Clinical trial NCT04058028: Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
Official title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus (SLE)
Keywords: Standard of Care therapies
Oral Corticosteroids
Inmunosuppressants
Immunomodulators
Systemic Lupus Erythematosus
B cell Activating Factor (BAFF)
Inducible T cell costimulator ligand (ICOSL)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-08-15
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including OCS, immunosuppressants, and immunomodulators. Subjects will be randomized to receive placebo or 1 of 3 doses of Rozibafusp Alfa with the last dose at week 50. Treatment will be administered every 2 weeks (Q2W). All subjects will be required to complete a 16-week follow-up period after the 52-week treatment period.

The first interim analysis (IA) will be executed after the first 40 enrolled subjects have had the opportunity to complete the week 24 assessment. Additional IAs may be executed after approximately every 32 newly enrolled subjects have had the opportunity to complete the week 24 assessment. The last IA will occur when all subjects have had the opportunity to complete the week 24 assessment.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

Detailed description: This is a Bayesian adaptive phase 2b, multi-center, double-blind, randomized, placebo-controlled, 52-week, dose-ranging study in subjects with active SLE and inadequate response to SOC therapies including oral corticosteroids (OCS), immunosuppressants and immunomodulators. Previous biologic use is allowed with an adequate washout period.

Eligibility criteria: Inclusion Criteria Screening Visit:

* Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
* Age ≥ 18 years to ≤ 75 years at screening visit.
* Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody ≥ 1:80 by immunofluorescence on Hep-2 cells being present at screening.
* Hybrid SLEDAI score ≥ 6 points with a "Clinical" hSLEDAI score ≥ 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.
* Additional protocol-specific rules are applied at screening and throughout the study, as follows:

  * Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring.
  * Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia ≥ 2.
  * Oral ulcers: Ulcers location and appearance must be documented by the investigator.
  * Scleritis and Episcleritis: the presence of stable SLE-related scleritis and episcleritis must be documented by an ophthalmologist and other causes excluded.
  * Renal: subjects with urine protein/creatinine ratio \< 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI ≥ 4 and did not receive induction treatment for nephritis within the last year.
  * Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI.
* Unless there is a documented intolerance, subjects must be taking:

  * Only 1 of the following SLE treatments: anti-malarial (hydroxychloroquine, chloroquine, or quinacrine), azathioprine, methotrexate, leflunomide, mycophenolate mofetil/acid mycophenolic, or dapsone.

OR

• 2 of the above-mentioned SLE treatments in which 1 must be anti-malarial (hydroxychloroquine, chloroquine, or quinacrine).

* Treatment should be taken for ≥ 12 weeks prior to screening and must be a stable dose for ≥ 8 weeks prior to screening.
* For subjects taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit for ≥ 2 weeks prior to screening visit.

Exclusion Criteria Screening Visit

Subjects are excluded from the study if any of the following criteria apply:

Disease Related

* Urine protein creatinine ratio ≥ 3000 mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit.
* Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.

Primary outcomes:
measure: Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Number of Participants With a SRI-4 Response at Week 24
timeFrame: Week 24
measure: Number of Participants Who Achieved a BILAG Based Combined Lupus Assessment (BICLA) Response at Week 24
timeFrame: Week 24
measure: Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52
timeFrame: Week 52
measure: Number of Participants Who Achieved a BICLA Response at Week 52
timeFrame: Week 52
measure: Number of Participants Achieving a SRI-4 Response With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 In Participants With a Baseline OCS Dose ≥ 10 mg/Day
timeFrame: Up to Week 52
measure: Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI)
timeFrame: Up to Week 52
measure: Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI
timeFrame: Up to Week 52
measure: Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of "Worse" or "New" Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ
timeFrame: Up to Week 52
measure: Number of Participants With ≥6 Tender and Swollen Joints in Hands and Wrists at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52
timeFrame: Week 12, 24, 36, and 52
measure: Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥8 at Baseline Achieving ≥50% Improvement From Baseline at Weeks 12, 24, 36, and 52
timeFrame: Week 12, 24, 36, and 52
measure: Change From Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7a) Score at Weeks 12, 24, 36, 44, and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the Short Form 36 Version 2 (SF-36v2) Health Survey Physical Component Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the SF-36v2 Health Survey Mental Component Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the SF-36v2 Health Survey Physical Functioning Domain Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the SF-36v2 Health Survey Physical Role Domain Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the SF-36v2 Health Survey Bodily Pain Domain Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the SF-36v2 Health Survey General Health Domain Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the SF-36v2 Health Survey Vitality Domain Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the SF-36v2 Health Survey Social Role Functioning Domain Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the SF-36v2 Health Survey Emotional Role Domain Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in the SF-36v2 Health Survey Mental Health Domain Score at Weeks 12, 24, 36, 44 and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in Lupus Quality of Life Questionnaire (LupusQoL) Score at Weeks 12, 24, 36, 44, and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Change From Baseline in Patient Global Assessment Score (PtGA) at Weeks 12, 24, 36, 44, and 52
timeFrame: Week 12, 24, 36, 44, and 52
measure: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 68 weeks
measure: Serum Concentration of Rozibafusp Alfa
timeFrame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 36, Week 44, Week 52, Week 56, Week 60, Week 64, and Week 68
measure: Terminal Half-life of Rozibafusp Alfa
timeFrame: Up to Week 68
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Imaging Endpoints
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Fontana
country: United States
facility: Southern California Permanente Medical Group
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University Hospitals and Clinics
state: California
city: San Diego
country: United States
facility: TriWest Research Associates
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology Immunology and Arthritis
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research LLC
state: Florida
city: Orlando
country: United States
facility: Heuer Medical Doctor Research LLC
state: Florida
city: Tampa
country: United States
facility: Southwest Florida Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: AdventHealth Medical Group
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Skokie
country: United States
facility: Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine Division of Rheumatology
state: Maryland
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: New York University Langone Orthopedic Center
state: New York
city: New York
country: United States
facility: Hospital For Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research PLLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Arthritis and Rheumatology Center of Oklahoma PLLC
state: Oklahoma
city: Tulsa
country: United States
facility: The Oklahoma Center for Arthritis Therapy and Research Inc
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Milton South Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Summerville
country: United States
facility: Articularis Healthcare Group Inc dba Low Country Rheumatology
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic Specialty Research
state: Texas
city: Carrollton
country: United States
facility: Trinity Universal Research Associates, Inc
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clinical Research Center LLC
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology
state: Texas
city: Caba
country: Argentina
facility: Dom Centro de Reumatologia
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion Respirar - Centro Medico Dra De Salvo
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Instituto Medico de Alta Complejidad San Isidro
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Militar Central - Cirujano Mayor Dr Cosme Argerich
state: Distrito Federal
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Clinical Mayo - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L
state: Tucuman
city: San Juan
country: Argentina
facility: CER San Juan - Centro Polivalente de Asistencia e Investigacion Clinica
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Trimontium OOD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment - Kaspela EOOD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD
city: Sofia
country: Bulgaria
facility: Medical Center Academy EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: Medical Centre Synexus Sofia EOOD
city: Stara Zagora
country: Bulgaria
facility: Medical Centre Synexus Sofia EOOD - Branch Stara Zagora
city: Calgary
country: Canada
facility: University of Calgary Cumming School of Medicine
state: Alberta
city: Winnipeg
country: Canada
facility: Shared Health Inc. operating the Health Sciences Centre Winnipeg
state: Manitoba
city: Quebec
country: Canada
facility: Groupe de recherche en maladies osseuses Incorporated
city: Praha 2
country: Czechia
facility: Synexus Czech sro
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
city: Caen Cedex 9
country: France
facility: CHU Hôpital Côte de Nacre
city: Dijon Cedex
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hopital Francois Mitterrand
city: Lille cedex 01
country: France
facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Reims Cedex
country: France
facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
city: Bad Kreuznach
country: Germany
facility: Johannes Gutenberg Universitaet Mainz
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
city: Athens
country: Greece
facility: Laiko General Hospital
city: Athens
country: Greece
facility: Attiko Hospital
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Patra
country: Greece
facility: General University Hospital of Patras Panagia i Voithia
city: New Territories
country: Hong Kong
facility: Tuen Mun Hospital
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Szekesfehervar
country: Hungary
facility: Vita Verum Medical Bt
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Rozzano MI
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Chiba-shi
country: Japan
facility: National Hospital Organization Chibahigashi National Hospital
state: Chiba
city: Urayasu-shi
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health Japan
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu
city: Sapporo-shi
country: Japan
facility: Sapporo City General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Sendai-shi
country: Japan
facility: National University Corporation Tohoku University Tohoku University Hospital
state: Miyagi
city: Matsumoto-shi
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Omura-shi
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Sasebo-shi
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Kurashiki-shi
country: Japan
facility: Kurashiki Medical Clinic
state: Okayama
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Hamamatsu-shi
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: St Lukes International Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Mexicali
country: Mexico
facility: Centro Medico del Angel SC
state: Baja California Norte
city: Mexicalli
country: Mexico
facility: Centro de Investigacion en Artritis y Osteoporosis SC
state: Baja California Norte
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion SC
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia SA de CV
state: Jalisco
city: Merida
country: Mexico
facility: Centro Peninsular de Investigación Clínica
state: Yucatán
city: Ciudad de Mexico
country: Mexico
facility: Centro Mexicano de Desarrollo de Estudios Clinicos
city: Gdansk
country: Poland
facility: Synexus Polska Spzoo
city: Gdynia
country: Poland
facility: Synexus Polska Spzoo
city: Katowice
country: Poland
facility: Synexus Polska Spzoo
city: Katowice
country: Poland
facility: Silmedic Spzoo
city: Krakow
country: Poland
facility: Tomed Tomasz Miszalski-Jamka Centrum Medyczne
city: Lodz
country: Poland
facility: Synexus Polska Spzoo
city: Lodz
country: Poland
facility: Somed cr
city: Lublin
country: Poland
facility: 1 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Lublin
country: Poland
facility: Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa
city: Poznan
country: Poland
facility: Synexus Polska Spzoo
city: Stalowa Wola
country: Poland
facility: Sanus Szpital Specjalistyczny Spzoo
city: Warszawa
country: Poland
facility: SOMED CR
city: Warszawa
country: Poland
facility: Synexus Polska Spolka z ograniczona odpowiedzialnoscia
city: Wroclaw
country: Poland
facility: Futuremeds spolka z ograniczona odpowiedzialnoscia
city: Wroclaw
country: Poland
facility: Synexus Polska Spzoo
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto EPE - Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Centro Hospitalar Universtario de Sao Joao, EPE
city: Ekaterinburg
country: Russian Federation
facility: State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1
city: Kazan
country: Russian Federation
facility: Limited liability company Scientific Research Medical Complex Your Health
city: Kemerovo
country: Russian Federation
facility: LLC Medical Center Maksimum Zdorovia
city: Kemerovo
country: Russian Federation
facility: LLC Medical center Revma Med
city: Moscow
country: Russian Federation
facility: FSBSI SRI of Rheumatology na V A Nasonova
city: Novosibirsk
country: Russian Federation
facility: LLC Center of medicine Healthy family
city: Novosibirsk
country: Russian Federation
facility: LLC Center of general medicine
city: Saint Petersburg
country: Russian Federation
facility: LLC Medical Sanitary Unit №157
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
state: Galicia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.