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.
This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee. Patients were enrolled sequentially with 8 patients per cohort, as follows: Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12 Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12 Each patient was evaluated for up to 12, 16, or 20 weeks following a single IA injection depending on the assigned cohort. Following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Extended-release formulation
Extended-release formulation
Immediate-release formulation
Unnamed facility
Paducah, Kentucky, United States
Unnamed facility
Duncansville, Pennsylvania, United States
Unnamed facility
Dallas, Texas, United States
Concentration of Triamcinolone Acetonide in Synovial Fluid
Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population. Values recorded as lower limit of quantification (LLOQ) (\< 50 pg/mL) were counted as half the value below limit of quantification (BLQ).
Time frame: 12 to 20 weeks
Plasma Drug Concentrations by Time
Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population. Values recorded as lower limit of quantification (LLOQ) (\< 10 pg/mL) were counted as half the value below limit of quantification (BLQ).
Time frame: Weeks 6, 12, 16 and 20
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