- Symptomatic OA of the knee for â‰¥3 months diagnosed prior to screening as per American
College of Rheumatology clinical criteria.
- Radiographic evidence of tibiofemoral OA of index knee (Kellgren-Lawrence grade 2-3),
as confirmed at screening.
- Moderate to severe index knee pain due to OA requiring use of analgesic medication.
- Willing to discontinue use of all analgesic medication (aside from rescue medication)
during the study.
- Presence of, or history of,
1. any inflammatory arthritis (e.g. gout, reactive arthritis, psoriatic arthritis,
seronegative spondylarthropathy, septic arthritis, previous diagnosis of
pseudogout in target joint with proven crystals on joint aspiration or elevated
C-Reactive Protein (CRP) at time of knee arthritis flare),
2. RPOA, osteonecrosis, osteoporotic fracture or any other painful joint disease
other than OA,
3. Secondary causes of OA; other rheumatologic or musculoskeletal conditions (e.g.,
rheumatoid arthritis, fibromyalgia, septic arthritis, congenital abnormality).
- Orthopaedic surgery of a lower extremity or any major surgery within the previous 6
months prior to Visit 1 or has plans for surgical intervention during the study.
- Symptomatic hip OA.
- A history of partial or complete joint replacement surgery in the index knee at any
time or anticipating knee surgery during the study period.
- Significant knee injury or any knee surgery (including arthroscopy) in the index knee
within 6 months prior to screening.
- Uncontrolled diabetes.