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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02886728




Registration number
NCT02886728
Ethics application status
Date submitted
29/08/2016
Date registered
1/09/2016

Titles & IDs
Public title
Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
Scientific title
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy
Secondary ID [1] 0 0
2016-000570-37
Secondary ID [2] 0 0
GS-US-417-0303
Universal Trial Number (UTN)
Trial acronym
FINCH 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

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

Experimental: Filgotinib 200 mg + MTX - Filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg

Experimental: Filgotinib 100 mg + MTX - Filgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg

Experimental: Filgotinib 200 mg Monotherapy - Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX

Active comparator: MTX Monotherapy - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg


Treatment: Drugs: Filgotinib
Tablet(s) administered orally once daily

Treatment: Drugs: Placebo to match filgotinib
Tablet(s) administered orally once daily

Treatment: Drugs: MTX
Capsule(s) administered orally once weekly

Treatment: Drugs: Placebo to match MTX
Capsule(s) administered orally once weekly
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 (ACR20) Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Timepoint [1] 0 0
Baseline; Week 24
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24
Timepoint [3] 0 0
Baseline; Week 24
Secondary outcome [4] 0 0
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Timepoint [4] 0 0
Baseline; Week 24
Secondary outcome [5] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24
Timepoint [5] 0 0
Baseline; Week 24
Secondary outcome [6] 0 0
Change From Baseline in the mTSS at Week 52
Timepoint [6] 0 0
Baseline; Week 52
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52
Timepoint [7] 0 0
Weeks 2, 4, 12, 36, and 52
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [8] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [9] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [10] 0 0
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52
Timepoint [10] 0 0
Baseline; Weeks 2, 4, 12, 36, and 52
Secondary outcome [11] 0 0
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [11] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [12] 0 0
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [12] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [13] 0 0
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [13] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [14] 0 0
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [14] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [15] 0 0
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [15] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [16] 0 0
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [16] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [17] 0 0
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [17] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [18] 0 0
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [18] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [19] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 4, 12, 24, and 52
Timepoint [19] 0 0
Weeks 4, 12, 24, and 52
Secondary outcome [20] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52
Timepoint [20] 0 0
Weeks 2, 4, 12, 36, and 52
Secondary outcome [21] 0 0
ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [21] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [22] 0 0
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [22] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [23] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [23] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [24] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [24] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [25] 0 0
Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52
Timepoint [25] 0 0
Baseline; Weeks 24, and 52
Secondary outcome [26] 0 0
SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52
Timepoint [26] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [27] 0 0
Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52
Timepoint [27] 0 0
Baseline; Weeks 4, 12, 36, and 52
Secondary outcome [28] 0 0
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52
Timepoint [28] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [29] 0 0
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52
Timepoint [29] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [30] 0 0
FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52
Timepoint [30] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [31] 0 0
Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52
Timepoint [31] 0 0
Baseline; Weeks 4, 12, 36, and 52
Secondary outcome [32] 0 0
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52
Timepoint [32] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [33] 0 0
EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
Timepoint [33] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [34] 0 0
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
Timepoint [34] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [35] 0 0
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
Timepoint [35] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [36] 0 0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
Timepoint [36] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [37] 0 0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Timepoint [37] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [38] 0 0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Timepoint [38] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [39] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
Timepoint [39] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [40] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
Timepoint [40] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [41] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Timepoint [41] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [42] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
Timepoint [42] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52

Eligibility
Key inclusion criteria
Key

* Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria) and are ACR functional class I-III.
* Have = 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and = 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
* Limited or no prior treatment with MTX

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous treatment with any janus kinase (JAK) inhibitor
* Previous therapy for longer than 3 months with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine
* Use of any licensed or investigational biologic disease-modifying antirheumatic drugs (DMARDs)

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/05/2019
Sample size
Target
Accrual to date
Final
1252
Recruitment in Australia
Recruitment state(s)
QLD,TAS,WA
Recruitment hospital [1] 0 0
- Maroochydore
Recruitment hospital [2] 0 0
- Hobart
Recruitment hospital [3] 0 0
- Victoria Park
Recruitment postcode(s) [1] 0 0
- Maroochydore
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment postcode(s) [3] 0 0
- Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Florida
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Illinois
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Kansas
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Kentucky
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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New Hampshire
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New Mexico
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North Carolina
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Oklahoma
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South Carolina
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Tennessee
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Texas
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Argentina
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Caba
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Mendoza
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Argentina
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Quilmes
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San Juan
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San Miguel de Tucumán
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Flemish Brabant
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Belgium
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Genk
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Belgium
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Hasselt
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Dobrich
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Haskovo
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Sofia
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Varna
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Vidin
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Ontario
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Quebec
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Temuco
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Ostrava
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Czechia
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Prague 2
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Czechia
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Praha 4
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Czechia
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Uherske Hradiste
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Aachen
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Germany
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Lucknow
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Mangalore
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India
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Mysuru
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Nagpur
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New Delhi
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Pune
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Secunderabad
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Srikakulam
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Surat
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Gdynia
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Torun
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Mures
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Romania
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Oradea
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Russian Federation
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Barnaul
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Saratov
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Slovakia
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Bratislava
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Slovakia
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Prievidza
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Slovakia
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Topol'cany
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South Africa
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Cape Town
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Durban
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Barcelona
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La Coruña
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Málaga
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Sabadell
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Spain
State/province [143] 0 0
Santiago de Compostela
Country [144] 0 0
Spain
State/province [144] 0 0
Valencia
Country [145] 0 0
Taiwan
State/province [145] 0 0
Kaohsiung
Country [146] 0 0
Taiwan
State/province [146] 0 0
Taichung
Country [147] 0 0
Taiwan
State/province [147] 0 0
Tainan
Country [148] 0 0
Taiwan
State/province [148] 0 0
Taipei
Country [149] 0 0
Taiwan
State/province [149] 0 0
Taoyuan
Country [150] 0 0
Thailand
State/province [150] 0 0
Bangkok
Country [151] 0 0
Thailand
State/province [151] 0 0
Chiang Mai
Country [152] 0 0
Thailand
State/province [152] 0 0
Songkhla
Country [153] 0 0
Ukraine
State/province [153] 0 0
Dnipro
Country [154] 0 0
Ukraine
State/province [154] 0 0
Kharkiv
Country [155] 0 0
Ukraine
State/province [155] 0 0
Kherson
Country [156] 0 0
Ukraine
State/province [156] 0 0
Kyiv
Country [157] 0 0
Ukraine
State/province [157] 0 0
L'viv
Country [158] 0 0
Ukraine
State/province [158] 0 0
Vinnitsa
Country [159] 0 0
Ukraine
State/province [159] 0 0
Vinnytsya
Country [160] 0 0
Ukraine
State/province [160] 0 0
Zaporizhzhya
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Edinburgh
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Newcastle upon Tyne

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
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

TypeCitations or Other Details
Journal Westhovens R, Rigby W, van der Heijde D, Ching D, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02886728