The primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745) versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and methotrexate in adults with moderate to severe rheumatoid arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
Administered via subcutaneous injection once weekly
Administered via subcutaneous injection once weekly
Administered orally weekly as part of the participant's current treatment regimen
Stanford University
Palo Alto, California, United States
Omega Research Consultants, LLC
DeBary, Florida, United States
G. Timothy Kelly, MD
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Change From Baseline in DAS28(CRP) at Week 12
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and 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 That Achieve DAS28(CRP) ≤ 3.2 at Week 12
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and 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: Week 12
Percentage of Participants That Achieve DAS28(CRP) < 2.6 at Week 12
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and 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: Week 12
Plasma Concentration of Andecaliximab
The plasma concentrations of andecaliximab were not collected and were not analyzed.
Time frame: Day 4 or 6 (± 1 day)
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An approved stable subcutaneous formulation of one of the following TNF inhibitors may include adalimumab, certolizumab, etanercept, or golimumab.
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Tekton Research
Austin, Texas, United States
Accurate Clinical Research
San Antonio, Texas, United States