Safety of Repeat Dose of FX006
Key Inclusion Criteria
- At least 40 years old
- Symptoms associated with OA of the index knee for at least six months prior to screening
- Currently meets American College of Rheumatology criteria for OA
- Ambulatory and in good general health
Key Exclusion Criteria
- Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or arthritis associated with inflammatory bowel disease
- History of infection in the index knee joint
- Clinical signs and symptoms of active knee infection or crystal disease of the index knee within one month of screening
Full Study Name
An Open-Label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee (IRB no. 46557)
This study focuses on patients diagnosed with osteoarthritis (OA) of the knee. The purpose of the study is to examine the use of an investigational drug called FX006 on patients with symptomatic OA of the knee. OA produces pain in the knee (and other joints) that is typically worsened by activities such as long-distance walking or climbing stairs and is alleviated by rest. Researchers aim to determine the overall safety and tolerability of administering FX006 more than once. The drug is being developed to potentially treat patients with symptomatic OA of the knee.
FX006 is a new form of a steroid injection already available for this condition, triamcinolone acetonide (Kenalog-40). The active ingredient of FX006 is also triamcinolone acetonide, but FX006 is designed to relieve the pain for longer than the available treatment.