Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02886728
• Date of registration: 29/08/2016
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy FINCH 3
• 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 Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy
• Date of first enrolment: August 8, 2016
• Target sample size: 1252
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02886728
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czech Republic, Czechia, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Have a diagnosis of RA (2010 ACR/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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Filgotinib

Drug: Placebo to match filgotinib

Drug: MTX

Drug: Placebo to match MTX

Primary Outcome(s)

Proportion of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

Proportion of Participants who Achieve ACR20 at Weeks 4, 12, and 52 [Time Frame: Weeks 4, 12, and 52]

Proportion of Participants with no Radiographic Progression from Baseline at Week 24 and 52 [Time Frame: Baseline; Weeks 24 and 52]

Change from Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, 24, and 52, and Over Time from Day 1 through Week 52 [Time Frame: Baseline and up to 52 weeks]

Proportion of Participants who Achieve ACR20 Over Time from Day 1 through Week 52 [Time Frame: Up to 52 weeks]

Proportion of Participants who Achieve ACR50 Over Time from Day 1 through Week 52 [Time Frame: Up to 52 weeks]

Change from Baseline in Simplified Diagnostic Activity Index (SDAI) at Weeks 4, 12, 24, and 52, and Over Time from Day 1 through Week 52 [Time Frame: Baseline and up to 52 weeks]

Proportion of Participants who Achieve DAS28 (CRP) < 2.6 at Weeks 4, 12, and 52, and Over Time from Day 1 through Week 52 [Time Frame: Up to 52 weeks]

Absolute Value and Change from Baseline in the EuroQol 5 Dimensions (EQ-5D) Patient-Reported Outcomes Survey at Weeks 4, 12, 24 and 52, and Over Time from Day 1 through Week 52 [Time Frame: Baseline and up to 52 weeks]

Change from Baseline in DAS28 (CRP) at Weeks 4, 12, 24, and 52, and Over Time from Day 1 through Week 52 [Time Frame: Baseline and up to 52 weeks]

Proportion of Participants who Achieve ACR 50% Improvement (ACR50) at Weeks 4, 12, 24, and 52 [Time Frame: Weeks 4, 12, 24, and 52]

Proportion of Participants who Achieve DAS28 (CRP) = 3.2 at Weeks 4, 12, 24, and 52, and Over Time from Day 1 through Week 52 [Time Frame: Up to 52 weeks]

Proportion of Participants who Achieve Disease Activity Score based on 28 joints (DAS28) (C-reactive protein (CRP)) < 2.6 at Week 24 [Time Frame: Week 24]

Absolute Value and Change from Baseline in Short-form Health Survey (SF-36) at Weeks 4, 12, 24 and 52, and Over Time from Day 1 through Week 52 [Time Frame: Baseline and up to 52 weeks]

American College of Rheumatology N (ACR-N) at Weeks 4, 12, 24, and 52, and Over Time from Day 1 through Week 52 [Time Frame: Up to 52 weeks]

Change from Baseline in the Modified Total Sharp Score (mTSS) at Weeks 24 and 52 [Time Frame: Baseline; Weeks 24 and 52]

European League Against Rheumatism (EULAR) Response at Weeks 4, 12, 24, and 52, and Over Time from Day 1 through Week 52 [Time Frame: Up to 52 weeks]

Proportion of Participants who Achieve ACR 70% Improvement (ACR70) at Weeks 4, 12, 24, and 52 [Time Frame: Weeks 4, 12, 24, and 52]

Proportion of Participants who Achieve Change in HAQ-DI of = 0.22 at Weeks 4, 12, 24, and 52, and Over Time from Day 1 through Week 52 [Time Frame: Up to 52 weeks]

Absolute Value and Change from Baseline in Work Productivity and Activity Impairment - Rheumatoid Arthritis (WPAI-RA) Patient-Reported Outcomes Survey at Weeks 4, 12, 24, and 52, and Over Time from Day 1 through Week 52 [Time Frame: Baseline and up to 52 weeks]

Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24 [Time Frame: Week 24]

Proportion of Participants who Achieve ACR70 Over Time from Day 1 through Week 52 [Time Frame: Up to 52 weeks]

Absolute Value and Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at Weeks 4, 12, 24 and 52, and Over Time from Day 1 through Week 52 [Time Frame: Baseline and up to 52 weeks]

Change from Baseline in Individual Components of the ACR Response at Weeks 4, 12, 24, and 52 and Over Time from Day 1 through Week 52 [Time Frame: Baseline and up to 52 weeks]

Secondary ID(s)

2016-000570-37

GS-US-417-0303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Galapagos NV