The primary objective of this study is to evaluate the effectiveness of REGN475 compared to placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history of inadequate joint pain relief or intolerance to current analgesic therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
421
The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score.
Time frame: Baseline to week 16
Change from baseline to week 16 in the WOMAC physical function subscale score
Time frame: Baseline to week 16
Change from baseline to week 16 in the Patient Global Assessment score
Time frame: Baseline to week 16
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to week 36 (end of study)
Incidence of anti-REGN475 antibody development
Time frame: Baseline to week 36 (end of study)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Tuscon, Arizona, United States
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Hot Spring, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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El Cajon, California, United States
...and 62 more locations