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Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment (FINCH 2)

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ClinicalTrials.gov Identifier: NCT02873936
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE August 17, 2016
First Posted Date  ICMJE August 22, 2016
Last Update Posted Date March 18, 2019
Actual Study Start Date  ICMJE July 27, 2016
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
Proportion of Participants who Achieve an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12 [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02873936 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
  • 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 ]
  • Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 [ Time Frame: Week 12 ]
  • Proportion of Participants who Achieve ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 [ Time Frame: Weeks 4, 12, and 24 ]
  • Proportion of Participants who Achieve ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 [ Time Frame: Weeks 4, 12, and 24 ]
  • Proportion of Participants who Achieve ACR20 at Weeks 4 and 24 [ Time Frame: Weeks 4 and 24 ]
  • Proportion of Participants who Achieve ACR20 Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  • Proportion of Participants who Achieve ACR50 Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  • Proportion of Participants who Achieve ACR70 Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  • Change from Baseline in Individual Components of the ACR Response at Weeks 4, 12, and 24 and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
  • Proportion of Participants who Achieve Change in HAQ-DI of ≥ 0.22 at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  • Change from Baseline in DAS28 (CRP) at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
  • Proportion of Participants who Achieve DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  • Proportion of Participants who Achieve DAS28 (CRP) < 2.6 at Weeks 4, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  • American College of Rheumatology N (ACR-N) at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  • European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  • Change from Baseline in Clinical Diagnostic Activity Index (CDAI) at Weeks 4, 12, and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
  • Change from Baseline in Simplified Diagnostic Activity Index (SDAI) at Weeks 4, 12, and 24, and over time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
  • Absolute Value and Change from Baseline in Short-form Health Survey (SF-36) at Weeks 4, 12 and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
  • Absolute Value and Change from Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at Weeks 4, 12 and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
  • Absolute Value and Change from Baseline in the EuroQol 5 Dimensions (EQ-5D) Patient-Reported Outcomes Survey at Weeks 4, 12 and 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
  • Absolute Value and Change from Baseline in Work Productivity and Activity Impairment- Rheumatoid Arthritis (WPAI-RA) at Weeks 4, 12, 24, and Over Time from Day 1 through Week 24 [ Time Frame: Baseline and up to 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment
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 biologic disease-modifying anti-rheumatic drug(s) (DMARDs) treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Name: GS-6034
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily
  • Drug: csDMARDs
    csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
Study Arms  ICMJE
  • Experimental: Filgotinib Dose A
    Filgotinib dose A + placebo to match filgotinib dose B + a stable dose of permitted csDMARD(s)
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
    • Drug: csDMARDs
  • Experimental: Filgotinib Dose B
    Filgotinib dose B + placebo to match filgotinib dose A + a stable dose of permitted csDMARD(s)
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
    • Drug: csDMARDs
  • Placebo Comparator: Placebo
    Placebo to match filgotinib dose A + placebo to match filgotinib dose B + a stable dose of permitted csDMARD(s)
    Interventions:
    • Drug: Placebo to match filgotinib
    • Drug: csDMARDs
Publications * Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, Gao J, Guo Y, Tasset C, Sundy JS, de Vlam K, Walker D, Takeuchi T. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):315-325. doi: 10.1001/jama.2019.9055.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)
449
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2016)
423
Actual Study Completion Date  ICMJE June 26, 2018
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Have a diagnosis of RA (2010 ACR/EULAR criteria for RA), 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 screening and Day 1
  • Ongoing treatment with a stable prescription of 1 or 2 csDMARDs
  • Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for the treatment of RA to which they have had an inadequate response or intolerance

Key Exclusion Criteria:

  • Previous treatment with any janus kinase (JAK) inhibitor

NOTE: Other protocol Inclusion/ Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   France,   Germany,   Hungary,   Israel,   Japan,   Korea, Republic of,   Mexico,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Italy,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT02873936
Other Study ID Numbers  ICMJE GS-US-417-0302
2016-000569-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Galapagos NV
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP