Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee pain corticosteroid intra-articular injection
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 81
Healthy volunteers: no

Brief 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.

Detailed description:
This study employed an open-label, single administration design and was conducted in male and female patients ≥40 years of age with OA of the knee.

Patients were enrolled sequentially with at least 10 patients per cohort as follows:

Cohort A: FX006 32 mg, Final Visit at Week 20 Cohort B: FX006 32 mg, Final Visit at Week 16 Cohort C: FX006 32 mg, Final Visit at Week 12 Cohort D: FX006 32 mg, Final Visit at Week 6 Cohort E: FX006 32 mg, Final Visit at Week 1 Cohort F: TCA IR 40 mg, Final Visit Week 6

Each patient was screened to confirm eligibility and assigned to a cohort on Day 1/baseline. Each patient was evaluated for safety during his/her participation in the study at 6, 12, 16, or 20 weeks following a single IA injection depending on the assigned Cohort, and plasma and synovial fluid was collected for drug concentration measurements.

Safety and tolerability was assessed by physical examinations, index knee examinations, vital signs, clinical laboratory evaluations, and adverse events (AEs).

No efficacy assessments were employed in this study.

Arms:
arm 1: Single 5 mL intra-articular (IA) injection Extended-release formulation arm 2: Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation

Interventions: intervention 1: FX006 32 mg intervention 2: TCA IR 40
Intervention descriptions: intervention 1: Single 5 mL IA injection intervention 2: Single 1 mL IA injection

Protocol document: