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Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

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ClinicalTrials.gov Identifier: NCT02885181
Recruitment Status : Completed
First Posted : August 31, 2016
Results First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: GS-9876 Drug: Filgotinib Drug: GS-9876 placebo Drug: Filgotinib placebo Drug: Methotrexate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
Actual Study Start Date : September 21, 2016
Actual Primary Completion Date : August 22, 2017
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GS-9876 - 30 mg
GS-9876 30 mg + filgotinib placebo for 12 weeks
 Drug: GS-9876
One tablet administered orally once daily

Drug: Filgotinib placebo
Two tablets administered orally once daily

Drug: Methotrexate
Background therapy with methotrexate administered orally or parenterally once weekly
Experimental: GS-9876 - 10 mg
GS-9876 10 mg + filgotinib placebo for 12 weeks
 Drug: GS-9876
One tablet administered orally once daily

Drug: Filgotinib placebo
Two tablets administered orally once daily

Drug: Methotrexate
Background therapy with methotrexate administered orally or parenterally once weekly
Experimental: Filgotinib
Filgotinib + GS-9876 placebo for 12 weeks
 Drug: Filgotinib
Two tablets administered orally once daily

Drug: GS-9876 placebo
One tablet administered orally once daily

Drug: Methotrexate
Background therapy with methotrexate administered orally or parenterally once weekly
Placebo Comparator: Placebo
GS-9876 placebo + filgotinib placebo for 12 weeks
 Drug: GS-9876 placebo
One tablet administered orally once daily

Drug: Filgotinib placebo
Two tablets administered orally once daily

Drug: Methotrexate
Background therapy with methotrexate administered orally or parenterally once weekly


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12 [ Time Frame: Baseline; Week 12 ]
    Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.


Secondary Outcome Measures :
  1. Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12 [ Time Frame: Week 12 ]
    American College of Rheumatology (ACR)20 response was defined as having ≥ 20% improvement from baseline in the number of tender and the number of swollen joints, and a 20% improvement in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity (PhGA), Participant's Global Assessment of Disease Activity (PtGA), Participant's pain assessment, Participant's assessment of physical function (HAQ-DI) score, and C-reactive protein (CRP).

  2. Percentage of Participants Who Achieved ACR50 Improvement at Week 12 [ Time Frame: Week 12 ]
    ACR50 response was defined as having ≥ 50% improvement from baseline in the number of tender and the number of swollen joints, and a 50% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.

  3. Percentage of Participants Who Achieved ACR70 Improvement at Week 12 [ Time Frame: Week 12 ]
    ACR70 response was defined as having ≥ 70% improvement from baseline in the number of tender and the number of swollen joints, and a 70% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.

  4. Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12 [ Time Frame: Baseline; Week 12 ]
    The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), a swollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1
  • Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 12 weeks
  • No evidence of active or latent tuberculosis

Key Exclusion Criteria:

  • Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6 months prior to the first dose of study drug and documented return of CD19+ cells at screening
  • Prior treatment with any commercially available or investigational spleen tyrosine kinase (SYK) inhibitor
  • Concurrent treatment with any other conventional synthetic DMARD (csDMARD) other than MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate wash out as defined in the protocol)
  • Concurrent treatment with any biological disease modifying anti-rheumatic drug (bDMARD)(prior bDMARD treatment allowed if appropriate wash out as defined in the protocol). Prior failure to treatment with bDMARDs is not an exclusion criterion.

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations
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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): NCT02885181


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] April 8, 2016
Study Protocol: Amendment 1  [PDF] June 27, 2016
Study Protocol: Amendment 2  [PDF] July 11, 2016
Statistical Analysis Plan  [PDF] October 26, 2017

More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02885181    
Other Study ID Numbers: GS-US-379-1582
2016-001496-75 ( EudraCT Number )
First Posted: August 31, 2016    Key Record Dates
Results First Posted: September 19, 2018
Last Update Posted: September 19, 2018
Last Verified: August 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
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