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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-label, Single Administration Study to Characterize the Local Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis (OA) of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: FX006 10 mg
* Drug: FX006 40 mg
* Drug: TCA IR 40 mg


Participation Criteria
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Eligibility Criteria
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Key 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FX006 10 mg<br>Single 3 mL intra-articular (IA) injection | Drug: FX006 10 mg<br>* Extended-release formulation<br>|
| Experimental: FX006 40 mg<br>Single 3 mL intra-articular (IA) injection | Drug: FX006 40 mg<br>* Extended-release formulation<br>|
| Active Comparator: TCA IR 40 mg<br>Single 1 mL intra-articular (IA) injection | Drug: TCA IR 40 mg<br>* Immediate-release formulation<br>* Other names: Triamcinolone Acetonide Crystalline Suspension (TAcs);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Weeks 6, 12, 16 and 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, knee, corticosteroids, triamcinolone acetonide, synovial fluid