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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GS-9876
Filgotinib
GS-9876 placebo
Filgotinib placebo
Methotrexate
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Omega Research Consultants
  • Sarasota Arthritis Research Center
  • Medical Associates of North Georgia
  • Center For Arthritis and Osteoporosis
  • Albuquerque Center For Rheumatology
  • Altoona Center for Clinical Research
  • Accurate Clinical Management - Najam
  • Accurate Clinical Research Inc.
  • Medical Center Research LLC
  • MHAT-Plovdiv AD
  • Umhat Kaspela
  • NMTH Tsar Boris III
  • A-Shine s.r.o.
  • Medical Plus, S.R.O.
  • LLC Arensia Exploratory Medicine
  • ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital
  • ClinicMed Badurski i wspolnicy Spolka Jawna
  • Kharkiv City Hospital 8
  • Medical Center_Clinic of International Institute of clinical Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

GS-9876 - 30 mg

GS-9876 - 10 mg

Filgotinib

Placebo

Arm Description

GS-9876 30 mg + filgotinib placebo for 12 weeks

GS-9876 10 mg + filgotinib placebo for 12 weeks

Filgotinib + GS-9876 placebo for 12 weeks

GS-9876 placebo + filgotinib placebo for 12 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at 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

Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at 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).
Percentage of Participants Who Achieved ACR50 Improvement at 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.
Percentage of Participants Who Achieved ACR70 Improvement at 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.
Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at 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.

Full Information

First Posted
August 26, 2016
Last Updated
August 21, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02885181
Brief Title
Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 21, 2016 (Actual)
Primary Completion Date
August 22, 2017 (Actual)
Study Completion Date
September 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GS-9876 - 30 mg
Arm Type
Experimental
Arm Description
GS-9876 30 mg + filgotinib placebo for 12 weeks
Arm Title
GS-9876 - 10 mg
Arm Type
Experimental
Arm Description
GS-9876 10 mg + filgotinib placebo for 12 weeks
Arm Title
Filgotinib
Arm Type
Experimental
Arm Description
Filgotinib + GS-9876 placebo for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
GS-9876 placebo + filgotinib placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
GS-9876
Intervention Description
One tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Filgotinib
Intervention Description
Two tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
GS-9876 placebo
Intervention Description
One tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Filgotinib placebo
Intervention Description
Two tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Background therapy with methotrexate administered orally or parenterally once weekly
Primary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12
Description
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.
Time Frame
Baseline; Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12
Description
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).
Time Frame
Week 12
Title
Percentage of Participants Who Achieved ACR50 Improvement at Week 12
Description
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.
Time Frame
Week 12
Title
Percentage of Participants Who Achieved ACR70 Improvement at Week 12
Description
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.
Time Frame
Week 12
Title
Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12
Description
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.
Time Frame
Baseline; Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Omega Research Consultants
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Sarasota Arthritis Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Medical Associates of North Georgia
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
Facility Name
Center For Arthritis and Osteoporosis
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
Facility Name
Albuquerque Center For Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Accurate Clinical Management - Najam
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Accurate Clinical Research Inc.
City
Stafford
State/Province
Texas
ZIP/Postal Code
77477
Country
United States
Facility Name
Medical Center Research LLC
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
MHAT-Plovdiv AD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Umhat Kaspela
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
NMTH Tsar Boris III
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
A-Shine s.r.o.
City
Plzen
ZIP/Postal Code
31200
Country
Czechia
Facility Name
Medical Plus, S.R.O.
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Facility Name
LLC Arensia Exploratory Medicine
City
T'bilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
ClinicMed Badurski i wspolnicy Spolka Jawna
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Kharkiv City Hospital 8
City
Kharkiv
ZIP/Postal Code
140176
Country
Ukraine
Facility Name
Medical Center_Clinic of International Institute of clinical Studies
City
Kyiv
ZIP/Postal Code
2068
Country
Ukraine

12. IPD Sharing Statement

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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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