Clinical trial NCT04115839: Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2019-10-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who have an inadequate response or are intolerant to biologic disease-modifying anti-rheumatic drugs (DMARD) therapy.


Eligibility criteria: Key Inclusion Criteria:

* Male or female participants who are 18-75 years of age (19-75 years of age at sites in Republic of Korea, 20-75 years of age at sites in Japan and Taiwan), on the day of signing initial informed consent
* Meet Classification Criteria for Psoriatic Arthritis (CASPAR)
* Have a history consistent with Psoriatic Arthritis (PsA) ≥ 6 months at Screening
* Have active PsA defined as ≥ 3 swollen joints (from a 66 swollen joint count \[SJC\]) and ≥ 3 tender joints (from a 68 tender joint count \[TJC\]) at Screening and Day 1; these may or may not be the same joints at Screening and Day 1
* Must have a documented history or active signs of at least one of the following at Screening

  * Plaque psoriasis
  * Nail changes attributed to psoriasis
* Have had inadequate response (lack of efficacy after ≥ 12 week duration of therapy) or intolerance to at least one and not more than 3 biologic DMARDs (bioDMARD) administered for the treatment of PsA or psoriasis, as per local guidelines / standard of care
* Prior to the first dose of study drug on Day 1, treatment with bioDMARD(s) should have been discontinued

Key Exclusion Criteria:

* Prior exposure to a janus kinase (JAK) inhibitor \> 2 doses
* Any active / recent infection
* Any chronic and / or uncontrolled medical condition that would put the individual at increased risk during study participation or circumstances which may make a individual unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement
* Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of investigator

NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA

* Any history of an inflammatory arthropathy with onset before age of 16 years old
* Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the individual by participating in the study, (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator
* Pregnancy or nursing females
* Active drug or alcohol abuse, as per judgement of investigator

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

Primary outcomes:
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
measure: Change From Baseline in PASDAS at Week 48
timeFrame: Baseline, Week 48
measure: Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48
timeFrame: Weeks 20, 24, 28, 36, and 48
measure: Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48
timeFrame: Weeks 20, 24, 28, 36, and 48
measure: Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
measure: Change From Baseline in Physician's Global Assessment of Psoriasis (PhGAP) at Weeks 2, 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the Body Surface Area (BSA) at Baseline
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in PhGAP at Weeks 18, 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Baseline, 18, 20, 24, 28, 36, and 48 weeks
measure: Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Weeks 4, 8, 12, and 16 in Participants With Psoriatic Nail Involvement at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline
timeFrame: Baseline, 20, 24, 28, 36, and 48 weeks
measure: Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline
timeFrame: Baseline, 20, 24, 28, 36, and 48 weeks
measure: Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
measure: Change From Baseline in PsAID-12 Score at Week 48
timeFrame: Baseline, Week 48
measure: Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16
timeFrame: Weeks 4 and 16
measure: Percentage of Participants With PASDAS LDA at Week 48
timeFrame: Week 48
measure: Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16
timeFrame: Weeks 4 and 16
measure: Percentage of Participants Who Achieved PASDAS Remission at Week 48
timeFrame: Week 48
measure: Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Weeks 18, 20, 24, 28, 36, 48, and 60
measure: Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Weeks 18, 20, 24, 28, 36, 48, and 60
measure: Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Weeks 18, 20, 24, 28, 36, 48, and 60
measure: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
measure: Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
measure: Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
measure: Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
measure: Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Individual ACR Component: Health Assessment Questionnaire Disability Index (HAQ-DI)'s Pain Assessment at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
measure: Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
measure: Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60
timeFrame: Baseline, 18, 20, 24, 28, 36, 48 and 60 weeks
measure: Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Weeks 18, 20, 24, 28, 36, 48, and 60
measure: Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Weeks 18, 20, 24, 28, 36, 48, and 60
measure: Time to Achieve DAS28(CRP) LDA
timeFrame: Approximately 16 weeks
measure: Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Weeks 18, 20, 24, 28, 36, 48, and 60
measure: Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Weeks 18, 20, 24, 28, 36, 48, and 60
measure: Time to Achieve DAPSA LDA
timeFrame: Approximately 16 weeks
measure: Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Weeks 18, 20, 24, 28, 36, 48, and 60
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Baseline, 20, 24, 28, 36, and 48 weeks
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 50% Improvement (PASI50) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved PASI50 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 20, 24, 28, 36, and 48
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75% Improvement (PASI75) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved PASI75 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 20, 24, 28, 36, and 48
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90% Improvement (PASI90) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved PASI90 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 20, 24, 28, 36, and 48
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index 100% Improvement (PASI100) Response at Weeks 4, 8, 12, and 16 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 4, 8, 12, and 16
measure: Percentage of Participants Who Achieved PASI100 Response at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriasis Covering ≥ 3% of the BSA at Baseline
timeFrame: Weeks 20, 24, 28, 36, and 48
measure: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline
timeFrame: Baseline, 20, 24, 28, 36, and 48 weeks
measure: Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline
timeFrame: Baseline, 20, 24, 28, 36, and 48 weeks
measure: Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline
timeFrame: Baseline, 20, 24, 28, 36, and 48 weeks
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
timeFrame: Baseline, 2, 4, 8, 12, and 16 weeks
measure: Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60
timeFrame: Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
measure: Change From Baseline in FACIT-Fatigue Scale Score at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
measure: Change From Baseline in MCS of the SF-36v2 at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16
timeFrame: Baseline, 4, and 16 weeks
measure: Change From Baseline in PCS of the SF-36v2 at Week 48
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: DeBary
country: United States
facility: Omega Research Debary, LLC
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc.
state: Florida
city: Decatur
country: United States
facility: Jefrey D. Lieberman, ND, P.C.
state: Georgia
city: Lexington
country: United States
facility: Bluegrass Community Research, Inc.
state: Kentucky
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Saint Clair Shores
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology, P.A.
state: Minnesota
city: Saint Louis
country: United States
facility: Arthritis Consultants, Inc.
state: Missouri
city: Toms River
country: United States
facility: Atlantic Coast Research
state: New Jersey
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source Inc
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arthritis Group, PC
state: Pennsylvania
city: Wyomissing
country: United States
facility: PA Regional Center for Arthritis and Osteoporosis Research
state: Pennsylvania
city: Columbia
country: United States
facility: Articularis Healthcare Inc, dba, Columbia Arthritis Center, PA
state: South Carolina
city: Orangeburg
country: United States
facility: ACME Research, LLC
state: South Carolina
city: College Station
country: United States
facility: Arthritis & Osteoporosis Clinic of Brazos Valley (Drug Shipment Address)
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC
state: Texas
city: South Charleston
country: United States
facility: West Virginia Research Institute PLLC
state: West Virginia
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
city: Quebec
country: Canada
facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
city: Pardubice
country: Czechia
facility: CCR Czech a.s.
city: Uherske Hradiste
country: Czechia
facility: Reumatologie a Osteologie MEDICAL PLUS s.r.o., Rezidence Hradebni, Obchodni 1507, Uherske Hradiste, 68601
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Gyula
country: Hungary
facility: Bekes Megeyi Kozponti Korhaz, Reumatologiai Osztaly
city: Szentes
country: Hungary
facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly
city: Hachioji-shi
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Kawachinagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
city: Nagoya-City
country: Japan
facility: Nagoya City University Hospital
city: Nagoya
country: Japan
facility: Daido Clinic
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
city: Bialystok, Podlaskie
country: Poland
facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
city: Dabrówka
country: Poland
facility: NSZOZ Unica CR
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Warsaw
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Warszawa, Mazowieckie
country: Poland
facility: ARS RHEUMATICA Sp. Z.o.o.
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Warszawa Targowek
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada - Rheumatology Department, Camino Del Molino no 2, Fuenlabrada, Madrid, 28942
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre, Avenida de Cordoba, s/n, Madrid, Spain, 28041
city: Madrid
country: Spain
facility: Hospital Universitario La Paz. Paseo de la Castellana 261, Madrid, 28046
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli, Parc Tauli 1, Rheumatology Service, Sabadell, Barcelona, 08208
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla, Rheumatology Service, Avda. Valdecilla s/n, 39008
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia, Avenida Blasco Ibáñez, 17 Rheumatology Service, Valencia, Spain,
city: Dailin Township
country: Taiwan
facility: Buddhist Dalin Tzu Chi Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: