Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— SELECT-SLE  

Official title:

SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843643
• Other study ID #: M23-699
• Secondary ID: 2023-503655-10-0
• Status: Recruiting
• Phase: Phase 3
• Start date: July 19, 2023
• Est. completion date: October 31, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed.

Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 3 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib based on their disease activity and their original treatment assignment in Study 1 or 2. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world.

Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2027
• Est. primary completion date: October 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 63 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.

• At Screening, must have at least one of the following:

• antinuclear antibody (ANA) positive (titer >= 1:80)

• anti-double stranded deoxyribonucleic acid (dsDNA) positive

• anti-Smith positive

• Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) >= 6, of which >= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as >= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.

• Physician's Global Assessment (PhGA) >= 1 during screening period.

• On stable background treatment for >= 60 days prior to Baseline (with the exception of oral corticosteroid [OCS], which must be at a stable dose for >=14 days prior to Baseline) with

• antimalarial(s) [hydroxychloroquine <= 400 mg daily, chloroquine <= 500 mg daily, quinacrine <= 100 mg daily];

• and/or prednisone (or prednisone-equivalent) (<= 20 mg daily);

• and/or no more than 1 of the following: azathioprine (<= 150 mg daily), 6-mercaptopurine (<= 150 mg daily), mycophenolate mofetil (<= 2 g daily), mycophenolate sodium <= 1,440 mg/day, leflunomide (<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (<= 23.7 mg twice daily), methotrexate (<= 25 mg weekly), or mizoribine (<= 150 mg daily).

Exclusion Criteria:

• Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.

• Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.

• SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).

• Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.

• Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.

• History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.

• Pregnancy, breastfeeding, or considering becoming pregnant during the study.

• Clinically relevant or significant ECG abnormalities at Screening.

• Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Upadacitinib
Oral Tablets
• Placebo
Oral Tablet

Locations

Country	Name	City	State
Australia	Emeritus Research Sydney /ID# 256249	Botany	New South Wales
Australia	Emeritus Research /ID# 256800	Camberwell	Victoria
Australia	Monash Medical Centre /ID# 255678	Clayton	Victoria
Australia	Concord Repatriation General Hospital /ID# 257945	Concord	New South Wales
Australia	Holdsworth House Medical Practice /ID# 253542	Darlinghurst	New South Wales
Australia	Colin Bayliss Research and Teaching Unit /ID# 261077	Victoria Park	Western Australia
Belgium	Universite Libre de Bruxelles - Hopital Erasme /ID# 261997	Anderlecht	Bruxelles-Capitale
Bosnia and Herzegovina	Klinicki centar Banja Luka /ID# 253581	Banja Luka
Bosnia and Herzegovina	Klinicki centar Banja Luka /ID# 253582	Banja Luka
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 253583	Sarajevo
Bosnia and Herzegovina	Polyclinic Srce Sarajeva /ID# 255475	Sarajevo
Brazil	EDUMED Educacao em Saude S/S LTDA /ID# 253274	Curitiba	Parana
Brazil	CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 253346	Juiz de Fora	Minas Gerais
Brazil	Hospital de Clinicas de Porto Alegre /ID# 253357	Porto Alegre	Rio Grande Do Sul
Brazil	LMK Sevicos Medicos S/S /ID# 253353	Porto Alegre	Rio Grande Do Sul
Brazil	SER - Servicos Especializados em Reumatologia da Bahia /ID# 253354	Salvador	Bahia
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 261024	Sao Jose Do Rio Preto	Sao Paulo
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 254316	Sao Paulo
Brazil	Hospital do Rim /ID# 253983	Sao Paulo
Brazil	CEDOES - Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo /ID# 254588	Vitoria	Espirito Santo
Bulgaria	Medical Center Artmed Ltd /Id# 254572	Plovdiv
Bulgaria	Medical center Unimed /ID# 253324	Plovdiv
Bulgaria	UMHAT Kaspela EOOD /ID# 252645	Plovdiv
Bulgaria	Medical center Teodora /ID# 252646	Ruse
Bulgaria	Military Medical Academy Multiprofile Hospital /ID# 252644	Sofia
Bulgaria	Diagnostic consultative center Focus-5 /ID# 252642	Sofiya
Bulgaria	Diagnostic consultative center Focus-5 /ID# 252643	Sofiya
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 254841	Concepción
Chile	Inmunocel /Id# 256390	Las Condes	Region Metropolitana De Santiago
Chile	Investigaciones Medicas Limitada /Id# 254842	Providencia
Chile	Centro Internacional de Estudios Clinicos - CIEC /ID# 254838	Santiago
Chile	Servicio de Salud Araucanía Norte Hospital Victoria /ID# 255179	Victoria	Araucania
China	China-Japan Friendship Hospital /ID# 253048	Beijing	Beijing
China	Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 253045	Beijing	Beijing
China	Peking University Third Hospital /ID# 253138	Beijing	Beijing
China	The first affiliated hospital of bengbu medical college /ID# 252853	Bengbu	Anhui
China	The First Hospital of Jilin University /ID# 252771	Changchun	Jilin
China	The First People's Hospital of Changzhou /ID# 252992	Changzhou	Jiangsu
China	West China Hospital, Sichuan University /ID# 252854	Chengdu	Sichuan
China	Guangdong Provincial People's Hospital /ID# 252920	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 253137	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University /ID# 252927	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University /ID# 252921	Guangzhou	Guangdong
China	The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252923	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 252633	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital /ID# 253860	Hangzhou	Zhejiang
China	The Affiliated Hospital of Inner Mongolia Medical University /ID# 252629	Huhehaote	Inner Mongolia
China	Jining No.1 People's Hospital /ID# 252897	Jining	Shandong
China	The First People's Hospital of Jiujiang /ID# 252989	Jiujiang	Jiangxi
China	First Affiliated Hospital of Kunming Medical University /ID# 252925	Kunming
China	Linyi People's Hospital /ID# 252898	Linyi	Shandong
China	Jiangxi Provincial People's Hospital /ID# 252940	Nanchang
China	Nanjing Drum Tower Hospital /ID# 253042	Nanjing	Jiangsu
China	Affiliated hospital of nantong university /ID# 252991	Nantong	Jiangsu
China	Jiangxi Pingxiang People's Hospital /ID# 252919	Pingxiang	Jiangxi
China	The First Affiliated Hospital of Shantou University Medical College /ID# 253426	Shantou	Guangdong
China	Tianjin Medical University General Hospital /ID# 252868	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University /ID# 253649	Wenzhou	Zhejiang
China	Tongji Hospital Tongji Medical College of HUST /ID# 252632	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 252963	Wuhan	Hubei
China	Wuxi People's Hospital /ID# 253858	Wuxi	Jiangsu
China	Second Affiliated Hospital of Xian Jiaotong University /ID# 252861	Xi'an	Shaanxi
China	Xuzhou Central Hospital /ID# 252922	Xuzhou	Jiangsu
China	Yancheng First People's Hospital /ID# 254599	Yancheng	Jiangsu
China	Northern Jiangsu People's Hospital /ID# 252945	Yangzhou
China	Zhuzhou Central Hospital /ID# 252962	Zhuzhou	Hunan
Colombia	Clinica de la Costa S.A.S /ID# 260727	Barranquilla
Colombia	Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 254097	Bogotá	Cundinamarca
Colombia	Fundacion Oftalmologica de Santander - FOSCAL /ID# 254100	Bucaramanga	Santander
Colombia	Hospital Pablo Tobón Uribe /ID# 254101	Medellín
Colombia	Healthy Medical Center S.A.S /ID# 254098	Zipaquirá	Cundinamarca
Croatia	Poliklinika Solmed /ID# 252965	Grad Zagreb
Croatia	Klinicki bolnicki centar Osijek /ID# 252847	Osijek
Croatia	Klinicki bolnicki centar Rijeka /ID# 252848	Rijeka	Primorsko-goranska Zupanija
Croatia	Klinicki Bolnicki Centar (KBC) Split /ID# 252849	Split	Splitsko-dalmatinska Zupanija
Croatia	Poliklinika Bonifarm /ID# 252846	Zagreb
Estonia	East Tallinn Central Hospital - Magdaleena Unit /ID# 253721	Tallinn	Harjumaa
Estonia	Innomedica /ID# 253722	Tallinn
Estonia	North Estonia Medical Centre Foundation /ID# 253723	Tallinn
Estonia	MediTrials /ID# 253720	Tartu
France	HCL - Hopital de la Croix-Rousse /ID# 254147	Lyon	Rhone
France	Hopital Pitie Salpetriere /ID# 253009	Paris
France	CHU Toulouse - Hopital Rangueil /ID# 254148	Toulouse	Haute-Garonne
Germany	Immanuel Krankenhaus Berlin /ID# 253389	Berlin-buch
Germany	Krankenhaus Porz am Rhein /ID# 254373	Cologne
Germany	Fraunhofer Institute for Translational Medicine & Pharmacology ITMP /ID# 253734	Frankfurt am Main
Greece	General Hospital of Athens Laiko /ID# 252952	Athens	Attiki
Greece	University General Hospital Attikon /ID# 253209	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 252951	Heraklion	Kriti
Guatemala	Clinica Especializada en Medicina Interna /ID# 255006	Guatemala
Guatemala	Clínica Médica Especializada en Medicina Interna y Reumatologia /ID# 257248	Guatemala
Guatemala	Clinica Medica Especializada en Medicina Interna y Reumatologia /ID# 261156	Guatemala
Guatemala	Clinica Medica Reumatologica /ID# 255009	Guatemala
Hungary	Debreceni Egyetem-Klinikai Kozpont /ID# 252877	Debrecen	Hajdu-Bihar
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 254552	Pecs
Hungary	Vital Medicina Kft /ID# 252876	Veszprém	Veszprem
Israel	The Lady Davis Carmel Medical Center /ID# 253303	Haifa	H_efa
Israel	Hadassah Medical Center-Hebrew University /ID# 252654	Jerusalem	Yerushalayim
Israel	Meir Medical Center /ID# 254187	Kfar Saba	HaMerkaz
Israel	Galilee Medical Center /ID# 252859	Nahariya	HaTsafon
Israel	The Chaim Sheba Medical Center /ID# 252857	Ramat Gan	Tel-Aviv
Israel	Tel Aviv Sourasky Medical Center /ID# 252858	Tel Aviv	Tel-Aviv
Italy	Azienda Ospedaliero Universitaria Pisana /ID# 254289	Pisa
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 253680	Rome	Roma
Italy	Sapienza University /ID# 254288	Rome	Roma
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 254138	Torette	Ancona
Japan	Tokyo Medical And Dental University Hospital /ID# 254430	Bunkyo-ku	Tokyo
Japan	National Hospital Organization Chibahigashi National Hospital /ID# 253268	Chiba-shi	Chiba
Japan	University of Yamanashi Hospital /ID# 253264	Chuo-shi	Yamanashi
Japan	Saitama Medical Center /ID# 253263	Kawagoe-shi	Saitama
Japan	Hospital of the University of Occupational and Environmental Health, Japan /ID# 253269	Kitakyushu-shi	Fukuoka
Japan	University of Miyazaki Hospital /ID# 253416	Miyazaki-shi	Miyazaki
Japan	Shinkenko Clinic /ID# 253271	Naha-shi	Okinawa
Japan	Okayama University Hospital /ID# 253821	Okayama
Japan	Hokkaido University Hospital /ID# 253306	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital /ID# 253267	Sendai-shi	Miyagi
Korea, Republic of	SoonChunHyang University Hospital Cheonan /ID# 254777	Cheonan-si	Chungcheongnamdo
Korea, Republic of	Chonnam National University Bitgoeul Hospital /ID# 254675	Gwangju	Gwangju Gwang Yeogsi
Korea, Republic of	Asan Medical Center /ID# 254022	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Hanyang University Seoul Hospital /ID# 252955	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, Seoul St. Marys Hospital /ID# 252958	Seoul	Seoul Teugbyeolsi
Latvia	M & M Centrs LTD /ID# 253752	Adazi
Latvia	Daugavpils Regional Hospital /ID# 253754	Daugavpils
Latvia	Pauls Stradins Clinical University Hospital /ID# 253750	Riga	Riga
Latvia	Riga East Clinical University Hospital /ID# 253751	Riga	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 253755	Kaunas
Lithuania	Republic Klaipeda Hospital /ID# 253759	Klaipeda
Lithuania	Inlita Santara CTC /ID# 253758	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos /ID# 253756	Vilnius
New Zealand	Aotearoa Clinical Trials /ID# 253555	Papatoetoe	Auckland
New Zealand	North Shore Hospital /ID# 253554	Takapuna	Auckland
Poland	MICS Centrum Medyczne Bydgoszcz /ID# 253281	Bydgoszcz	Kujawsko-pomorskie
Poland	Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 253233	Bydgoszcz	Kujawsko-pomorskie
Poland	ETYKA-Osrodek Badan Klinicznych /ID# 252967	Olsztyn	Warminsko-mazurskie
Poland	Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 252964	Poznan	Wielkopolskie
Poland	MICS Centrum Medyczne Warszawa /ID# 253273	Warsaw	Mazowieckie
Portugal	Hospital Garcia de Orta /ID# 252903	Almada	Setubal
Portugal	Centro Hospitalar do Tamega e Sousa - Hospital Padre Americo /ID# 252911	Guilhufe	Porto
Portugal	Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252902	Ponte de Lima	Viana Do Castelo
Portugal	Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 252899	Porto
Puerto Rico	Clinical Research Investigator Group, LLC /ID# 259170	Bayamon
Puerto Rico	Caribbean Medical Research Center /ID# 254882	San Juan
Puerto Rico	Clinical Research Puerto Rico /ID# 256352	San Juan
Puerto Rico	GCM Medical Group PSC /ID# 253039	San Juan
Puerto Rico	Mindful Medical Research /ID# 253040	San Juan
Romania	Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 253207	Brasov
Romania	Spitalul Clinic Sf. Maria /ID# 252905	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 252904	Cluj-Napoca	Cluj
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 253179	Belgrade	Beograd
Serbia	Institute for Rheumatology /ID# 253172	Belgrade	Beograd
Serbia	Institute for Rheumatology /ID# 253173	Belgrade	Beograd
Serbia	Institute for Rheumatology /ID# 253174	Belgrade	Beograd
Serbia	Institute for Rheumatology /ID# 253175	Belgrade	Beograd
Serbia	University Clinical Center Vojvodina /ID# 253176	Novi Sad
Serbia	General Hospital Djordje Joanovic /ID# 253177	Zrenjanin	Vojvodina
Slovakia	ZAZABIE s. r .o. /ID# 255793	Košice II
Slovakia	ARTROMAC n.o. /ID# 253056	Kosice
Slovakia	MEDMAN s.r.o. /ID# 252950	Martin
South Africa	Arthritis Clinical Research Trials /ID# 253349	Cape Town	Western Cape
South Africa	Winelands Medical Research - Somerset West /ID# 254614	Cape Town	Western Cape
South Africa	Wits Clinical Research /ID# 252931	Johannesburg	Gauteng
South Africa	Dr Elsa van Duuren /ID# 254218	Pretoria	Gauteng
South Africa	University of Pretoria /ID# 252932	Pretoria	Gauteng
South Africa	Winelands Medical Research Centre /ID# 252934	Stellenbosch	Western Cape
South Africa	Dr Asokan Naidoo /ID# 253351	Umhlanga	Kwazulu-Natal
Spain	Complejo Hospitalario Universitario A Coruña /ID# 253123	A Coruña	A Coruna
Spain	Hospital Universitario Virgen de Valme /ID# 253121	Sevilla
Spain	Hospital Meixoeiro (CHUVI) /ID# 253124	Vigo	Pontevedra
Switzerland	Universitätsspital Basel /ID# 252907	Basel Town	Basel-Stadt
Switzerland	Inselspital, Universitaetsspital Bern /ID# 252909	Bern
Switzerland	Kantonsspital St. Gallen /ID# 252906	St. Gallen	Sankt Gallen
Taiwan	Chang Gung Mem Hosp Keelung /ID# 253636	Keelung
Taiwan	China Medical University Hospital /ID# 252936	Taichung
Taiwan	National Taiwan University Hospital /ID# 252937	Taipei City	Taipei
Turkey	Akdeniz Universitesi Tip Fakul /ID# 252839	Antalya
United Kingdom	North West Anglia NHS Foundation Trust /ID# 254590	Bretton	Cambridgeshire
United Kingdom	Western Health and Social Care Trust /ID# 254592	Londonderry
United Kingdom	Luton and Dunstable Hospital NHS Foundation Trust /ID# 255323	Luton
United Kingdom	Northampton General Hospital NHS Trust /ID# 254813	Northampton	Northamptonshire
United Kingdom	Portsmouth Hospitals University NHS Trust /ID# 252986	Portsmouth
United States	Arthritis and Rheumatology Research Institute, PLLC /ID# 253014	Allen	Texas
United States	Arthritis and Rheumatic Disease Specialties /ID# 253624	Aventura	Florida
United States	HARAC Research Corp. /ID# 254922	Avon Park	Florida
United States	David S. Hallegua MD, A Professional Corporation /ID# 253902	Beverly Hills	California
United States	Wallace Rheumatic Studies Center, LLC /ID# 252806	Beverly Hills	California
United States	Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623	Boca Raton	Florida
United States	Bay Area Arthritis and Osteo /ID# 253597	Brandon	Florida
United States	Joseph S. and Diane H. Steinberg Ambulatory Care Center /ID# 253592	Brooklyn	New York
United States	AZ Arthritis and Rheumatology /ID# 261848	Chandler	Arizona
United States	DJL Clinical Research, PLLC /ID# 253620	Charlotte	North Carolina
United States	University of Cincinnati Medical Center /ID# 259174	Cincinnati	Ohio
United States	Believe Clinical Trials /ID# 255427	Coral Springs	Florida
United States	Arthritis Care of Texas /ID# 261719	Corpus Christi	Texas
United States	International Medical Research /ID# 253617	Daytona Beach	Florida
United States	Omega Research Debary, LLC /ID# 254939	DeBary	Florida
United States	Denver Arthritis Clinic /ID# 253189	Denver	Colorado
United States	AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767	Flagstaff	Arizona
United States	Arthiritis and Rheumatology Specialists PA /ID# 255950	Fort Worth	Texas
United States	JPS Rheumatology Clinic /ID# 253185	Fort Worth	Texas
United States	Providence - St. Jude Medical Center /ID# 252822	Fullerton	California
United States	Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820	Gilbert	Arizona
United States	Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824	Glendale	Arizona
United States	AA Medical Research Center - Grand Blanc /ID# 253028	Grand Blanc	Michigan
United States	Neoclinical Research /ID# 253614	Hialeah	Florida
United States	Hinsdale Orthopaedics /ID# 253018	Hinsdale	Illinois
United States	Western KY Rheumatology /ID# 254937	Hopkinsville	Kentucky
United States	Newport Huntington Medical Group /ID# 252827	Huntington Beach	California
United States	West Tennessee Research Institute /ID# 252807	Jackson	Tennessee
United States	Encore Research Group-Jacksonville Center for Clinical Research /ID# 257272	Jacksonville	Florida
United States	UF Health Rheumatology /ID# 255351	Jacksonville	Florida
United States	Logan Health Research /ID# 252808	Kalispell	Montana
United States	Kansas City Physician Partners /ID# 254786	Kansas City	Missouri
United States	R & H Clinical Research - 777 Katy /ID# 254126	Katy	Texas
United States	Trinity Research Centers /ID# 262039	Kennesaw	Georgia
United States	Moores Cancer Center at UC San Diego /ID# 253903	La Jolla	California
United States	Arthritis & Osteo Medical Ctr /ID# 252812	La Palma	California
United States	June DO, PC /ID# 253030	Lansing	Michigan
United States	Arthritis and Osteoporosis Associates of New Mexico /ID# 252818	Las Cruces	New Mexico
United States	Dartmouth-Hitchcock Medical Center /ID# 254923	Lebanon	New Hampshire
United States	Deerbrook Medical Associates /ID# 253029	Libertyville	Illinois
United States	Life Clinical Trials /ID# 253615	Margate	Florida
United States	Atlanta Research Center for Rheumatology /ID# 253610	Marietta	Georgia
United States	Valley Arthritis Center /ID# 253022	McAllen	Texas
United States	Shelby Research /ID# 256937	Memphis	Tennessee
United States	Lakes Research, LLC /ID# 253621	Miami	Florida
United States	Paramount Medical Research and Consulting /ID# 253016	Middleburg Heights	Ohio
United States	Yale University School of Medicine /ID# 254567	New Haven	Connecticut
United States	NYU Langone Orthopedic Center /ID# 253613	New York	New York
United States	Advanced Quality Medical Research /ID# 254983	Orland Park	Illinois
United States	HMD Research LLC /ID# 253595	Orlando	Florida
United States	Millennium Research /ID# 253600	Ormond Beach	Florida
United States	Clinical Research Source, Inc. /ID# 253027	Perrysburg	Ohio
United States	Albert Einstein Medical Center /ID# 256661	Philadelphia	Pennsylvania
United States	Clinical Research of Philadelphia, LLC /ID# 254156	Philadelphia	Pennsylvania
United States	Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831	Phoenix	Arizona
United States	Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825	Phoenix	Arizona
United States	Trinity Universal Research Associates, Inc /ID# 253013	Plano	Texas
United States	IRIS Research and Development, LLC /ID# 253618	Plantation	Florida
United States	St. Lawrence Health System /ID# 253598	Potsdam	New York
United States	Raleigh Medical Group /ID# 256328	Raleigh	North Carolina
United States	Carilion Clinic /ID# 253374	Roanoke	Virginia
United States	OrthoIllinois /ID# 253188	Rockford	Illinois
United States	BayCare Medical Group /ID# 253593	Saint Petersburg	Florida
United States	Accellacare - Salisbury /ID# 253608	Salisbury	North Carolina
United States	Clinical Trials of Texas, Inc /ID# 254949	San Antonio	Texas
United States	Sun Research Institute /ID# 255832	San Antonio	Texas
United States	Providence St. John's Health Center /ID# 253905	Santa Monica	California
United States	Greater Chicago Specialty Physicians /ID# 253021	Schaumburg	Illinois
United States	Willis Knighton /ID# 256343	Shreveport	Louisiana
United States	Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253020	Skokie	Illinois
United States	NorthShore University HealthSystem - Skokie /ID# 254568	Skokie	Illinois
United States	BayCare Medical Group, Inc. /ID# 255135	Tampa	Florida
United States	Clinical Research of West Florida - Tampa /ID# 253602	Tampa	Florida
United States	Clinical Research of West Florida, Inc /ID# 253899	Tampa	Florida
United States	Millennium Clinical Trials /ID# 252817	Thousand Oaks	California
United States	DM Clinical Research - Tomball /ID# 255134	Tomball	Texas
United States	Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828	Tucson	Arizona
United States	Atrium Health Wake Forest Baptist Medical Center /ID# 254125	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Chile,  China,  Colombia,  Croatia,  Estonia,  France,  Germany,  Greece,  Guatemala,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Romania,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response	BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.	At Week 52
Secondary	Percentage of Flares Participants Experiencing Over Time (Number of Flares Per Patient-Year)	Flare is defined by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Systemic lupus erythematosus disease activity index (SLEDAI) Flare Index (SFI). An index defining Systemic lupus erythematosus (SLE) flares using changes in the Hybrid SLEDAI (hSLEDAI) score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity. Flare rate is number of flares per patient-year.	Week 52
Secondary	Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4	SRI is a composite responder index based on improvement in disease activity (number following SRI indicates numerical improvement in hSLEDAI score) without worsening of the overall condition (no worsening in Physician's Global Assessment (PhGA), < 0.3 point increase) or the development of significant disease activity in new organ systems (no new British Isles Lupus Assessment Group [BILAG] A or > 1 new BILAG B).	At Week 52
Secondary	Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)	LLDAS is a state of low disease activity based on SLEDAI score (hSLEDAI score <= 4 excluding hSLEDAI activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA <= 1), and concomitant medication usage.	At Week 52
Secondary	Time to First Flare per SELENA SLEDAI Flare Index (SFI)	SFI is an index defining SLE flares using changes in the hSLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.	Week 52
Secondary	Percentage of Participants Achieving Oral Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent	Achievement of oral glucocorticoid dose <=7.5 mg/day prednisone-equivalent among participants taking >= 10 mg/day prednisone-equivalent at baseline.	From Week 44 to Week 52
Secondary	Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints	Achievement of >= 50% improvement in tender or swollen joints among participants with >= 3 swollen joints and >= 6 total affected joints at Baseline.	Week 52
Secondary	Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score	CLASI index used to assess cutaneous manifestations of SLE summarizing the activity of the disease. Scores range from 0 to 70, with higher scores indicating more severity. Achievement of >= 50% reduction in CLASI activity score among participants with baseline score >=10.	Week 52
Secondary	Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)	The Lupus Pain-NRS is a single-item questionnaire in which participants are asked to rate their overall pain level due to lupus over the last week. The Lupus Pain-NRS scores range from 0 to 10, with higher scores indicating a higher level of pain.	Baseline to Week 52
Secondary	Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4	The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue.	Baseline to Week 52
Secondary	Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS)	The SF-36v2® Health Survey Acute is a general HRQoL instrument with extensive use in multiple disease states. The instrument comprises 36 total items (questions) targeting a participants's functional health and well-being in 8 dimensions (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Scoring is totaled into a Physical Component Summary and a Mental Component Summary. Higher scores indicate a better state of health.	Baseline to Week 52

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