Clinical trial NCT02886728: Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2016-09-01
Enrollment: 1252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).


Eligibility criteria: Key Inclusion Criteria:

* 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 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24
timeFrame: Week 24
measure: Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in the mTSS at Week 52
timeFrame: Baseline; Week 52
measure: Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52
timeFrame: Weeks 2, 4, 12, 36, and 52
measure: Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Weeks 2, 4, 12, 24, 36, and 52
measure: Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Weeks 2, 4, 12, 24, 36, and 52
measure: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 36, and 52
measure: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
measure: Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
measure: Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
measure: Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
measure: Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
measure: Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
measure: Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Weeks 2, 4, 12, 24, 36, and 52
measure: Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
measure: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52
timeFrame: Weeks 4, 12, 24, and 52
measure: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52
timeFrame: Weeks 2, 4, 12, 36, and 52
measure: ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Weeks 2, 4, 12, 24, 36, and 52
measure: Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Weeks 2, 4, 12, 24, 36, and 52
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 2, 4, 12, 24, 36, and 52
measure: Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52
timeFrame: Baseline; Weeks 24, and 52
measure: SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52
timeFrame: Baseline; Weeks 4, 12, 36, and 52
measure: SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 4, 12, 24, 36, and 52
measure: FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52
timeFrame: Baseline; Weeks 4, 12, 36, and 52
measure: Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 4, 12, 24, 36, and 52
measure: Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52
measure: Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 4, 12, 24, 36, and 52
measure: Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 4, 12, 24, 36, and 52
measure: Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 4, 12, 24, 36, and 52
measure: Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52
timeFrame: Baseline; Weeks 4, 12, 24, 36, and 52
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Phoenix
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state: Arizona
city: Tucson
country: United States
state: Arizona
city: Covina
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state: California
city: Los Angeles
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state: California
city: Palm Desert
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state: California
city: Victorville
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state: California
city: Whittier
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state: California
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state: Florida
city: Jacksonville
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state: Florida
city: Miami
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city: Orlando
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city: Plantation
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state: Illinois
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state: Kentucky
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state: Maryland
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state: Maryland
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city: Saint Clair Shores
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state: Michigan
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state: Minnesota
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state: Mississippi
city: Tupelo
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state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Lincoln
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state: Nebraska
city: Lebanon
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state: New Hampshire
city: Freehold
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Charlotte
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Bethlehem
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Charleston
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state: South Carolina
city: Orangeburg
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state: South Carolina
city: Memphis
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state: Tennessee
city: Beaumont
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state: Texas
city: Carrollton
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state: Texas
city: Corpus Christi
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state: Texas
city: Mesquite
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state: Texas
city: Plano
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state: Texas
city: San Antonio
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state: Texas
city: Webster
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state: Texas
city: Buenos Aires
country: Argentina
city: Caba
country: Argentina
city: Mendoza
country: Argentina
city: Quilmes
country: Argentina
city: San Fernando
country: Argentina
city: San Juan
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city: San Miguel de Tucumán
country: Argentina
city: Maroochydore
country: Australia
state: Queensland
city: Hobart
country: Australia
state: Tasmania
city: Victoria Park
country: Australia
state: Western Australia
city: Leuven
country: Belgium
state: Flemish Brabant
city: Genk
country: Belgium
city: Hasselt
country: Belgium
city: Merksem
country: Belgium
city: Dobrich
country: Bulgaria
city: Haskovo
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Vidin
country: Bulgaria
city: Barrie
country: Canada
state: Ontario
city: Trois-Rivieres
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Temuco
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city: Ostrava
country: Czechia
city: Prague 2
country: Czechia
city: Praha 4
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Aachen
country: Germany
city: Hamburg
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city: Ratingen
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city: Hong Kong
country: Hong Kong
city: Tuen Mun
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city: Kalocsa
country: Hungary
state: Bacs-Kiskun
city: Székesfehérvár
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state: Fejer
city: Budapest
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city: Kistarcsa
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city: Ahmedabad
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city: Bangalore
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city: Delhi
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city: Jaipur
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city: Lucknow
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city: Srikakulam
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city: Visakhapatnam
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city: Dublin 4
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city: Fukuoka
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city: Hamamatsu
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city: Hiroshima
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city: Kagoshima
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city: Katō
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city: Kawagoe
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city: Miyagi
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city: Nagaoka
country: Japan
city: Nagasaki
country: Japan
city: Okayama
country: Japan
city: Sanuki
country: Japan
city: Sapporo
country: Japan
city: Sasebo
country: Japan
city: Sayama
country: Japan
city: Tokyo
country: Japan
city: Ōme
country: Japan
city: Anyang-si
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
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city: Batu Caves
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Mérida
country: Mexico
state: Yucatan
city: Chihuahua
country: Mexico
city: Distrito Federal
country: Mexico
city: Monterrey
country: Mexico
city: Morelia
country: Mexico
city: Mérida
country: Mexico
city: Timaru
country: New Zealand
state: Canterbury
city: Hamilton
country: New Zealand
city: Newtown
country: New Zealand
city: Papatoetoe
country: New Zealand
city: Białystok
country: Poland
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Dąbrówka
country: Poland
city: Elbląg
country: Poland
city: Gdynia
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Nowa Sól
country: Poland
city: Poznan
country: Poland
city: Toruń
country: Poland
city: Warszawa
country: Poland
city: Targu Mures
country: Romania
state: Mures
city: Bucharest
country: Romania
city: Oradea
country: Romania
city: Barnaul
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Saratov
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Bratislava
country: Slovakia
city: Prievidza
country: Slovakia
city: Topol'cany
country: Slovakia
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Sabadell
country: Spain
state: Barcelona
city: Barakaldo
country: Spain
city: La Coruña
country: Spain
city: Málaga
country: Spain
city: Sabadell
country: Spain
city: Santiago de Compostela
country: Spain
city: Valencia
country: Spain
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Songkhla
country: Thailand
city: Dnipro
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kyiv
country: Ukraine
city: L'viv
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Edinburgh
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Westhovens R, Rigby W, van der Heijde D, Ching D, Bartok B, Matzkies F, et al. Efficacy and safety of filgotinib for patients with rheumatoid arthritis naive to methotrexate therapy: FINCH 3 primary outcome results. Ann Rheum Dis 2019; 78 (supplement 2): A259.
citation: 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.
citation: 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.
citation: 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.
citation: Aletaha D, Westhovens R, Gaujoux-Viala C, Adami G, Matsumoto A, Bird P, Messina OD, Buch MH, Bartok B, Yin Z, Guo Y, Hendrikx T, Burmester GR. Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3. RMD Open. 2021 Aug;7(2):e001621. doi: 10.1136/rmdopen-2021-001621.
citation: Westhovens R, Rigby WFC, van der Heijde D, Ching DWT, Stohl W, Kay J, Chopra A, Bartok B, Matzkies F, Yin Z, Guo Y, Tasset C, Sundy JS, Jahreis A, Mozaffarian N, Messina OD, Landewe RB, Atsumi T, Burmester GR. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. 2021 Jun;80(6):727-738. doi: 10.1136/annrheumdis-2020-219213. Epub 2021 Jan 15.