This study aims to understand the safety, drug concentration and distribution of an intra-articular injectable formulation of celecoxib, AVD275, in patients with knee osteoarthritis. One single injection at three different doses of the drug will be studied in a sequential order, and each participant will be monitored for 24 weeks over ten clinical visits.
Written consent to participate in the study; Willingness and ability to comply with the study procedures, visit schedules and follow verbal and written instructions
Male or female: 20 years to 75 years of age
Symptoms associated with OA of the knee for ≥6 months prior to screening (patient reported is acceptable); Knee OA may be unilateral or bilateral
Knee pain
Any condition that could confound the patient's assessment of index knee pain in judgement of the investigator (for example, peri-articular pain of any cause or secondary arthritis that involves the index knee, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, hemophilia, hemochromatosis, or neuropathic arthropathy, radicular lower back pain and hip pain that is referred to the knee that could cause misclassification); Other chronic pain anywhere in the body that confounds assessment of knee or that requires the use of celecoxib
Malalignment of greater than 10 degrees in the femorotibial axis of the index knee on standing; Unstable joint (such as tornanterior cruciate ligament) or traumatic knee injury to the index knee (such as meniscal root tear) within 12 months of screening
Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis, arthritis associated with inflammatory bowel disease, crystal disease of the index knee (e.g. gout or calcium pyrophosphate deposition disease), rapidly progressive osteoarthritis (defined as joint space narrowing > 1.2 mm/year), sarcoidosis or amyloidosis
Effusion at screening that likely requires joint aspiration for symptom relief from day 2 to day 83 during the study, as indicated by at least four joint drainages in the past year
Sequential
AVD275 Intra-articular Injection
DrugA long-acting formulation of celecoxib
Frequency of treatment emergent adverse events
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