Study of FX006 in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: FX006; TCA IR
Intervention description: Single 3 mL intra-articular injection; Single 1 mL intra-articular 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: 229.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: osteoarthritis; knee; pain; corticosteroid; intra-articular; injection

Summary:

      The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics 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 >=40 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

          -  Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)

          -  Body mass index (BMI) ≤ 40 kg/m2

          -  Willingness to abstain from use of restricted medications

        Main Exclusion Criteria

          -  Ipsilateral hip OA

          -  Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic
             conditions which could interfere with the evaluation of the index knee

          -  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 and 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

          -  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

          -  Insulin-dependent diabetes

          -  Active psychiatric disorder including psychosis and major depressive disorder

          -  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