Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
Condition: Post-traumatic Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: FX006 32 mg; TCA IR 40 mg
Intervention description: Experimental; Comparator
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: 6.0
Sex: All
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Post-traumatic; Knee; Pain; Corticosteroid; Intra-articular; Injection

Summary:

      This study was a double-blind, randomized, parallel group, proof of concept study comparing
      FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with
      post-traumatic osteoarthritis of the knee.
    

Eligibility criteria:

        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 ≥20 and ≤50 years of age

          -  Diagnosis of post-traumatic OA of the knee

          -  Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee within 6 months prior to or at
             Screening

          -  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 and therapies during the
             study

        Exclusion Criteria:

          -  Prior osteotomy of the index knee

          -  Any condition that could possibly confound the patient's assessment of index knee pain
             in the judgement of the Investigator (i.e., ipsilateral hip OA, gout, radicular low
             back pain and hip pain that is referred to the knee that could cause misclassifcation,
             pain in any other area of the lower extremeties or back that is equal to or greater
             than the index knee pain)

          -  Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing
             spondylitis, arthritis associated with inflammatory bowel disease

          -  History of, or clinical signs and symptoms of active infection of the index knee

          -  Crystal disease of the index knee within one month of Screening

          -  Disease secondary to surgical treatment of Shatzker grade IV, V, or VI tibial plateau
             fractures (OTA classification C2 or C3); surgical treatment of OTA calssifcation C2 or
             C3 distal femur fractures; or >2mm of articular incongruity after surgery

          -  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

          -  Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1
             month of Screening

          -  Any other IA investigational drug/biologic within 6 months of Screening

          -  Prior use of FX006

          -  Prior arthroplasty of any type of the index knee or planned/anticipated surgery of the
             index knee during the study period

          -  Type 1 or Type 2 diabetes requiring insulin

          -  Women of child-bearing potential not using effective contraception or who are pregnant
             or nursing