An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.
This trial comprises a total observation period of up to 78 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
714
RTX-GRT7039 monoarticular injections or bilateral intra-articular injections.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Baseline up to Week 78
Number of Participants With TEAEs Leading to Study Discontinuation
Time frame: From Baseline up to Week 78
Number of Participants With TEAEs Representing Structural Changes as Assessed by Imaging Methods
Time frame: From Baseline up to Week 78
Change From Baseline in WOMAC Pain Subscale Score
The WOMAC pain subscale will be assessed using an 11-point numerical rating scale (NRS), where 0= no pain and 10=worst pain.
Time frame: From Baseline up to Week 12
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Arizona Arthritis and Rheumatology Associates (AARA) P.C
Glendale, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Orange County Research Institute
Anaheim, California, United States
Acclaim Clinical Research, Inc.
San Diego, California, United States
Westlake Medical Research
Thousand Oaks, California, United States
Progressive Medical Research
Port Orange, Florida, United States
Gulfcoast Research Institute
Sarasota, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Injury Care Research
Boise, Idaho, United States
...and 86 more locations