Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: FX006 10 mg; FX006 40 mg; TCA IR 40 mg
Intervention description: Extended-release formulation; Extended-release formulation; Immediate-release formulation
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; FX006; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: osteoarthritis; knee; corticosteroids; triamcinolone acetonide; synovial fluid

Summary:

      The purpose of this study was to characterize the local duration of exposure of TCA for 2
      doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Written consent to participate in the study

          -  Willingness and ability to comply with the study procedures and visit schedules and
             ability to follow verbal and written instructions

          -  Has documented diagnosis of OA of the index knee made at least 6 months prior to
             Screening

          -  Currently meets American Collage of Rheumatology Criteria (clinical and radiological)
             for OA

          -  Index knee pain for >15 days over the last month

          -  Body mass index (BMI) ≤ 40 kg/m2

          -  Ambulatory and in good general health

        Key Exclusion Criteria:

          -  History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing
             spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or
             amyloidosis

          -  History of arthritides due to crystals (e.g., gout, pseudogout)

          -  History of infection in the index joint

          -  Clinical signs and symptoms of active knee infection or crystal disease of the index
             knee

          -  Presence of surgical hardware or other foreign body in the index knee

          -  Unstable joint (such as a torn anterior cruciate ligament) within 12 months of
             Screening

          -  IA corticosteroid (investigational or marketed) in any joint within 6 months of
             Screening

          -  IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of
             Screening

          -  Oral corticosteroids (investigational or marketed) within 1 month of Screening

          -  Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2
             weeks of Screening

          -  Any other IA investigational drug/biologic within 6 months of Screening

          -  Prior use of FX006

          -  Prior arthroscopic or open surgery of the index knee within 12 months of Screening

          -  Planned/anticipated surgery of the index knee during the study period

          -  Active or history of malignancy within the last 5 years, with the exception of
             resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected
             cervical atypia or carcinoma in situ