Ufa
Russian Federation	LLC Medical Center Zdorovaya Semiya	Zonova
Serbia	Institute of Rheumatology	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	University Clinical Center of Serbia	Belgrade
Serbia	Institute for Treatment and Rehabilitation Niska Banja	Niska Banja
Serbia	Clinical Center of Vojvodina	Novi Sad
South Africa	Panorama Medical Centre	Cape Town	Western Cape
South Africa	Vincent Pallotti Hospital	Cape Town	Western Cape
South Africa	WITS Clinical Research	Johannesburg	Gauteng
South Africa	Jakaranda Hospital	Pretoria	Gauteng
South Africa	University Of Pretoria	Pretoria
South Africa	Winelands Medical Research Centre	Stellenbosch	Western Cape
South Africa	Suite 509 Umhlanga Netcare Medical Centre	Umhlanga	Durban
Spain	Corporació Sanitària Clínic	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital De Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Marina Baixa	La Vila Joiosa	Alicante
Spain	Corporacion Sanitaria Parc Tauli	Sabadell	Barcelona
Spain	Hospital Quiron Infanta Luisa	Sevilla
Spain	Hospital do Meixoeiro	Vigo	Pontevedra
Switzerland	Cantonal Hospital St.Gallen	st.Gallen	Sankt Gallen
Taiwan	Hualien Tzu-Chi Hospital	Dalin Township
Taiwan	Chang Gung Memorial Hospital - Kaohsiung Branch	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chi-Mei Medical Center	Tainan City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital - Linkou	Taoyuan City
United Kingdom	Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust	Doncaster
United Kingdom	Leeds Teaching Hospital	Leeds
United Kingdom	Whipps Cross University Hospital	Leytonstone	London
United Kingdom	Guys/St. Thomas Hospital	London	Surrey
United Kingdom	Maidstone Hospital	Maidstone	Kent
United Kingdom	St George's Hospital	Tooting	London
United States	Amarillo Center for Clinical Research	Amarillo	Texas
United States	Arthritis Clinic of Northern VA, P.C.	Arlington	Virginia
United States	Emory University	Atlanta	Georgia
United States	Piedmont Healthcare	Atlanta	Georgia
United States	Arthritis and Rheumatic Disease	Aventura	Florida
United States	Johns Hopkins Asthma and Allergy Center	Baltimore	Maryland
United States	Accurate Clinical Management	Baytown	Texas
United States	East Penn Rheumatology Associates	Bethlehem	Pennsylvania
United States	Wallace Rheumatic Studies Center	Beverly Hills	California
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	New England Research Associates	Bridgeport	Connecticut
United States	St. Lawrence Health System	Canton	New York
United States	Box Arthritis & Rheumatology of the Carolinas, PLLC	Charlotte	North Carolina
United States	Joint and Muscle Medical Care	Charlotte	North Carolina
United States	Cincinnati Rheumatic Disease Study Group	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	Dr. Dhiman Basu Private Practice	Colleyville	Texas
United States	Medvin Clinical Research - Weidmann	Covina	California
United States	Eagle Medical	Crossville	Tennessee
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Spectrum Medical Inc.	Danville	Virginia
United States	Denver Arthritis Clinic - Lowry	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Precision Comprehensive Clinical Research Solutions	Fort Worth	Texas
United States	Providence Medical Foundation	Fullerton	California
United States	Rheumatic Disease Center	Glendale	Wisconsin
United States	Medication Management	Greensboro	North Carolina
United States	MD Medical Corporation	Hemet	California
United States	Accurate Clinical Research	Houston	Texas
United States	Rheumatology Center Of Houston	Houston	Texas
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Glacir View Research Institute	Kalispell	Montana
United States	Advanced Rheumatology, PC	Lansing	Michigan
United States	Arthritis and Osteoporosis Associates of New Mexico	Las Cruces	New Mexico
United States	North Georgia Rheumatology, PC	Lawrenceville	Georgia
United States	Arthritis Center of Lexington	Lexington	Kentucky
United States	The Feinstein Institute for Medical Research	Manhasset	New York
United States	Southwest Rheumatology, P.A.	Mesquite	Texas
United States	Lakes Research, LLC	Miami Lakes	Florida
United States	Paramount Medical Research	Middleburg Heights	Ohio
United States	Columbia University Medical Center	New York	New York
United States	NYU Langone	New York	New York
United States	Arthritis & Rheumatology Center of Oklahoma PLLC	Oklahoma City	Oklahoma
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Millennium Research	Ormond Beach	Florida
United States	Arizona Arthritis & Rheumatology Research	Phoenix	Arizona
United States	Integral Rheumatology & Immunology Specialists	Plantation	Florida
United States	IRIS Research and Development, LLC	Plantation	Florida
United States	ACRC Studies	Poway	California
United States	Allied Clinical Research	Reno	Nevada
United States	Clinical Research Institute of Michigan, LLC	Saint Clair Shores	Michigan
United States	Accurate Clinical Research, Inc.	San Antonio	Texas
United States	Articularis Healthcare d/b/a/ Low Country Rheumatology, PA	Summerville	South Carolina
United States	SUNY Upstate Medical University	Syracuse	New York
United States	ForCare Clinical Research	Tampa	Florida
United States	Tampa Medical Group, P.A.	Tampa	Florida
United States	Advanced Rheumatology of Houston	The Woodlands	Texas
United States	Arizona Arthritis & Rheumatology Associates, P. C.	Tucson	Arizona
United States	Inland Rheumatology & Osteoporosis Medical Group	Upland	California
United States	Medvin Clinical Research - Weidmann	Whittier	California
United States	Clinical Research Center of Reading,LLC	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Incyte Corporation

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Chile,  China,  Colombia,  Croatia,  Czechia,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Philippines,  Poland,  Romania,  Russian Federation,  Serbia,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	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
Primary	Percentage of Participants With Adverse Events of Special Interest (AESIs)	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
Primary	Percentage of Participants With Serious Adverse Events (SAEs)	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
Primary	Percentage of Participants With Temporary Investigational Product Interruptions	Percentage of participants with temporary investigational product interruptions.	Week 134
Primary	Percentage of Participants With Permanent Investigational Product Discontinuations	Percentage of participants with permanent investigational product discontinuations.	Week 134
Secondary	Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response	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
Secondary	Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)	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
Secondary	Change From Baseline in Prednisone Dose	Change from baseline in prednisone dose.	Baseline through Week 48
Secondary	Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate	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
Secondary	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	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
Secondary	Change From Baseline in Tender Joint Count	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
Secondary	Change From Baseline in Swollen Joint Count	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
Secondary	Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score	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
Secondary	Change From Baseline in Worst Pain Numeric Rating Scale (NRS)	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

External Links

•   A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)