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

NCT02873936 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: GS-US-417-03022016-000569-21
• Study Type: interventional
• Target: 449
• Locations: 15 countries
• Sites: 104

Brief Summary

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12

  ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.

  Week 12

Secondary Outcomes (40)

• Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12

  Baseline; Week 12

• Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12

  Week 12

• Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12

  Baseline; Week 12

• Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24

  Week 24

• Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12

  Baseline; Week 12

Study Arms (3)

Filgotinib 200 mg

EXPERIMENTAL

Filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)

Drug: Filgotinib; Drug: Placebo to match filgotinib; Drug: csDMARDs

Filgotinib 100 mg

EXPERIMENTAL

Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s)

Drug: Filgotinib; Drug: Placebo to match filgotinib; Drug: csDMARDs

Placebo

PLACEBO COMPARATOR

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)

Drug: Placebo to match filgotinib; Drug: csDMARDs

Interventions

Filgotinib DRUG

Tablet(s) administered orally once daily

Also known as: GS-6034

Filgotinib 100 mg; Filgotinib 200 mg

Placebo to match filgotinib DRUG

Tablet(s) administered orally once daily

Filgotinib 100 mg; Filgotinib 200 mg; Placebo

csDMARDs DRUG

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)

Filgotinib 100 mg; Filgotinib 200 mg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of RA (2010 American College of Rheumatology \[ACR\]/European League Against Rheumatism \[EULAR\] 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

You may not qualify if:

• Previous treatment with any janus kinase (JAK) inhibitor

Sponsors & Collaborators

• Gilead Sciences: lead
• Galapagos NV: collaborator

Study Sites (104)

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Huntsville, Alabama, United States

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Gilbert, Arizona, United States

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Covina, California, United States

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Hemet, California, United States

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La Jolla, California, United States

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Palm Desert, California, United States

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Palo Alto, California, United States

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Riverside, California, United States

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Upland, California, United States

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Victorville, California, United States

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Whittier, California, United States

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Aventura, Florida, United States

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DeBary, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Port Richey, Florida, United States

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Decatur, Georgia, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Elizabethtown, Kentucky, United States

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Lexington, Kentucky, United States

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Cumberland, Maryland, United States

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Frederick, Maryland, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Hattiesburg, Mississippi, United States

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Tupelo, Mississippi, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Lebanon, New Hampshire, United States

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Freehold, New Jersey, United States

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Toms River, New Jersey, United States

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Brooklyn, New York, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Salisbury, North Carolina, United States

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Middleburg Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Orangeburg, South Carolina, United States

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Memphis, Tennessee, United States

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Beaumont, Texas, United States

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Corpus Christi, Texas, United States

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Mesquite, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Webster, Texas, United States

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Buenos Aires, Argentina

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Caba, Argentina

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San Juan, Argentina

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Victoria Park, Western Australia, Australia

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Ghent, Belgium

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Leuven, Belgium

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Merksem, Belgium

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Montpellier, France

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Berlin, Germany

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Hamburg, Germany

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Ratingen, Germany

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Budapest, Hungary

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Gyula, Hungary

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Székesfehérvár, Hungary

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Haifa, Israel

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Ramat Gan, Israel

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Hiroshima, Japan

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Izumo, Japan

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Katō, Japan

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Kawagoe, Japan

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Kumamoto, Japan

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Narashino, Japan

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Okayama, Japan

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Sagamihara, Japan

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Sapporo, Japan

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Shinjuku-Ku, Japan

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Takaoka, Japan

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Takasaki, Japan

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Tokorozawa, Japan

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Tokyo, Japan

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Tomigusuku, Japan

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Chihuahua City, Mexico

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Distrito Federal, Mexico

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Mérida, Mexico

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Bialystok, Poland

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Poznan, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Seoul, South Korea

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Madrid, Spain

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Málaga, Spain

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Sabadell, Spain

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Valencia, Spain

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Sankt Gallen, Switzerland

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Doncaster, United Kingdom

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Edinburgh, United Kingdom

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Goodmayes, United Kingdom

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Harlow, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Related Publications (8)

• Genovese MC, Kalunian KC, Walker D, Gottenberg JE, De Vlam K, Mozaffarian N, et al. Safety and Efficacy of Filgotinib in a Phase 3 Trial of Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic Dmards [Abstract No. L06]. ACR/ARHP Annual Meeting; 2018 19-24 October; Chicago, IL, USA.

  RESULT

• 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.

  PMID: 31334793 RESULT

• Taylor PC, Downie B, Han L, Hawtin R, Hertz A, Moots RJ, Takeuchi T. Patients with High Baseline Neutrophil-to-Lymphocyte Ratio Exhibit Better Response to Filgotinib as Treatment for Rheumatoid Arthritis. Rheumatol Ther. 2024 Oct;11(5):1383-1392. doi: 10.1007/s40744-024-00695-w. Epub 2024 Jul 10.

  PMID: 38985247 DERIVED

• Curtis JR, Emery P, Downie B, Zhong Y, Liu J, Han L, Hawtin RE, Burmester GR. Filgotinib Demonstrates Efficacy in Rheumatoid Arthritis Independent of Smoking Status: Post Hoc Analysis of Phase 3 Trials and Claims-Based Analysis. Rheumatol Ther. 2024 Feb;11(1):177-189. doi: 10.1007/s40744-023-00619-0. Epub 2023 Dec 6.

  PMID: 38057656 DERIVED

• Balsa A, Wassenberg S, Tanaka Y, Tournadre A, Orzechowski HD, Rajendran V, Lendl U, Stiers PJ, Watson C, Caporali R, Galloway J, Verschueren P. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Dec;10(6):1555-1574. doi: 10.1007/s40744-023-00599-1. Epub 2023 Sep 25.

  PMID: 37747626 DERIVED

• Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.

  PMID: 36205910 DERIVED

• Bingham CO 3rd, Walker D, Nash P, Lee SJ, Ye L, Hu H, Khalid JM, Combe B. The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies. Arthritis Res Ther. 2022 Jan 3;24(1):11. doi: 10.1186/s13075-021-02677-7.

  PMID: 34980223 DERIVED

• Takeuchi T, Matsubara T, Atsumi T, Amano K, Ishiguro N, Sugiyama E, Yamaoka K, Genovese MC, Kalunian K, Walker D, Gottenberg JE, de Vlam K, Bartok B, Pechonkina A, Kondo A, Gao J, Guo Y, Tasset C, Sundy JS, Tanaka Y. Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global phase 3 study (FINCH 2). Mod Rheumatol. 2022 Jan 5;32(1):59-67. doi: 10.1080/14397595.2020.1859675.

  PMID: 33274687 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: July 27, 2016
• Primary Completion: March 20, 2018
• Study Completion: June 26, 2018
• Last Updated: May 13, 2021
• Results First Posted: January 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); ME (3); IL (2); KR (1); BE (3); AR (3); DE (3); HU (3); US (55); GB (5); CH (1); ES (4); AU (1); PL (4); JP (15)