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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04115839




Registration number
NCT04115839
Ethics application status
Date submitted
2/10/2019
Date registered
4/10/2019

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2019-002021-29
Secondary ID [2] 0 0
GS-US-431-4567
Universal Trial Number (UTN)
Trial acronym
PENGUIN 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib

Experimental: Filgotinib 200 mg (Main Study) - Participants will receive filgotinib 200 mg + placebo to match (PTM) filgotinib 100 mg for up to 16 weeks.

Experimental: Filgotinib 100 mg (Main Study) - Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 16 weeks.

Placebo comparator: Placebo (Main Study) - Participants will receive PTM filgotinib 200 mg + PTM filgotinib 100 mg for up to 16 weeks.

Experimental: Filgotinib 200 mg (LTE) - Participants will receive filgotinib 200 mg + PTM filgotinib 100 mg for up to 44 weeks.

Experimental: Filgotinib 100 mg (LTE) - Participants will receive PTM filgotinib 200 mg + filgotinib 100 mg for up to 44 weeks.


Treatment: Drugs: Filgotinib
Tablets will be administered orally once daily with or without food.

Treatment: Drugs: Placebo to match filgotinib
Tablets administered orally once daily with or without food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4 and 16
Timepoint [1] 0 0
Baseline, 4, and 16 weeks
Secondary outcome [2] 0 0
Change From Baseline in PASDAS at Week 48
Timepoint [2] 0 0
Baseline, Week 48
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) Response at Weeks 4, 8, 12, and 16
Timepoint [3] 0 0
Weeks 4, 8, 12, and 16
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved MDA Response at Weeks 20, 24, 28, 36, and 48
Timepoint [4] 0 0
Weeks 20, 24, 28, 36, and 48
Secondary outcome [5] 0 0
Percentage of Participants Who Achieved Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, and 16
Timepoint [5] 0 0
Weeks 4, 8, 12, and 16
Secondary outcome [6] 0 0
Percentage of Participants Who Achieved VLDA Response at Weeks 20, 24, 28, 36, and 48
Timepoint [6] 0 0
Weeks 20, 24, 28, 36, and 48
Secondary outcome [7] 0 0
Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) at Weeks 2, 4, 8, 12, and 16
Timepoint [7] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [8] 0 0
Change From Baseline in DAPSA at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [8] 0 0
Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Baseline, 18, 20, 24, 28, 36, and 48 weeks
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Baseline, 4, 8, 12, and 16 weeks
Secondary outcome [12] 0 0
Change From Baseline in mNAPSI at Weeks 20, 24, 28, 36, and 48 in Participants With Psoriatic Nail Involvement at Baseline
Timepoint [12] 0 0
Baseline, 20, 24, 28, 36, and 48 weeks
Secondary outcome [13] 0 0
Change From Baseline in Leeds Enthesitis Index (LEI) at Weeks 4, 8, 12, and 16 in Participants With Enthesitis at Baseline
Timepoint [13] 0 0
Baseline, 4, 8, 12, and 16 weeks
Secondary outcome [14] 0 0
Change From Baseline in LEI at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline
Timepoint [14] 0 0
Baseline, 20, 24, 28, 36, and 48 weeks
Secondary outcome [15] 0 0
Change From Baseline in 12-Item Psoriatic Arthritis Impact of Disease (PsAID-12) Score at Weeks 4 and 16
Timepoint [15] 0 0
Baseline, 4, and 16 weeks
Secondary outcome [16] 0 0
Change From Baseline in PsAID-12 Score at Week 48
Timepoint [16] 0 0
Baseline, Week 48
Secondary outcome [17] 0 0
Percentage of Participants With PASDAS Low Disease Activity (LDA) at Weeks 4 and 16
Timepoint [17] 0 0
Weeks 4 and 16
Secondary outcome [18] 0 0
Percentage of Participants With PASDAS LDA at Week 48
Timepoint [18] 0 0
Week 48
Secondary outcome [19] 0 0
Percentage of Participants Who Achieved PASDAS Remission at Weeks 4 and 16
Timepoint [19] 0 0
Weeks 4 and 16
Secondary outcome [20] 0 0
Percentage of Participants Who Achieved PASDAS Remission at Week 48
Timepoint [20] 0 0
Week 48
Secondary outcome [21] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 2, 4, 8, 12, and 16
Timepoint [21] 0 0
Weeks 2, 4, 8, 12, and 16
Secondary outcome [22] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology 20% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [22] 0 0
Weeks 18, 20, 24, 28, 36, 48, and 60
Secondary outcome [23] 0 0
Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 2, 4, 8, 12, and 16
Timepoint [23] 0 0
Weeks 2, 4, 8, 12, and 16
Secondary outcome [24] 0 0
Percentage of Participants Who Achieve an American College of Rheumatology 50% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [24] 0 0
Weeks 18, 20, 24, 28, 36, 48, and 60
Secondary outcome [25] 0 0
Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 2, 4, 8, 12, and 16
Timepoint [25] 0 0
Weeks 2, 4, 8, 12, and 16
Secondary outcome [26] 0 0
Percentage of Participants Who Achieve an American College of Rheumatology 70% Improvement Response at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [26] 0 0
Weeks 18, 20, 24, 28, 36, 48, and 60
Secondary outcome [27] 0 0
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 8, 12, and 16
Timepoint [27] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [28] 0 0
Change From Baseline in Individual ACR Component: TJC68 at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [28] 0 0
Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Secondary outcome [29] 0 0
Change From Baseline in ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 8, 12, and 16
Timepoint [29] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [30] 0 0
Change From Baseline in ACR Component: SJC66 at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [30] 0 0
Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Secondary outcome [31] 0 0
Change From Baseline in Individual ACR Component: Patient's Global Assessment of Disease Activity (PGADA) at Weeks 2, 4, 8, 12, and 16
Timepoint [31] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [32] 0 0
Change From Baseline in Individual ACR Component: PGADA at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [32] 0 0
Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Secondary outcome [33] 0 0
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PhGADA) at Weeks 2, 4, 8, 12, and 16
Timepoint [33] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [34] 0 0
Change From Baseline in Individual ACR Component: PhGADA at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [34] 0 0
Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Secondary outcome [35] 0 0
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
Timepoint [35] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [36] 0 0
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
Timepoint [36] 0 0
Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Secondary outcome [37] 0 0
Change From Baseline in Individual ACR Component: High-Sensitivity C- Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, and 16
Timepoint [37] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [38] 0 0
Change From Baseline in Individual ACR Component: hsCRP at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [38] 0 0
Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Secondary outcome [39] 0 0
Change From Baseline in Disease Activity Score 28 (DAS28) C-Reactive Protein (CRP) at Weeks 2, 4, 8, 12, and 16
Timepoint [39] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [40] 0 0
Change From Baseline in DAS28(CRP) at Weeks 18, 20, 24, 28, 36, 48 and 60
Timepoint [40] 0 0
Baseline, 18, 20, 24, 28, 36, 48 and 60 weeks
Secondary outcome [41] 0 0
Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 2, 4, 8, 12, and 16
Timepoint [41] 0 0
Weeks 2, 4, 8, 12, and 16
Secondary outcome [42] 0 0
Percentage of Participants Who Achieved DAS28(CRP) LDA at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [42] 0 0
Weeks 18, 20, 24, 28, 36, 48, and 60
Secondary outcome [43] 0 0
Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 2, 4, 8, 12, and 16
Timepoint [43] 0 0
Weeks 2, 4, 8, 12, and 16
Secondary outcome [44] 0 0
Percentage of Participants Who Achieved DAS28(CRP) Remission at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [44] 0 0
Weeks 18, 20, 24, 28, 36, 48, and 60
Secondary outcome [45] 0 0
Time to Achieve DAS28(CRP) LDA
Timepoint [45] 0 0
Approximately 16 weeks
Secondary outcome [46] 0 0
Percentage of Participants Who Achieved DAPSA LDA at Weeks 2, 4, 8, 12, and 16
Timepoint [46] 0 0
Weeks 2, 4, 8, 12, and 16
Secondary outcome [47] 0 0
Percentage of Participants Who Achieved DAPSA LDA at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [47] 0 0
Weeks 18, 20, 24, 28, 36, 48, and 60
Secondary outcome [48] 0 0
Percentage of Participants Who Achieved DAPSA Remission at Weeks 2, 4, 8, 12, and 16
Timepoint [48] 0 0
Weeks 2, 4, 8, 12, and 16
Secondary outcome [49] 0 0
Percentage of Participants Who Achieved DAPSA Remission at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [49] 0 0
Weeks 18, 20, 24, 28, 36, 48, and 60
Secondary outcome [50] 0 0
Time to Achieve DAPSA LDA
Timepoint [50] 0 0
Approximately 16 weeks
Secondary outcome [51] 0 0
Percentage of Participants Who Achieved Psoriatic Arthritis Response Criteria (PsARC) Response at Weeks 2, 4, 8, 12, and 16
Timepoint [51] 0 0
Weeks 2, 4, 8, 12, and 16
Secondary outcome [52] 0 0
Percentage of Participants Who Achieved PsARC Response at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [52] 0 0
Weeks 18, 20, 24, 28, 36, 48, and 60
Secondary outcome [53] 0 0
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
Timepoint [53] 0 0
Baseline, 4, 8, 12, and 16 weeks
Secondary outcome [54] 0 0
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
Timepoint [54] 0 0
Baseline, 20, 24, 28, 36, and 48 weeks
Secondary outcome [55] 0 0
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
Timepoint [55] 0 0
Weeks 4, 8, 12, and 16
Secondary outcome [56] 0 0
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
Timepoint [56] 0 0
Weeks 20, 24, 28, 36, and 48
Secondary outcome [57] 0 0
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
Timepoint [57] 0 0
Weeks 4, 8, 12, and 16
Secondary outcome [58] 0 0
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
Timepoint [58] 0 0
Weeks 20, 24, 28, 36, and 48
Secondary outcome [59] 0 0
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
Timepoint [59] 0 0
Weeks 4, 8, 12, and 16
Secondary outcome [60] 0 0
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
Timepoint [60] 0 0
Weeks 20, 24, 28, 36, and 48
Secondary outcome [61] 0 0
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
Timepoint [61] 0 0
Weeks 4, 8, 12, and 16
Secondary outcome [62] 0 0
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
Timepoint [62] 0 0
Weeks 20, 24, 28, 36, and 48
Secondary outcome [63] 0 0
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
Timepoint [63] 0 0
Baseline, 4, 8, 12, and 16 weeks
Secondary outcome [64] 0 0
Change From Baseline in SPARCC Enthesitis Index at Weeks 20, 24, 28, 36, and 48 in Participants With Enthesitis at Baseline
Timepoint [64] 0 0
Baseline, 20, 24, 28, 36, and 48 weeks
Secondary outcome [65] 0 0
Change From Baseline in Leeds Dactylitis Index (LDI) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Timepoint [65] 0 0
Baseline, 4, 8, 12, and 16 weeks
Secondary outcome [66] 0 0
Change From Baseline in LDI at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline
Timepoint [66] 0 0
Baseline, 20, 24, 28, 36, and 48 weeks
Secondary outcome [67] 0 0
Change From Baseline in Tender Dactylitis Count (TDC) at Weeks 4, 8, 12, and 16 in Participants With Dactylitis at Baseline
Timepoint [67] 0 0
Baseline, 4, 8, 12, and 16 weeks
Secondary outcome [68] 0 0
Change From Baseline in TDC at Weeks 20, 24, 28, 36, and 48 in Participants With Dactylitis at Baseline
Timepoint [68] 0 0
Baseline, 20, 24, 28, 36, and 48 weeks
Secondary outcome [69] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, and 16
Timepoint [69] 0 0
Baseline, 2, 4, 8, 12, and 16 weeks
Secondary outcome [70] 0 0
Change From Baseline in HAQ-DI Score at Weeks 18, 20, 24, 28, 36, 48, and 60
Timepoint [70] 0 0
Baseline, 18, 20, 24, 28, 36, 48, and 60 weeks
Secondary outcome [71] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Score at Weeks 4 and 16
Timepoint [71] 0 0
Baseline, 4, and 16 weeks
Secondary outcome [72] 0 0
Change From Baseline in FACIT-Fatigue Scale Score at Week 48
Timepoint [72] 0 0
Baseline, Week 48
Secondary outcome [73] 0 0
Change From Baseline in Mental Component Score (MCS) of the 36-Item Short-Form Version 2 (SF-36v2) at Weeks 4 and 16
Timepoint [73] 0 0
Baseline, 4, and 16 weeks
Secondary outcome [74] 0 0
Change From Baseline in MCS of the SF-36v2 at Week 48
Timepoint [74] 0 0
Baseline, Week 48
Secondary outcome [75] 0 0
Change From Baseline in Physical Component Score (PCS) of the SF-36v2 at Weeks 4 and 16
Timepoint [75] 0 0
Baseline, 4, and 16 weeks
Secondary outcome [76] 0 0
Change From Baseline in PCS of the SF-36v2 at Week 48
Timepoint [76] 0 0
Baseline, Week 48

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/03/2021
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [3] 0 0
Emeritus Research - Camberwell
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
West Virginia
Country [16] 0 0
Belgium
State/province [16] 0 0
Yvoir
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Czechia
State/province [18] 0 0
Pardubice
Country [19] 0 0
Czechia
State/province [19] 0 0
Uherske Hradiste
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Hungary
State/province [21] 0 0
Gyula
Country [22] 0 0
Hungary
State/province [22] 0 0
Szentes
Country [23] 0 0
Japan
State/province [23] 0 0
Hachioji-shi
Country [24] 0 0
Japan
State/province [24] 0 0
Kawachinagano
Country [25] 0 0
Japan
State/province [25] 0 0
Nagoya-City
Country [26] 0 0
Japan
State/province [26] 0 0
Nagoya
Country [27] 0 0
Japan
State/province [27] 0 0
Tokyo
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Incheon
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Poland
State/province [30] 0 0
Bialystok, Podlaskie
Country [31] 0 0
Poland
State/province [31] 0 0
Dabrówka
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Katowice
Country [34] 0 0
Poland
State/province [34] 0 0
Warsaw
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa, Mazowieckie
Country [36] 0 0
Poland
State/province [36] 0 0
Warszawa
Country [37] 0 0
Poland
State/province [37] 0 0
Wroclaw
Country [38] 0 0
Spain
State/province [38] 0 0
Fuenlabrada
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Sabadell
Country [41] 0 0
Spain
State/province [41] 0 0
Santander
Country [42] 0 0
Spain
State/province [42] 0 0
Sevilla
Country [43] 0 0
Spain
State/province [43] 0 0
Valencia
Country [44] 0 0
Taiwan
State/province [44] 0 0
Dailin Township
Country [45] 0 0
Taiwan
State/province [45] 0 0
Tainan
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Galapagos NV
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04115839