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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
83
One tablet administered orally once daily
Two tablets administered orally once daily
One tablet administered orally once daily
Omega Research Consultants
DeBary, Florida, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
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.
Time frame: Baseline; Week 12
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).
Time frame: Week 12
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.
Time frame: Week 12
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.
Time frame: Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Two tablets administered orally once daily
Background therapy with methotrexate administered orally or parenterally once weekly
Medical Associates of North Georgia
Canton, Georgia, United States
Center For Arthritis and Osteoporosis
Elizabethtown, Kentucky, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Accurate Clinical Management - Najam
Houston, Texas, United States
Accurate Clinical Research Inc.
Stafford, Texas, United States
Medical Center Research LLC
Webster, Texas, United States
MHAT-Plovdiv AD
Plovdiv, Bulgaria
...and 9 more locations
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.
Time frame: Baseline; Week 12