Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (FINCH 1)
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ClinicalTrials.gov Identifier: NCT02889796 |
Recruitment Status :
Completed
First Posted : September 7, 2016
Results First Posted : January 19, 2021
Last Update Posted : June 9, 2021
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Sponsor:
Gilead Sciences
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Rheumatoid Arthritis |
Interventions |
Drug: Filgotinib Drug: Placebo to match filgotinib Drug: Adalimumab Drug: Placebo to match adalimumab Drug: MTX |
Enrollment | 1759 |
Participant Flow
Recruitment Details | Participants were enrolled at study sites in Asia, South Africa, Australia, Europe, North America, South America, and New Zealand. The first participant was screened on 30 August 2016. The last study visit occurred on 20 June 2019. |
Pre-assignment Details | 2582 participants were screened. |
Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Adalimumab | Placebo to Filgotinib 200 mg | Placebo to Filgotinib 100 mg | Placebo Never Received Filgotinib |
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Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks. | Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks. | Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks. | Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks. | Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks. | Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. |
Period Title: Overall Study | ||||||
Started | 477 | 480 | 325 | 190 | 191 | 96 |
Completed | 424 | 422 | 281 | 181 | 185 | 24 [1] |
Not Completed | 53 | 58 | 44 | 9 | 6 | 72 |
Reason Not Completed | ||||||
Withdrew Consent | 18 | 29 | 20 | 1 | 2 | 35 |
Investigator's Discretion | 10 | 9 | 10 | 3 | 0 | 15 |
Adverse Event | 17 | 8 | 8 | 4 | 1 | 7 |
Lost to Follow-up | 5 | 7 | 2 | 0 | 2 | 6 |
Protocol Violation | 0 | 1 | 3 | 0 | 0 | 4 |
Non-compliance With Study Drug | 0 | 2 | 0 | 0 | 1 | 2 |
Death | 1 | 1 | 0 | 1 | 0 | 1 |
Pregnancy | 0 | 1 | 1 | 0 | 0 | 0 |
Randomized but not Dosed | 2 | 0 | 0 | 0 | 0 | 2 |
[1]
Completed 24 weeks of placebo treatment and not rerandomized to Filgotinib 200 mg or 100 mg groups
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Baseline Characteristics
Arm/Group Title | Filgotinib 200 mg | Filgotinib 100 mg | Adalimumab | Placebo | Total | |
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Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks. | Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks. | Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks. | The Placebo arm includes all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups. | Total of all reporting groups | |
Overall Number of Baseline Participants | 475 | 480 | 325 | 475 | 1755 | |
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The Safety Analysis Set included all participants who received at least 1 dose of study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 475 participants | 480 participants | 325 participants | 475 participants | 1755 participants | |
52 (12.8) | 53 (12.6) | 53 (12.9) | 53 (12.8) | 53 (12.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 475 participants | 480 participants | 325 participants | 475 participants | 1755 participants | |
Female | 379 | 399 | 266 | 391 | 1435 | |
Male | 96 | 81 | 59 | 84 | 320 | |
Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 475 participants | 480 participants | 325 participants | 475 participants | 1755 participants |
American Indian or Alaska Native | 27 | 27 | 20 | 29 | 103 | |
Asian: Japanese | 40 | 41 | 28 | 38 | 147 | |
Asian: Chinese/Taiwanese/Hong Kong Chinese | 13 | 12 | 8 | 18 | 51 | |
Asian: Korean | 13 | 10 | 4 | 7 | 34 | |
Asian: Other | 56 | 52 | 25 | 46 | 179 | |
Black or African American | 6 | 7 | 10 | 12 | 35 | |
Native Hawaiian or Pacific Islander | 1 | 0 | 0 | 2 | 3 | |
White | 312 | 324 | 229 | 319 | 1184 | |
Other | 7 | 6 | 1 | 3 | 17 | |
Not Permitted | 0 | 1 | 0 | 1 | 2 | |
[1]
Measure Description: Not Permitted=local regulators did not allow collection of race information.
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Ethnicity | Number Analyzed | 475 participants | 480 participants | 325 participants | 475 participants | 1755 participants |
Hispanic or Latino | 67 | 71 | 54 | 70 | 262 | |
Not Hispanic or Latino | 404 | 399 | 268 | 400 | 1471 | |
Not Permitted | 4 | 10 | 3 | 5 | 22 | |
[1]
Measure Description: Not Permitted=local regulators did not allow collection of ethnicity information.
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 475 participants | 480 participants | 325 participants | 475 participants | 1755 participants |
United States | 47 | 55 | 37 | 60 | 199 | |
South Africa | 12 | 11 | 3 | 8 | 34 | |
South Korea | 12 | 10 | 4 | 7 | 33 | |
Spain | 14 | 3 | 6 | 7 | 30 | |
Germany | 5 | 6 | 5 | 4 | 20 | |
New Zealand | 5 | 5 | 3 | 5 | 18 | |
United Kingdom | 1 | 2 | 4 | 6 | 13 | |
Canada | 4 | 4 | 3 | 1 | 12 | |
Israel | 4 | 1 | 2 | 4 | 11 | |
Belgium | 2 | 3 | 4 | 1 | 10 | |
Italy | 2 | 1 | 2 | 1 | 6 | |
Netherlands | 0 | 1 | 0 | 1 | 2 | |
Australia | 0 | 1 | 0 | 0 | 1 | |
Ireland | 0 | 1 | 0 | 0 | 1 | |
Poland | 78 | 82 | 64 | 74 | 298 | |
Ukraine | 66 | 73 | 41 | 55 | 235 | |
India | 40 | 39 | 19 | 39 | 137 | |
Russia | 34 | 32 | 22 | 30 | 118 | |
Hungary | 12 | 12 | 5 | 17 | 46 | |
Bulgaria | 7 | 7 | 6 | 14 | 34 | |
Czechia | 7 | 7 | 7 | 13 | 34 | |
Romania | 12 | 6 | 2 | 11 | 31 | |
Serbia | 1 | 7 | 8 | 5 | 21 | |
Slovakia | 2 | 2 | 1 | 3 | 8 | |
Mexico | 33 | 33 | 25 | 34 | 125 | |
Argentina | 15 | 17 | 10 | 15 | 57 | |
Taiwan | 12 | 9 | 7 | 16 | 44 | |
Thailand | 7 | 6 | 6 | 4 | 23 | |
Hong Kong | 1 | 3 | 1 | 2 | 7 | |
Japan | 40 | 41 | 28 | 38 | 147 |