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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02889796




Registration number
NCT02889796
Ethics application status
Date submitted
31/08/2016
Date registered
7/09/2016
Date last updated
9/06/2021

Titles & IDs
Public title
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
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 in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Secondary ID [1] 0 0
2016-000568-41
Secondary ID [2] 0 0
GS-US-417-0301
Universal Trial Number (UTN)
Trial acronym
FINCH 1
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 - Adalimumab
Treatment: Drugs - Placebo to match adalimumab
Treatment: Drugs - MTX

Experimental: Filgotinib 200 mg - Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)

Experimental: Filgotinib 100 mg - Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX

Active comparator: Adalimumab - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX

Experimental: Placebo to Filgotinib 200 mg - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 200 mg to receive filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

Experimental: Placebo to Filgotinib 100 mg - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

Placebo comparator: Placebo Never Received Filgotinib - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks.


Treatment: Drugs: Filgotinib
200 mg or 100 mg tablet(s) administered orally once daily

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

Treatment: Drugs: Adalimumab
40 mg administered via subcutaneous injection once every two weeks

Treatment: Drugs: Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks

Treatment: Drugs: MTX
Commercially sourced tablet(s) administered orally
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 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Timepoint [1] 0 0
Baseline; Week 12
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 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
Timepoint [3] 0 0
Baseline; Week 24
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
Timepoint [5] 0 0
Baseline; Week 12
Secondary outcome [6] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
Timepoint [6] 0 0
Baseline; Week 12
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24
Timepoint [7] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52
Timepoint [8] 0 0
Weeks 36, and 52
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24
Timepoint [9] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [10] 0 0
Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52
Timepoint [10] 0 0
Weeks 36, and 52
Secondary outcome [11] 0 0
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24
Timepoint [11] 0 0
Weeks 2, 4, and 24
Secondary outcome [12] 0 0
Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52
Timepoint [12] 0 0
Weeks 36, and 52
Secondary outcome [13] 0 0
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24
Timepoint [13] 0 0
Baseline; Weeks 2, 4, and 24
Secondary outcome [14] 0 0
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52
Timepoint [14] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [15] 0 0
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24
Timepoint [15] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [16] 0 0
Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52
Timepoint [16] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [17] 0 0
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24
Timepoint [17] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [18] 0 0
Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52
Timepoint [18] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [19] 0 0
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24
Timepoint [19] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [20] 0 0
Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52
Timepoint [20] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [21] 0 0
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24
Timepoint [21] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [22] 0 0
Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52
Timepoint [22] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [23] 0 0
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24
Timepoint [23] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [24] 0 0
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52
Timepoint [24] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [25] 0 0
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24
Timepoint [25] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [26] 0 0
Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52
Timepoint [26] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [27] 0 0
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 2, 4, 12, and 24
Timepoint [27] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [28] 0 0
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 36, and 52
Timepoint [28] 0 0
Weeks 36, and 52
Secondary outcome [29] 0 0
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24
Timepoint [29] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [30] 0 0
Change From Baseline in DAS28 (CRP) at Weeks 36, and 52
Timepoint [30] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [31] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 2, 4, and 24
Timepoint [31] 0 0
Weeks 2, 4, and 24
Secondary outcome [32] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 36, and 52
Timepoint [32] 0 0
Weeks 36, and 52
Secondary outcome [33] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24
Timepoint [33] 0 0
Weeks 2, 4, and 24
Secondary outcome [34] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52
Timepoint [34] 0 0
Weeks 36, and 52
Secondary outcome [35] 0 0
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24
Timepoint [35] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [36] 0 0
ACR N Percent Improvement (ACR-N) at Weeks 36, and 52
Timepoint [36] 0 0
Weeks 36, and 52
Secondary outcome [37] 0 0
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24
Timepoint [37] 0 0
Weeks 2, 4, 12, and 24
Secondary outcome [38] 0 0
Number of Participants With EULAR Response at Weeks 36, and 52
Timepoint [38] 0 0
Weeks 36, and 52
Secondary outcome [39] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24
Timepoint [39] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [40] 0 0
Change From Baseline in CDAI at Weeks 36, and 52
Timepoint [40] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [41] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24
Timepoint [41] 0 0
Baseline; Weeks 2, 4, 12, and 24
Secondary outcome [42] 0 0
Change From Baseline in SDAI at Weeks 36, and 52
Timepoint [42] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [43] 0 0
Change From Baseline in mTSS at Week 52
Timepoint [43] 0 0
Baseline; Week 52
Secondary outcome [44] 0 0
Percentage of Participants With no Radiographic Progression From Baseline at Week 24
Timepoint [44] 0 0
Baseline; Weeks 24
Secondary outcome [45] 0 0
Percentage of Participants With no Radiographic Progression From Baseline at Week 52
Timepoint [45] 0 0
Baseline; Week 52
Secondary outcome [46] 0 0
36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24
Timepoint [46] 0 0
Weeks 4, 12, and 24
Secondary outcome [47] 0 0
SF-36 PCS Score at Weeks 36, and 52
Timepoint [47] 0 0
Weeks 36, and 52
Secondary outcome [48] 0 0
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
Timepoint [48] 0 0
Baseline; Weeks 4, and 24
Secondary outcome [49] 0 0
Change From Baseline in SF-36 PCS Score at Weeks 36, and 52
Timepoint [49] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [50] 0 0
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
Timepoint [50] 0 0
Weeks 4, 12, and 24
Secondary outcome [51] 0 0
SF-36 MCS Score at Weeks 36, and 52
Timepoint [51] 0 0
Weeks 36, and 52
Secondary outcome [52] 0 0
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
Timepoint [52] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [53] 0 0
Change From Baseline in SF-36 MCS Score at Weeks 36, and 52
Timepoint [53] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [54] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24
Timepoint [54] 0 0
Weeks 4, 12, and 24
Secondary outcome [55] 0 0
FACIT-Fatigue Score at Weeks 36, and 52
Timepoint [55] 0 0
Weeks 36, and 52
Secondary outcome [56] 0 0
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
Timepoint [56] 0 0
Baseline; Weeks 4, and 24
Secondary outcome [57] 0 0
Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52
Timepoint [57] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [58] 0 0
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Timepoint [58] 0 0
Weeks 4, 12, and 24
Secondary outcome [59] 0 0
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52
Timepoint [59] 0 0
Weeks 36, and 52
Secondary outcome [60] 0 0
EQ-5D Current Health VAS at Weeks 4, 12, and 24
Timepoint [60] 0 0
Weeks 4, 12, and 24
Secondary outcome [61] 0 0
EQ-5D Current Health VAS at Weeks 36, and 52
Timepoint [61] 0 0
Weeks 36, and 52
Secondary outcome [62] 0 0
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
Timepoint [62] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [63] 0 0
Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52
Timepoint [63] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [64] 0 0
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Timepoint [64] 0 0
Weeks 4, 12, and 24
Secondary outcome [65] 0 0
WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
Timepoint [65] 0 0
Weeks 36, and 52
Secondary outcome [66] 0 0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Timepoint [66] 0 0
Weeks 4, 12, and 24
Secondary outcome [67] 0 0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
Timepoint [67] 0 0
Weeks 36, and 52
Secondary outcome [68] 0 0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [68] 0 0
Weeks 4, 12, and 24
Secondary outcome [69] 0 0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
Timepoint [69] 0 0
Weeks 36, and 52
Secondary outcome [70] 0 0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [70] 0 0
Weeks 4, 12, and 24
Secondary outcome [71] 0 0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
Timepoint [71] 0 0
Weeks 36, and 52
Secondary outcome [72] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Timepoint [72] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [73] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
Timepoint [73] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [74] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Timepoint [74] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [75] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
Timepoint [75] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [76] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [76] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [77] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
Timepoint [77] 0 0
Baseline; Weeks 36, and 52
Secondary outcome [78] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [78] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [79] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
Timepoint [79] 0 0
Baseline; Weeks 36, and 52

Eligibility
Key inclusion criteria
Key

* Have a diagnosis of rheumatoid arthritis (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.
* Ongoing treatment with a stable dose of 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

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
30/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/06/2019
Sample size
Target
Accrual to date
Final
1759
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
- Victoria Park
Recruitment postcode(s) [1] 0 0
- Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Caba
Country [21] 0 0
Argentina
State/province [21] 0 0
Mendoza
Country [22] 0 0
Argentina
State/province [22] 0 0
Quilmes
Country [23] 0 0
Argentina
State/province [23] 0 0
San Fernando
Country [24] 0 0
Argentina
State/province [24] 0 0
San Juan
Country [25] 0 0
Argentina
State/province [25] 0 0
San Miguel De Tucumán
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussels
Country [27] 0 0
Belgium
State/province [27] 0 0
Genk
Country [28] 0 0
Belgium
State/province [28] 0 0
Merksem
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Dobrich
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Haskovo
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Varna
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Vidin
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Czechia
State/province [36] 0 0
Praha
Country [37] 0 0
Czechia
State/province [37] 0 0
Brno
Country [38] 0 0
Czechia
State/province [38] 0 0
Ostrava-Poruba
Country [39] 0 0
Czechia
State/province [39] 0 0
Ostrava
Country [40] 0 0
Czechia
State/province [40] 0 0
Prague 10
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 4
Country [42] 0 0
Czechia
State/province [42] 0 0
Uherske Hradiste
Country [43] 0 0
Germany
State/province [43] 0 0
Frankfurt a Main
Country [44] 0 0
Germany
State/province [44] 0 0
Hamburg
Country [45] 0 0
Germany
State/province [45] 0 0
Ratingen
Country [46] 0 0
Hong Kong
State/province [46] 0 0
Hong Kong
Country [47] 0 0
Hungary
State/province [47] 0 0
Bacs-kiskun
Country [48] 0 0
Hungary
State/province [48] 0 0
Csongrad
Country [49] 0 0
Hungary
State/province [49] 0 0
Fejer
Country [50] 0 0
Hungary
State/province [50] 0 0
Budapest
Country [51] 0 0
Hungary
State/province [51] 0 0
Eger
Country [52] 0 0
India
State/province [52] 0 0
Ahmedabad
Country [53] 0 0
India
State/province [53] 0 0
Bangalore
Country [54] 0 0
India
State/province [54] 0 0
Chennai
Country [55] 0 0
India
State/province [55] 0 0
Delhi
Country [56] 0 0
India
State/province [56] 0 0
Gurgaon
Country [57] 0 0
India
State/province [57] 0 0
Hyderabad
Country [58] 0 0
India
State/province [58] 0 0
Jaipur
Country [59] 0 0
India
State/province [59] 0 0
Kolkata
Country [60] 0 0
India
State/province [60] 0 0
Lucknow
Country [61] 0 0
India
State/province [61] 0 0
Mangalore
Country [62] 0 0
India
State/province [62] 0 0
Nagpur
Country [63] 0 0
India
State/province [63] 0 0
New Delhi
Country [64] 0 0
India
State/province [64] 0 0
Pune
Country [65] 0 0
India
State/province [65] 0 0
Secunderabad
Country [66] 0 0
India
State/province [66] 0 0
Srikakulam
Country [67] 0 0
India
State/province [67] 0 0
Surat
Country [68] 0 0
India
State/province [68] 0 0
Vadodara
Country [69] 0 0
India
State/province [69] 0 0
Visakhapatnam
Country [70] 0 0
Ireland
State/province [70] 0 0
Dublin 4
Country [71] 0 0
Israel
State/province [71] 0 0
Haifa
Country [72] 0 0
Israel
State/province [72] 0 0
Tel Aviv
Country [73] 0 0
Israel
State/province [73] 0 0
Tel-Hashomer
Country [74] 0 0
Italy
State/province [74] 0 0
Bologna
Country [75] 0 0
Italy
State/province [75] 0 0
Catania
Country [76] 0 0
Italy
State/province [76] 0 0
Milano
Country [77] 0 0
Japan
State/province [77] 0 0
Chiba-shi
Country [78] 0 0
Japan
State/province [78] 0 0
Fukuoka
Country [79] 0 0
Japan
State/province [79] 0 0
Hiroshima
Country [80] 0 0
Japan
State/province [80] 0 0
Iizuka-shi
Country [81] 0 0
Japan
State/province [81] 0 0
Iruma-gun
Country [82] 0 0
Japan
State/province [82] 0 0
Izumo
Country [83] 0 0
Japan
State/province [83] 0 0
Kagoshima-shi
Country [84] 0 0
Japan
State/province [84] 0 0
Kato
Country [85] 0 0
Japan
State/province [85] 0 0
Kitakyushu-shi
Country [86] 0 0
Japan
State/province [86] 0 0
Kobe
Country [87] 0 0
Japan
State/province [87] 0 0
Kumamoto
Country [88] 0 0
Japan
State/province [88] 0 0
Kurume-shi
Country [89] 0 0
Japan
State/province [89] 0 0
Kyoto-shi
Country [90] 0 0
Japan
State/province [90] 0 0
Kyoto
Country [91] 0 0
Japan
State/province [91] 0 0
Miyazaki
Country [92] 0 0
Japan
State/province [92] 0 0
Morioka
Country [93] 0 0
Japan
State/province [93] 0 0
Nagaoka
Country [94] 0 0
Japan
State/province [94] 0 0
Nagasaki-shi
Country [95] 0 0
Japan
State/province [95] 0 0
Nagasaki
Country [96] 0 0
Japan
State/province [96] 0 0
Nagoya
Country [97] 0 0
Japan
State/province [97] 0 0
Narashino
Country [98] 0 0
Japan
State/province [98] 0 0
Nishinomiya
Country [99] 0 0
Japan
State/province [99] 0 0
Sanuki-shi
Country [100] 0 0
Japan
State/province [100] 0 0
Sapporo
Country [101] 0 0
Japan
State/province [101] 0 0
Sasebo-shi
Country [102] 0 0
Japan
State/province [102] 0 0
Sayama-shi
Country [103] 0 0
Japan
State/province [103] 0 0
Shibata-City
Country [104] 0 0
Japan
State/province [104] 0 0
Shinjuku-Ku
Country [105] 0 0
Japan
State/province [105] 0 0
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Country [106] 0 0
Japan
State/province [106] 0 0
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Country [107] 0 0
Japan
State/province [107] 0 0
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Country [108] 0 0
Japan
State/province [108] 0 0
Takasaki-shi
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Japan
State/province [109] 0 0
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Country [110] 0 0
Japan
State/province [110] 0 0
Tokyo
Country [111] 0 0
Japan
State/province [111] 0 0
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Country [112] 0 0
Japan
State/province [112] 0 0
Wakayama
Country [113] 0 0
Japan
State/province [113] 0 0
Yokohama-shi
Country [114] 0 0
Japan
State/province [114] 0 0
Oita
Country [115] 0 0
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State/province [115] 0 0
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Country [116] 0 0
Korea, Republic of
State/province [116] 0 0
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Korea, Republic of
State/province [117] 0 0
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State/province [118] 0 0
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State/province [119] 0 0
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State/province [120] 0 0
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State/province [122] 0 0
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State/province [126] 0 0
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Mexico
State/province [127] 0 0
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Country [128] 0 0
Mexico
State/province [128] 0 0
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Mexico
State/province [129] 0 0
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State/province [130] 0 0
Leiden
Country [131] 0 0
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State/province [131] 0 0
Auckland
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State/province [132] 0 0
Hamilton
Country [133] 0 0
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State/province [133] 0 0
Newtown
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State/province [134] 0 0
Timaru
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Poland
State/province [135] 0 0
Dolnoslaskie
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Poland
State/province [136] 0 0
Bialystok
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Poland
State/province [137] 0 0
Bydgoszcz
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Poland
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Country [139] 0 0
Poland
State/province [139] 0 0
Elblag
Country [140] 0 0
Poland
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Gdynia
Country [141] 0 0
Poland
State/province [141] 0 0
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Poland
State/province [142] 0 0
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Poland
State/province [144] 0 0
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Poland
State/province [145] 0 0
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Poland
State/province [146] 0 0
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Poland
State/province [147] 0 0
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Country [148] 0 0
Poland
State/province [148] 0 0
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Poland
State/province [149] 0 0
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Country [150] 0 0
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State/province [150] 0 0
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Country [151] 0 0
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State/province [151] 0 0
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Romania
State/province [152] 0 0
Bacau
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Romania
State/province [153] 0 0
Târgu-Mures
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Barnaul
Country [155] 0 0
Russian Federation
State/province [155] 0 0
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Russian Federation
State/province [156] 0 0
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Russian Federation
State/province [157] 0 0
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Russian Federation
State/province [158] 0 0
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Russian Federation
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Russian Federation
State/province [160] 0 0
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Slovakia
State/province [168] 0 0
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State/province [170] 0 0
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Country [171] 0 0
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State/province [171] 0 0
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State/province [172] 0 0
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State/province [173] 0 0
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Country [174] 0 0
Spain
State/province [174] 0 0
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Country [175] 0 0
Spain
State/province [175] 0 0
Sabadell
Country [176] 0 0
Spain
State/province [176] 0 0
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Country [177] 0 0
Spain
State/province [177] 0 0
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Country [178] 0 0
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State/province [178] 0 0
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Country [179] 0 0
Taiwan
State/province [179] 0 0
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Taiwan
State/province [180] 0 0
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Taiwan
State/province [181] 0 0
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Taiwan
State/province [182] 0 0
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Country [183] 0 0
Taiwan
State/province [183] 0 0
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Country [184] 0 0
Taiwan
State/province [184] 0 0
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Country [185] 0 0
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State/province [185] 0 0
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State/province [186] 0 0
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Country [187] 0 0
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State/province [187] 0 0
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State/province [191] 0 0
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Country [193] 0 0
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State/province [193] 0 0
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State/province [194] 0 0
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State/province [197] 0 0
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State/province [198] 0 0
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United Kingdom
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United Kingdom
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Country [203] 0 0
United Kingdom
State/province [203] 0 0
Newcastle Upon Tyne
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Warrington

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
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
Trial website
https://clinicaltrials.gov/study/NCT02889796
Trial related presentations / publications
Combe B, Kivitz A, Tanaka Y, van der Heijde D, Matzkies F, Bartok B, et al. Efficacy and safety of filgotinib for patients with rheumatoid arthritis with inadequate response to methotrexate: FINCH 1 primary outcome results. Ann Rheum Dis 2019; 78 (supplement 2):A77.
Tanaka Y, Atsumi T, Aletaha D, Bartok B, Pechonkina A, Han L, Emoto K, Kano S, Rajendran V, Takeuchi T. Benefit of Filgotinib, a JAK1 Preferential Inhibitor, in Rheumatoid Arthritis Patients with Previous Rapid Radiographic Progression: Post Hoc Analysis of Two Trials. Rheumatol Ther. 2023 Feb;10(1):161-185. doi: 10.1007/s40744-022-00503-3. Epub 2022 Nov 3.
Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.
Bingham CO 3rd, Walker D, Nash P, Lee SJ, Ye L, Hu H, Khalid JM, Combe B. The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies. Arthritis Res Ther. 2022 Jan 3;24(1):11. doi: 10.1186/s13075-021-02677-7.
Combe B, Kivitz A, Tanaka Y, van der Heijde D, Simon JA, Baraf HSB, Kumar U, Matzkies F, Bartok B, Ye L, Guo Y, Tasset C, Sundy JS, Jahreis A, Genovese MC, Mozaffarian N, Landewe RBM, Bae SC, Keystone EC, Nash P. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial. Ann Rheum Dis. 2021 Jul;80(7):848-858. doi: 10.1136/annrheumdis-2020-219214. Epub 2021 Jan 27.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02889796