Clinical trial NCT02003365: Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis
knee
corticosteroids
triamcinolone acetonide
synovial fluid
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of Triamcinolone Acetonide in Synovial Fluid
timeFrame: 12 to 20 weeks
Secondary outcomes:
measure: Plasma Drug Concentrations by Time
timeFrame: Weeks 6, 12, 16 and 20
Other outcomes:
Locations:
city: Paducah
country: United States
state: Kentucky
city: Duncansville
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Flexion Therapeutics
name: Neil Bodick, MD
role: STUDY_DIRECTOR
References: