Clinical trial NCT02889796: Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
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 in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2016-09-07
Enrollment: 1759
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 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.


Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* Previous treatment with any janus kinase (JAK) inhibitor

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 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
timeFrame: Baseline; Week 12
measure: Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12
timeFrame: Week 12
measure: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12
timeFrame: Week 12
measure: Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
timeFrame: Baseline; Week 12
measure: Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24
timeFrame: Weeks 2, 4, 12, and 24
measure: Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24
timeFrame: Weeks 2, 4, 12, and 24
measure: Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24
timeFrame: Weeks 2, 4, and 24
measure: Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24
timeFrame: Baseline; Weeks 2, 4, and 24
measure: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24
timeFrame: Baseline; Weeks 2, 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24
timeFrame: Baseline; Weeks 2, 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24
timeFrame: Baseline; Weeks 2, 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24
timeFrame: Baseline; Weeks 2, 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24
timeFrame: Baseline; Weeks 2, 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24
timeFrame: Baseline; Weeks 2, 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24
timeFrame: Weeks 2, 4, 12, and 24
measure: Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24
timeFrame: Baseline; Weeks 2, 4, 12, and 24
measure: Change From Baseline in DAS28 (CRP) at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24
timeFrame: Weeks 2, 4, and 24
measure: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24
timeFrame: Weeks 2, 4, and 24
measure: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24
timeFrame: Weeks 2, 4, 12, and 24
measure: ACR N Percent Improvement (ACR-N) at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24
timeFrame: Weeks 2, 4, 12, and 24
measure: Number of Participants With EULAR Response at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24
timeFrame: Baseline; Weeks 2, 4, 12, and 24
measure: Change From Baseline in CDAI at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24
timeFrame: Baseline; Weeks 2, 4, 12, and 24
measure: Change From Baseline in SDAI at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in mTSS at Week 52
timeFrame: Baseline; Week 52
measure: Percentage of Participants With no Radiographic Progression From Baseline at Week 24
timeFrame: Baseline; Weeks 24
measure: Percentage of Participants With no Radiographic Progression From Baseline at Week 52
timeFrame: Baseline; Week 52
measure: 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: SF-36 PCS Score at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
timeFrame: Baseline; Weeks 4, and 24
measure: Change From Baseline in SF-36 PCS Score at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: SF-36 MCS Score at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in SF-36 MCS Score at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: FACIT-Fatigue Score at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
timeFrame: Baseline; Weeks 4, and 24
measure: Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: EQ-5D Current Health VAS at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: EQ-5D Current Health VAS at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
timeFrame: Weeks 36, and 52
measure: Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
measure: Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
timeFrame: Baseline; Weeks 36, and 52
Other outcomes:
Locations:
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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: Hemet
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state: California
city: La Jolla
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state: California
city: Palm Desert
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state: California
city: Upland
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state: California
city: Victorville
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state: California
city: Whittier
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state: California
city: Clearwater
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state: Florida
city: DeBary
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state: Florida
city: Jacksonville
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state: Florida
city: Miami Lakes
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state: Florida
city: Miami
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state: Florida
city: New Port Richey
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state: Florida
city: Orlando
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state: Florida
city: Plantation
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state: Florida
city: Kansas City
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state: Kansas
city: Wichita
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state: Kansas
city: Elizabethtown
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state: Kentucky
city: Lexington
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state: Kentucky
city: Cumberland
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Saint Clair Shores
country: United States
state: Michigan
city: Eagan
country: United States
state: Minnesota
city: Hattiesburg
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Toms River
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Salisbury
country: United States
state: North Carolina
city: Bethlehem
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wyomissing
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state: Pennsylvania
city: Charleston
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state: South Carolina
city: Columbia
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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
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
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state: Texas
city: Mesquite
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Webster
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state: Texas
city: Buenos Aires
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city: Caba
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city: Mendoza
country: Argentina
city: Quilmes
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city: San Fernando
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city: New Delhi
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city: Secunderabad
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city: Srikakulam
country: India
city: Surat
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city: Vadodara
country: India
city: Visakhapatnam
country: India
city: Dublin 4
country: Ireland
city: Haifa
country: Israel
city: Tel Aviv
country: Israel
city: Tel-Hashomer
country: Israel
city: Bologna
country: Italy
city: Catania
country: Italy
city: Milano
country: Italy
city: Chiba-shi
country: Japan
city: Fukuoka
country: Japan
city: Hiroshima
country: Japan
city: Iizuka-shi
country: Japan
city: Iruma-gun
country: Japan
city: Izumo
country: Japan
city: Kagoshima-shi
country: Japan
city: Katō
country: Japan
city: Kitakyushu-shi
country: Japan
city: Kobe
country: Japan
city: Kumamoto
country: Japan
city: Kurume-shi
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city: Kyoto-shi
country: Japan
city: Kyoto
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city: Miyazaki
country: Japan
city: Morioka
country: Japan
city: Nagaoka
country: Japan
city: Nagasaki-shi
country: Japan
city: Nagasaki
country: Japan
city: Nagoya
country: Japan
city: Narashino
country: Japan
city: Nishinomiya
country: Japan
city: Sanuki-shi
country: Japan
city: Sapporo
country: Japan
city: Sasebo-shi
country: Japan
city: Sayama-shi
country: Japan
city: Shibata-City
country: Japan
city: Shinjuku-Ku
country: Japan
city: Shizuoka
country: Japan
city: Suita-shi
country: Japan
city: Takaoka
country: Japan
city: Takasaki-shi
country: Japan
city: Tokorozawa
country: Japan
city: Tokyo
country: Japan
city: Tsukuba-shi
country: Japan
city: Wakayama
country: Japan
city: Yokohama-shi
country: Japan
city: Ōita
country: Japan
city: Anyang-si
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Mérida
country: Mexico
state: Yucatan
city: Chihuahua
country: Mexico
city: Ciudad de Mexico
country: Mexico
city: Distrito Federal
country: Mexico
city: Monterrey
country: Mexico
city: Morelia
country: Mexico
city: Mérida
country: Mexico
city: Leiden
country: Netherlands
city: Papatoetoe
country: New Zealand
state: Auckland
city: Auckland
country: New Zealand
city: Hamilton
country: New Zealand
city: Newtown
country: New Zealand
city: Timaru
country: New Zealand
city: Wroclaw
country: Poland
state: Dolnoslaskie
city: Białystok
country: Poland
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Elbląg
country: Poland
city: Gdynia
country: Poland
city: Kartuzy
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Nowa Sól
country: Poland
city: Poznan
country: Poland
city: Poznań
country: Poland
city: Tomaszów Lubelski
country: Poland
city: Toruń
country: Poland
city: Warsaw
country: Poland
city: Warszawa
country: Poland
city: Oradea
country: Romania
state: Bihor
city: Bucharest
country: Romania
state: Bucuresti
city: Bacau
country: Romania
city: Târgu-Mureş
country: Romania
city: Barnaul
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: Vladimir
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Niška Banja
country: Serbia
city: Bratislava
country: Slovakia
city: Prievidza
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Topol'cany
country: Slovakia
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: La Coruna
country: Spain
city: Málaga
country: Spain
city: Sabadell
country: Spain
city: Santiago de Compostela
country: Spain
city: Valencia
country: Spain
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Keelung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Chiangmai
country: Thailand
city: Songkla
country: Thailand
city: Dnipro
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: L'viv
country: Ukraine
city: Luts'k
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Poole
country: United Kingdom
state: England
city: Doncaster
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Warrington
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
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: 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.