pharmacokinetic and pharmacodynamic study of fx006 in patients with osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of fx006 in patients with osteoarthritis of the knee.

this study was a double-blind, randomized, parallel-group, active comparator design. the study was conducted in male and female patients ≥35 years of age with symptomatic oa of the knee. twenty-four (24) patients with knee oa were randomized (1:1:1:1) and treated with a single ia injection of either 10, 40, or 60 mg of fx006 or 40 mg of tca ir. each patient was evaluated for a total of 6 weeks following a single ia injection. following screening, safety, pk and pharmacodynamics (pd) were evaluated during one (1) 48-hour in-patient period (day -1 to day 2), two (2) 24-hour in-patient periods (day 14-15 and day 42-43) and seven (7) out-patient visits (days 3, 4, 5, 8, 22, 29 and 36).

Eligibility criteria:
main inclusion criteria: * willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions * male or female \>=35 years of age * diagnosis of unilateral or bilateral oa of the knee for at least 6 months prior to screening with confirmation of oa according to american college of rheumatology criteria for classification of idiopathic oa of the knee (clinical and radiological) based on an x-ray performed within 6 months prior to screening or during the screening period * body mass index (bmi) ≤ 40 kg/m2 * willingness to abstain from use of the protocol-specified restricted medications main 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) * ia corticosteroid (investigational or marketed) in any joint within 3 months of screening * ia hyaluronic acid (investigational or marketed) in the index knee within 6 months of screening * oral, inhaled or intranasal corticosteroids (investigational or marketed) within 1 month of screening * 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 * history of or active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years * insulin-dependent diabetes * history of or active cushing's syndrome * any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes) * skin breakdown at the knee where the injection would take place * women of child-bearing potential not using effective contraception or who are pregnant or nursing

Keywords: osteoarthritis knee corticosteroid intra-articular injection