Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: FX006 32 mg; TCA IR 40
Intervention description: Single 5 mL IA injection; Single 1 mL IA injection
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: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: osteoarthritis; knee; pain; corticosteroid; intra-articular; injection

Summary:

      The objectives of this study were to characterize the local extent and duration of exposure
      of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the
      safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40
      mg of TCA IR in patients with OA of the knee.
    

Eligibility criteria:

        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

          -  Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient
             reported is acceptable)

          -  Currently meets American College of Rheumatology (ACR) Criteria (clinical and
             radiological) for OA

          -  Index knee pain for >15 days over the last month (as reported by the patient)

          -  Body mass index (BMI) ≤ 40 kg/m2

          -  Ambulatory and in good general health

        Exclusion Criteria:

          -  Fibromyalgia, Reiter's syndrome, 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 1 month of Screening

          -  Presence of surgical hardware or other foreign body in the index knee

          -  Unstable joint 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

          -  Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3
             months of Screening

          -  Oral corticosteroids (investigational or marketed) within 1 month of Screening

          -  Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2
             weeks of Screening

          -  Any other IA investigational drug/biologic use within 6 months of Screening or 5
             half-lives (whichever is longer)

          -  Prior use of FX006

          -  Women of child-bearing potential not using effective contraception or who are pregnant
             or nursing