study to compare exposure of ta following administration of either fx006 or tacs in patients with bilateral knee oa

Conditions: Bilateral Knee Osteoarthritis

Summary: this is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either fx006 or tacs.

this is a randomized, open label, parallel group study that will be conducted in male and female patients ≥ 40 years of age with bilateral knee oa. approximately 24 patients will be randomized to one of two treatment groups (1:1) and treated with ia injections to both knees of either: * extended-release fx006 64 mg total dose (approximately 12 patients) or * immediate-release tacs 80 mg total dose (approximately 12 patients) each patient will be screened to confirm the diagnosis of oa and eligibility based on the inclusion/exclusion requirements and will be randomized to treatment on day 1. following screening, pharmacokinetics (pk) and safety will be evaluated at 6 out-patient visits scheduled on study days 1 \[calendar day of injection\], 2, 8, 15, 29, and 43.

Eligibility criteria:
inclusion criteria: * written consent to participate in the study * male or female greater than or equal to 40 years of age * symptoms consistent with oa in both knees for greater than or equal to 6 months prior to screening (patient reported is acceptable) * currently meets acr criteria (clinical and radiological) for oa in both knees * knee pain in both knees for greater than 15 days over the last month (as reported by the patient) * body mass index (bmi) less than or equal to 40 kg/m2 * morning serum cortisol result within normal range at screening (5-23 mcg/dl or 138-635 nmol/dl) * ambulatory and in good general health * willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions. * willing to abstain from use of protocol-restricted medications during the study exclusion criteria: * reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease * history of infection in either knee joint * clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of screening * unstable joint (such as a torn anterior cruciate ligament) in either knee within 12 months of screening * presence of surgical hardware or other foreign body in either knee * surgery or arthroscopy of either knee within 12 months of screening * ia treatment of any joint with any of the following agents within six (6) months of screening: any corticosteroid preparation (investigational or marketed, including fx006), any biologic agent (e.g., platelet rich plasma (prp) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed). * ia treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of screening * parenteral or oral corticosteroids (investigational or marketed) within 3 months of screening * inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of screening * females who are pregnant or nursing or plan to become pregnant during the study; men who plan to conceive during the study

Keywords: osteoarthritis knee corticosteroid bilateral pain intra-articular injection