Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Written consent to participate in the study
Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA
Index knee pain for >15 days over the last month
Body mass index (BMI) ≤ 40 kg/m2
Ambulatory and in good general health

Key

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) within 12 months of Screening
IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
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
Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ

Arm && Interventions

Group	Intervention	Description
FX006 40 mg	FX006 40 mg	Single 3 mL intra-articular (IA) injection
FX006 10 mg	FX006 10 mg	Single 3 mL intra-articular (IA) injection
TCA IR 40 mg	TCA IR 40 mg	Single 1 mL intra-articular (IA) injection

Primary Outcome Measures

Name	Time	Method
Concentration of Triamcinolone Acetonide in Synovial Fluid	12 to 20 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Plasma Drug Concentrations by Time	Weeks 6, 12, 16 and 20	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).