Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip
Condition: Osteoarthritis of the Shoulder; Osteoarthritis of the Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Intervention: FX006 32 mg; TAcs 40 mg
Intervention description: Extended-release 32 mg FX006 IA injection; Immediate-release 40mg TAcs 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: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Shoulder; Hip; Pain; Intra-articular; Injection; Corticosteroid

Summary:

      This is an open-label study to compare systemic exposure to triamcinolone acetonide following
      a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide
      suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written consent to participate in the study

          -  Male or female greater than or equal to 40 years of age

          -  Body mass index (BMI) less than or equal to 40 kg/m2

          -  Ambulatory and in good general health

          -  Willing and able to comply with the study procedures and visit schedules and able to
             follow verbal and written instructions

          -  Willing to abstain from use of protocol-restricted treatments from Screening through
             End-of-Study visit

          -  Symptoms consistent with OA of the index joint for ≥ 6 months prior to Screening
             (patient reported is acceptable)

          -  Pain in the index joint for greater than15 days over the last month (as reported by
             the patient)

          -  For Shoulder OA patients: Radiologic findings of OA of the index shoulder meeting the
             Samilson-Prieto (S-P) Classification Grades 2 or 3

          -  For Hip OA patients: ACR Criteria (clinical and radiological) for OA of the index hip

        Exclusion Criteria:

          -  Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,
             or arthritis associated with inflammatory bowel disease

          -  History of infection in the index joint

          -  Clinical findings consistent with active infection or crystal disease in the index
             joint within 1 month of Screening

          -  History of fracture in the index limb within 12 months of Screening, or fracture with
             sequelae at any time

          -  Planned or anticipated surgery of the index joint during the study period

          -  Index joint instability or history of acute dislocation within 12 months of Screening

          -  If shoulder is the index joint, history of full or partial rotator cuff tear or
             significantly compromised rotator cuff function that, in the opinion for the
             Investigator, increases the difficulty or risk of IA injection

          -  Presence of surgical hardware or other foreign body in the index joint

          -  Surgery or arthroscopy of the index joint within 12 months of Screening

          -  IA treatment of any joint with any of the following agents within 6 months of
             Screening:

          -  Any corticosteroid preparation (investigational or marketed, including FX006), any
             biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy,
             amniotic fluid injection; investigational or marketed)

          -  IA treatment of the index joint with hyaluronic acid (investigational or marketed)
             within 6 months of Screening

          -  Parenteral or oral corticosteroids (investigational or marketed) within 3 months of
             Screening

          -  Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2
             weeks of Screening

          -  Females who are pregnant or nursing or plan to become pregnant during the study; men
             who plan to conceive during the study