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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02873936




Registration number
NCT02873936
Ethics application status
Date submitted
17/08/2016
Date registered
22/08/2016

Titles & IDs
Public title
Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment
Secondary ID [1] 0 0
2016-000569-21
Secondary ID [2] 0 0
GS-US-417-0302
Universal Trial Number (UTN)
Trial acronym
FINCH 2
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 - csDMARDs

Experimental: Filgotinib 200 mg - Filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)

Experimental: Filgotinib 100 mg - Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s)

Placebo comparator: Placebo - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)


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

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

Treatment: Drugs: csDMARDs
csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
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)] = 3.2 at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
Timepoint [3] 0 0
Baseline; Week 12
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
Timepoint [5] 0 0
Baseline; Week 12
Secondary outcome [6] 0 0
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24
Timepoint [6] 0 0
Weeks 4, 12, and 24
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24
Timepoint [7] 0 0
Weeks 4, 12, and 24
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24
Timepoint [8] 0 0
Weeks 4, and 24
Secondary outcome [9] 0 0
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24
Timepoint [9] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [10] 0 0
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24
Timepoint [10] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [11] 0 0
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24
Timepoint [11] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [12] 0 0
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24
Timepoint [12] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [13] 0 0
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24
Timepoint [13] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [14] 0 0
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24
Timepoint [14] 0 0
Baseline; Weeks 4, and 24
Secondary outcome [15] 0 0
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24
Timepoint [15] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [16] 0 0
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 4, 12, and 24
Timepoint [16] 0 0
Weeks 4, 12, and 24
Secondary outcome [17] 0 0
Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24
Timepoint [17] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [18] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 4, and 24
Timepoint [18] 0 0
Weeks 4, and 24
Secondary outcome [19] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12
Timepoint [19] 0 0
Weeks 4, and 12
Secondary outcome [20] 0 0
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24
Timepoint [20] 0 0
Weeks 4, 12, and 24
Secondary outcome [21] 0 0
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
Timepoint [21] 0 0
Weeks 4, 12, and 24
Secondary outcome [22] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24
Timepoint [22] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [23] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24
Timepoint [23] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [24] 0 0
SF-36 PCS Score at Weeks 4, 12, and 24
Timepoint [24] 0 0
Weeks 4, 12, and 24
Secondary outcome [25] 0 0
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
Timepoint [25] 0 0
Baseline; Weeks 4, and 24
Secondary outcome [26] 0 0
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
Timepoint [26] 0 0
Weeks 4, 12, and 24
Secondary outcome [27] 0 0
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
Timepoint [27] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [28] 0 0
FACIT-Fatigue Score at Weeks 4, 12, and 24
Timepoint [28] 0 0
Weeks 4, 12, and 24
Secondary outcome [29] 0 0
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
Timepoint [29] 0 0
Baseline; Weeks 4, and 24
Secondary outcome [30] 0 0
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Timepoint [30] 0 0
Weeks 4, 12, and 24
Secondary outcome [31] 0 0
EQ-5D Current Health VAS at Weeks 4, 12, and 24
Timepoint [31] 0 0
Weeks 4, 12, and 24
Secondary outcome [32] 0 0
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
Timepoint [32] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [33] 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 [33] 0 0
Weeks 4, 12, and 24
Secondary outcome [34] 0 0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Timepoint [34] 0 0
Weeks 4, 12, and 24
Secondary outcome [35] 0 0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [35] 0 0
Weeks 4, 12, and 24
Secondary outcome [36] 0 0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [36] 0 0
Weeks 4, 12, and 24
Secondary outcome [37] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Timepoint [37] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [38] 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 [38] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [39] 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 [39] 0 0
Baseline; Weeks 4, 12, and 24
Secondary outcome [40] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Timepoint [40] 0 0
Baseline; Weeks 4, 12, and 24

Eligibility
Key inclusion criteria
Key

* Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria for RA), 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 screening and Day 1
* Ongoing treatment with a stable prescription of 1 or 2 csDMARDs
* Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for the treatment of RA to which they have had an inadequate response or intolerance

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 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
27/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/06/2018
Sample size
Target
Accrual to date
Final
449
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
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Hampshire
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Caba
Country [26] 0 0
Argentina
State/province [26] 0 0
San Juan
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Merksem
Country [30] 0 0
France
State/province [30] 0 0
Montpellier
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Germany
State/province [33] 0 0
Ratingen
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Gyula
Country [36] 0 0
Hungary
State/province [36] 0 0
Székesfehérvár
Country [37] 0 0
Israel
State/province [37] 0 0
Haifa
Country [38] 0 0
Israel
State/province [38] 0 0
Ramat Gan
Country [39] 0 0
Japan
State/province [39] 0 0
Hiroshima
Country [40] 0 0
Japan
State/province [40] 0 0
Izumo
Country [41] 0 0
Japan
State/province [41] 0 0
Kato
Country [42] 0 0
Japan
State/province [42] 0 0
Kawagoe
Country [43] 0 0
Japan
State/province [43] 0 0
Kumamoto
Country [44] 0 0
Japan
State/province [44] 0 0
Narashino
Country [45] 0 0
Japan
State/province [45] 0 0
Okayama
Country [46] 0 0
Japan
State/province [46] 0 0
Sagamihara
Country [47] 0 0
Japan
State/province [47] 0 0
Sapporo
Country [48] 0 0
Japan
State/province [48] 0 0
Shinjuku-Ku
Country [49] 0 0
Japan
State/province [49] 0 0
Takaoka
Country [50] 0 0
Japan
State/province [50] 0 0
Takasaki
Country [51] 0 0
Japan
State/province [51] 0 0
Tokorozawa
Country [52] 0 0
Japan
State/province [52] 0 0
Tokyo
Country [53] 0 0
Japan
State/province [53] 0 0
Tomigusuku
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul
Country [55] 0 0
Mexico
State/province [55] 0 0
Chihuahua
Country [56] 0 0
Mexico
State/province [56] 0 0
Distrito Federal
Country [57] 0 0
Mexico
State/province [57] 0 0
Mérida
Country [58] 0 0
Poland
State/province [58] 0 0
Bialystok
Country [59] 0 0
Poland
State/province [59] 0 0
Poznan
Country [60] 0 0
Poland
State/province [60] 0 0
Warszawa
Country [61] 0 0
Poland
State/province [61] 0 0
Wroclaw
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Málaga
Country [64] 0 0
Spain
State/province [64] 0 0
Sabadell
Country [65] 0 0
Spain
State/province [65] 0 0
Valencia
Country [66] 0 0
Switzerland
State/province [66] 0 0
Sankt Gallen
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Doncaster
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Edinburgh
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Goodmayes
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Harlow
Country [71] 0 0
United Kingdom
State/province [71] 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



Results are available at https://clinicaltrials.gov/study/NCT02873936