ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 11 for:    filgotinib and rheumatoid arthritis

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)

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: NCT02873936
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : July 25, 2018
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 biologic disease-modifying anti-rheumatic drug(s) (DMARDs) treatment.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 27, 2016
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : June 26, 2018

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 + a stable dose of permitted csDMARD(s)
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)

Experimental: Filgotinib Dose B
Filgotinib dose B + placebo to match filgotinib dose A + a stable dose of permitted csDMARD(s)
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)

Placebo Comparator: Placebo
Placebo to match filgotinib dose A + placebo to match filgotinib dose B + a stable dose of permitted csDMARD(s)
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)




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 ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24 [ Time Frame: Weeks 4, 12, and 24 ]
  4. Proportion of Participants who Achieve ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24 [ Time Frame: Weeks 4, 12, and 24 ]
  5. Proportion of Participants who Achieve ACR20 at Weeks 4 and 24 [ Time Frame: Weeks 4 and 24 ]
  6. Proportion of Participants who Achieve ACR20 Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  7. Proportion of Participants who Achieve ACR50 Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  8. Proportion of Participants who Achieve ACR70 Over Time from Day 1 through Week 24 [ Time Frame: Up to 24 weeks ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 ]
  19. 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 ]
  20. 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 ]
  21. 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 ]


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.


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 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.


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): NCT02873936


  Show 104 Study Locations
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02873936     History of Changes
Other Study ID Numbers: GS-US-417-0302
2016-000569-21 ( EudraCT Number )
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents