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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)

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ClinicalTrials.gov Identifier: NCT02886728
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Filgotinib Drug: Placebo to match filgotinib Drug: MTX Drug: Placebo to match MTX Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy
Actual Study Start Date : August 8, 2016
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : May 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Filgotinib Dose A + MTX
Filgotinib dose A + placebo to match filgotinib dose B + MTX
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Name: GS-6034

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Drug: MTX
Capsule(s) administered orally once weekly

Experimental: Filgotinib Dose B + MTX
Filgotinib dose B + placebo to match filgotinib dose A + MTX
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Name: GS-6034

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Drug: MTX
Capsule(s) administered orally once weekly

Experimental: Filgotinib Dose A
Filgotinib dose A + placebo to match filgotinib dose B + placebo to match MTX
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Name: GS-6034

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Drug: Placebo to match MTX
Capsule(s) administered orally once weekly

Active Comparator: MTX
Placebo to match filgotinib dose A + placebo to match filgotinib dose B + MTX
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Drug: MTX
Capsule(s) administered orally once weekly




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

Secondary Outcome Measures :
  1. Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24 [ Time Frame: Week 24 ]
  2. 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 ]
  3. Change from Baseline in the Modified Total Sharp Score (mTSS) at Weeks 24 and 52 [ Time Frame: Baseline; Weeks 24 and 52 ]
  4. Proportion of Participants who Achieve ACR 50% Improvement (ACR50) at Weeks 4, 12, 24, and 52 [ Time Frame: Weeks 4, 12, 24, and 52 ]
  5. Proportion of Participants who Achieve ACR 70% Improvement (ACR70) at Weeks 4, 12, 24, and 52 [ Time Frame: Weeks 4, 12, 24, and 52 ]
  6. Proportion of Participants who Achieve ACR20 at Weeks 4, 12, and 52 [ Time Frame: Weeks 4, 12, and 52 ]
  7. Proportion of Participants who Achieve ACR20 Over Time from Day 1 through Week 52 [ Time Frame: Up to 52 weeks ]
  8. Proportion of Participants who Achieve ACR50 Over Time from Day 1 through Week 52 [ Time Frame: Up to 52 weeks ]
  9. Proportion of Participants who Achieve ACR70 Over Time from Day 1 through Week 52 [ Time Frame: Up to 52 weeks ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 ]
  19. Proportion of Participants with no Radiographic Progression from Baseline at Week 24 and 52 [ Time Frame: Baseline; Weeks 24 and 52 ]
  20. 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 ]
  21. 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 ]
  22. 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 ]
  23. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886728


  Show 187 Study Locations
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02886728     History of Changes
Other Study ID Numbers: GS-US-417-0303
2016-000570-37 ( EudraCT Number )
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors