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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

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

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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.


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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 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


Locations
Hide Hide 104 study locations
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United States, Alabama
Huntsville, Alabama, United States
United States, Arizona
Gilbert, Arizona, United States
United States, California
Covina, California, United States
Hemet, California, United States
La Jolla, California, United States
Palm Desert, California, United States
Palo Alto, California, United States
Riverside, California, United States
Upland, California, United States
Victorville, California, United States
Whittier, California, United States
United States, Florida
Aventura, Florida, United States
DeBary, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Port Richey, Florida, United States
United States, Georgia
Decatur, Georgia, United States
United States, Kansas
Kansas City, Kansas, United States
Wichita, Kansas, United States
United States, Kentucky
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
United States, Maryland
Cumberland, Maryland, United States
Frederick, Maryland, United States
United States, Massachusetts
Worcester, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
Saint Clair Shores, Michigan, United States
United States, Mississippi
Hattiesburg, Mississippi, United States
Tupelo, Mississippi, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
Freehold, New Jersey, United States
Toms River, New Jersey, United States
United States, New York
Brooklyn, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Salisbury, North Carolina, United States
United States, Ohio
Middleburg Heights, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Myrtle Beach, South Carolina, United States
Orangeburg, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
Beaumont, Texas, United States
Corpus Christi, Texas, United States
Mesquite, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Webster, Texas, United States
Argentina
Buenos Aires, Argentina
Caba, Argentina
San Juan, Argentina
Australia, Western Australia
Victoria Park, Western Australia, Australia
Belgium
Gent, Belgium
Leuven, Belgium
Merksem, Belgium
France
Montpellier, France
Germany
Berlin, Germany
Hamburg, Germany
Ratingen, Germany
Hungary
Budapest, Hungary
Gyula, Hungary
Székesfehérvár, Hungary
Israel
Haifa, Israel
Ramat Gan, Israel
Japan
Hiroshima, Japan
Izumo, Japan
Katō, Japan
Kawagoe, Japan
Kumamoto, Japan
Narashino, Japan
Okayama, Japan
Sagamihara, Japan
Sapporo, Japan
Shinjuku-Ku, Japan
Takaoka, Japan
Takasaki, Japan
Tokorozawa, Japan
Tokyo, Japan
Tomigusuku, Japan
Korea, Republic of
Seoul, Korea, Republic of
Mexico
Chihuahua, Mexico
Distrito Federal, Mexico
Mérida, Mexico
Poland
Białystok, Poland
Poznań, Poland
Warszawa, Poland
Wroclaw, Poland
Spain
Madrid, Spain
Málaga, Spain
Sabadell, Spain
Valencia, Spain
Switzerland
Sankt Gallen, Switzerland
United Kingdom
Doncaster, United Kingdom
Edinburgh, United Kingdom
Goodmayes, United Kingdom
Harlow, United Kingdom
Newcastle upon Tyne, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02873936    
Other Study ID Numbers: GS-US-417-0302
2016-000569-21 ( EudraCT Number )
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: July 2018

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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
Antirheumatic Agents