Clinical trial NCT02873936: 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2016-08-22
Enrollment: 449
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 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 Exclusion Criteria:

* Previous treatment with any janus kinase (JAK) inhibitor

NOTE: Other protocol 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)] ≤ 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: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24
timeFrame: Week 24
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 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24
timeFrame: Weeks 4, and 24
measure: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24
timeFrame: Baseline; Weeks 4, and 24
measure: Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24
timeFrame: Weeks 4, and 24
measure: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12
timeFrame: Weeks 4, and 12
measure: American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: SF-36 PCS Score at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
timeFrame: Baseline; Weeks 4, and 24
measure: SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
measure: FACIT-Fatigue Score at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
timeFrame: Baseline; Weeks 4, and 24
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: EQ-5D Current Health VAS at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
measure: Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
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 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 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 Activity Impairment Due to RA at Weeks 4, 12, and 24
timeFrame: Weeks 4, 12, and 24
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 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 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 Activity Impairment Due to RA at Weeks 4, 12, and 24
timeFrame: Baseline; Weeks 4, 12, and 24
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Gilbert
country: United States
state: Arizona
city: Covina
country: United States
state: California
city: Hemet
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Palm Desert
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Riverside
country: United States
state: California
city: Upland
country: United States
state: California
city: Victorville
country: United States
state: California
city: Whittier
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: DeBary
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Port Richey
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Kansas City
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Elizabethtown
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Cumberland
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Saint Clair Shores
country: United States
state: Michigan
city: Hattiesburg
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Freehold
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Middleburg Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Beaumont
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Mesquite
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Webster
country: United States
state: Texas
city: Buenos Aires
country: Argentina
city: Caba
country: Argentina
city: San Juan
country: Argentina
city: Victoria Park
country: Australia
state: Western Australia
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Merksem
country: Belgium
city: Montpellier
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Ratingen
country: Germany
city: Budapest
country: Hungary
city: Gyula
country: Hungary
city: Székesfehérvár
country: Hungary
city: Haifa
country: Israel
city: Ramat Gan
country: Israel
city: Hiroshima
country: Japan
city: Izumo
country: Japan
city: Katō
country: Japan
city: Kawagoe
country: Japan
city: Kumamoto
country: Japan
city: Narashino
country: Japan
city: Okayama
country: Japan
city: Sagamihara
country: Japan
city: Sapporo
country: Japan
city: Shinjuku-Ku
country: Japan
city: Takaoka
country: Japan
city: Takasaki
country: Japan
city: Tokorozawa
country: Japan
city: Tokyo
country: Japan
city: Tomigusuku
country: Japan
city: Seoul
country: Korea, Republic of
city: Chihuahua
country: Mexico
city: Distrito Federal
country: Mexico
city: Mérida
country: Mexico
city: Białystok
country: Poland
city: Poznań
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Sabadell
country: Spain
city: Valencia
country: Spain
city: Sankt Gallen
country: Switzerland
city: Doncaster
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Goodmayes
country: United Kingdom
city: Harlow
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Genovese MC, Kalunian KC, Walker D, Gottenberg JE, De Vlam K, Mozaffarian N, et al. Safety and Efficacy of Filgotinib in a Phase 3 Trial of Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic Dmards [Abstract No. L06]. ACR/ARHP Annual Meeting; 2018 19-24 October; Chicago, IL, USA.
citation: Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, Gao J, Guo Y, Tasset C, Sundy JS, de Vlam K, Walker D, Takeuchi T. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):315-325. doi: 10.1001/jama.2019.9055.
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: Takeuchi T, Matsubara T, Atsumi T, Amano K, Ishiguro N, Sugiyama E, Yamaoka K, Genovese MC, Kalunian K, Walker D, Gottenberg JE, de Vlam K, Bartok B, Pechonkina A, Kondo A, Gao J, Guo Y, Tasset C, Sundy JS, Tanaka Y. Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global phase 3 study (FINCH 2). Mod Rheumatol. 2022 Jan 5;32(1):59-67. doi: 10.1080/14397595.2020.1859675.