Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.
Condition: Severe Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Ampion; Saline
Intervention description: 4 mL injection of Ampion; Saline solution, 4 mL, single intra-articular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1043.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoarthritis; osteoarthritis of the knee

Summary:

      The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment
      of pain and function in patients with severe osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide written informed consent to participate in the study

          -  Willing and able to comply with all study requirements and instructions of the site
             study staff

          -  Must be ambulatory

          -  Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of
             OAK and supported by radiological evidence (Kellgren-Lawrence Grade 4) that is not
             older than 6 months prior to the date of screening

          -  Moderate to moderately-severe osteoarthritis (OA) pain in the index knee (rating of at
             least 1.5 on the WOMAC Index 3.1 as measured by 5-point Likert Pain Subscale) assessed
             at screening

          -  Ability to temporarily discontinue nonsteroidal anti-inflammatory drug (NSAID) for 48
             hours prior to scheduled clinical efficacy evaluations

          -  No analgesia (including acetaminophen [paracetamol]) taken 12 hours prior to an
             efficacy measure

          -  No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).

        Exclusion Criteria:

          -  As a result of medical review and screening investigation, the Principal Investigator
             considers the patient unfit for the study

          -  A history of allergic reactions to human albumin (reaction to non-human albumin such
             as egg albumin is not an exclusion criterion)

          -  A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan,
             sodium caprylate)

          -  Presence of tense effusions

          -  Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or
             joint replacement in the affected knee, as assessed locally by the Principal
             Investigator

          -  Isolated patella femoral syndrome, also known as chondromalacia

          -  Any other disease or condition interfering with the free use and evaluation of the
             index knee for the duration of the trial (e.g. cancer, congenital defects, spine
             osteoarthritis)

          -  Major injury to the index knee within the 12 months prior to screening

          -  Severe hip osteoarthritis ipsilateral to the index knee

          -  Any pain that could interfere with the assessment of index knee pain (e.g. pain in any
             other part of the lower extremities, pain radiating to the knee)

          -  Any pharmacological or non-pharmacological treatment targeting OA started or changed
             during the 4 weeks prior to randomization or likely to be changed during the duration
             of the study

          -  Use of the following medications:

               1. No IA injected pain medications in the study knee during the study

               2. No analgesics containing opioids. NSAIDs may be continued at levels preceding the
                  study, however may not be used 48 hours prior to efficacy evaluations, and
                  acetaminophen is available as a rescue medication during the study from the
                  provided supply

               3. No topical treatment on osteoarthritis index knee during the study

               4. No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study
                  (treatment such as Aspirin and Plavix are allowed)

               5. No systemic treatments that may interfere with safety or efficacy assessments
                  during the study

               6. No immunosuppressants

               7. No use of corticosteroids > 10 mg prednisolone equivalent per day

               8. If corticosteroid use is ≤ 10 mg prednisolone equivalent per day, and if
                  clinically indicated, subjects should be allowed to decrease their corticosteroid
                  use. Additionally, some subjects may need to increase their steroid dose to treat
                  worsened symptoms in the treated knee, and subjects who increase their
                  corticosteroid dose above their starting dose of corticosteroid during the study
                  will be treated as "treatment failures" for efficacy analysis

          -  No human albumin treatment in the 3 months before randomization or throughout the
             duration of the study