Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02889796 |
Date of registration:
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31/08/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
FINCH 1 |
Scientific title:
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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 |
Date of first enrolment:
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August 30, 2016 |
Target sample size:
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1759 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02889796 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Bulgaria
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Canada
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Czech Republic
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Czechia
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France
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Germany
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Hong Kong
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Hungary
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India
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Ireland
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Israel
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Italy
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Japan
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Korea, Republic of
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Mexico
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Netherlands
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New Zealand
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Poland
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Romania
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Russian Federation
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Serbia
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Slovakia
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South Africa
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Spain
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Taiwan
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Thailand
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Gilead Study Director |
Address:
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Telephone:
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Email:
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Affiliation:
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Gilead Sciences |
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Key inclusion & exclusion criteria
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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.
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Placebo to match filgotinib
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Drug: Filgotinib
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Drug: Placebo to match adalimumab
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Drug: Adalimumab
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Drug: MTX
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Primary Outcome(s)
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Proportion of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
[Time Frame: Week 12]
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Secondary Outcome(s)
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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]
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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]
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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]
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Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
[Time Frame: Week 12]
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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]
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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]
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Change from Baseline in Simplified Diagnostic Activity Index (SDAI) at Weeks 4, 12, 24, and 52, and Over Time from Day 1 through Week 24
[Time Frame: Baseline and up to 24 weeks]
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Proportion of Participants who Achieve ACR20 at Weeks 4, 24, and 52
[Time Frame: Weeks 4, 24, and 52]
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Proportion of Participants who Achieve Disease Activity Score based on 28 joints (DAS28) (C-reactive protein (CRP)) = 3.2 at Week 12
[Time Frame: Week 12]
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Proportion of Participants who Achieve ACR50 Over Time from Day 1 through Week 52
[Time Frame: Up to 52 weeks]
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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]
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Proportion of Participants who Achieve ACR 70% Improvement (ACR70) at Weeks 4, 12, 24, and 52
[Time Frame: Weeks 4, 12, 24, and 52]
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Change from Baseline in the mTSS at Week 52
[Time Frame: Baseline; Week 52]
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Proportion of Participants who Achieve ACR 50% Improvement (ACR50) at Weeks 4, 12, 24, and 52
[Time Frame: Weeks 4, 12, 24, and 52]
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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]
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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]
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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]
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Proportion of Participants who Achieve DAS28 (CRP) = 3.2 at Weeks 4, 24, and 52, and Over Time from Day 1 through Week 52
[Time Frame: Up to 52 weeks]
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Proportion of Participants with No Radiographic Progression from Baseline at Weeks 24 and 52
[Time Frame: Baseline; Weeks 24 and 52]
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Proportion of Participants who Achieve DAS28 (CRP) < 2.6 at Week 24
[Time Frame: Week 24]
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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]
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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]
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Change from Baseline in the Modified Total Sharp Score (mTSS) at Week 24
[Time Frame: Week 24]
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Proportion of Participants who Achieve ACR70 Over Time from Day 1 through Week 52
[Time Frame: Up to 52 weeks]
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Proportion of Participants who Achieve ACR20 Over Time from Day 1 through Week 52
[Time Frame: Up to 52 weeks]
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Secondary ID(s)
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2016-000568-41
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GS-US-417-0301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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