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

FX006-2013-005

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.

2013-11-01

2014-04-01

2014-04-01

Completed

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}

2024-01-24