Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee corticosteroids triamcinolone acetonide synovial fluid
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Single 3 mL intra-articular (IA) injection arm 2: Single 3 mL intra-articular (IA) injection arm 3: Single 1 mL intra-articular (IA) injection

Interventions: intervention 1: FX006 10 mg intervention 2: FX006 40 mg intervention 3: TCA IR 40 mg
Intervention descriptions: intervention 1: Extended-release formulation intervention 2: Extended-release formulation intervention 3: Immediate-release formulation

Protocol document: