Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: FX006 10 mg; FX006 40 mg; FX006 60 mg; TCA IR 40
Intervention description: single 3 mL IA injection; single 3 mL IA injection; single 3 mL IA injection; single 1 mL IA injection
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; FX006; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: osteoarthritis; knee; corticosteroid; intra-articular; injection

Summary:

      The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics
      of FX006 in patients with osteoarthritis of the knee.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Willingness and ability to comply with the study procedures and visit schedules and
             ability to follow verbal and written instructions

          -  Male or female >=35 years of age

          -  Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to
             Screening with confirmation of OA according to American College of Rheumatology
             Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological)
             based on an X-ray performed within 6 months prior to Screening or during the Screening
             period

          -  Body mass index (BMI) ≤ 40 kg/m2

          -  Willingness to abstain from use of the protocol-specified restricted medications

        Main 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)

          -  IA corticosteroid (investigational or marketed) in any joint within 3 months of
             Screening

          -  IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of
             Screening

          -  Oral, inhaled or intranasal corticosteroids (investigational or marketed) within 1
             month of Screening

          -  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

          -  History of or active malignancy, with the exception of resected basal cell carcinoma,
             squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
             within 5 years

          -  Insulin-dependent diabetes

          -  History of or active Cushing's syndrome

          -  Any other clinically significant acute or chronic medical conditions (e.g.,
             uncontrolled diabetes)

          -  Skin breakdown at the knee where the injection would take place

          -  Women of child-bearing potential not using effective contraception or who are pregnant
             or nursing