Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (FINCH 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02889796
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : July 9, 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 versus placebo in adults with active rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1759 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 in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Actual Study Start Date : August 30, 2016
Actual Primary Completion Date : July 4, 2018
Actual Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Filgotinib Dose A
Filgotinib dose A + placebo to match filgotinib dose B + placebo to match adalimumab in addition to a stable dose of 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 adalimumab
Administered via subcutaneous injection once every two weeks

Drug: MTX
Commercially sourced tablet(s) administered orally

Experimental: Filgotinib Dose B
Filgotinib dose B + placebo to match filgotinib dose A + placebo to match adalimumab in addition to a stable dose of 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 adalimumab
Administered via subcutaneous injection once every two weeks

Drug: MTX
Commercially sourced tablet(s) administered orally

Active Comparator: Adalimumab
Placebo to match filgotinib dose A + placebo to match filgotinib dose B + adalimumab in addition to a stable dose of MTX
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Drug: Adalimumab
40 mg/mL administered via subcutaneous injection once every two weeks

Drug: MTX
Commercially sourced tablet(s) administered orally

Placebo Comparator: Placebo
Placebo to match filgotinib dose A + placebo to match filgotinib dose B + placebo to match adalimumab in addition to a stable dose of MTX
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Drug: Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks

Drug: MTX
Commercially sourced tablet(s) administered orally




Primary Outcome Measures :
  1. Proportion of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 [ Time Frame: Week 12 ]
  3. Proportion of Participants who Achieve DAS28 (CRP) < 2.6 at Week 24 [ Time Frame: Week 24 ]
  4. Change from Baseline in the Modified Total Sharp Score (mTSS) at Week 24 [ Time Frame: Week 24 ]
  5. Proportion of Participants who Achieve ACR 50% Improvement (ACR50) at Weeks 4, 12, 24, and 52 [ Time Frame: Weeks 4, 12, 24, and 52 ]
  6. Proportion of Participants who Achieve ACR 70% Improvement (ACR70) at Weeks 4, 12, 24, and 52 [ Time Frame: Weeks 4, 12, 24, and 52 ]
  7. Proportion of Participants who Achieve ACR20 at Weeks 4, 24, and 52 [ Time Frame: Weeks 4, 24, and 52 ]
  8. Proportion of Participants who Achieve ACR20 Over Time from Day 1 through Week 52 [ Time Frame: Up to 52 weeks ]
  9. Proportion of Participants who Achieve ACR50 Over Time from Day 1 through Week 52 [ Time Frame: Up to 52 weeks ]
  10. Proportion of Participants who Achieve ACR70 Over Time from Day 1 through Week 52 [ Time Frame: Up to 52 weeks ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 ]
  19. 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 ]
  20. Change from Baseline in the mTSS at Week 52 [ Time Frame: Baseline; Week 52 ]
  21. Proportion of Participants with No Radiographic Progression from Baseline at Weeks 24 and 52 [ Time Frame: Baseline; Weeks 24 and 52 ]
  22. 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 ]
  23. 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 ]
  24. 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 ]
  25. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
  • 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.


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): NCT02889796


  Show 237 Study Locations
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02889796     History of Changes
Other Study ID Numbers: GS-US-417-0301
2016-000568-41 ( EudraCT Number )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
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
Anti-Inflammatory Agents