Clinical trial: AP-003-B Study to Evaluate the Efficacy And Safety Of An Intra-Articular Injection Of Ampion™ In Adults With Pain With Osteoarthritis Of The Knee (NCT02556710)

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;

          -  Male or female, 40 years to 85 years old (inclusive);

          -  Must be ambulatory;

          -  Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of
             OA and supported by radiological evidence (Kellgren Lawrence Grade II to IV) read by a
             central reader;

          -  WOMAC 5-point Likert pain subscale <1.5 in the contralateral knee;

          -  Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the
             WOMAC Index 3.1 5-point Likert Pain Subscale);

          -  Moderate to moderately-severe OA pain in the index knee (even if chronic doses of
             nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks
             prior to screening, have been/are being used);

          -  Ability to discontinue NSAID use at Screening visit and/or 72 hours prior to the
             Baseline visit and for the duration of the clinical study (low dose Aspirin is allowed
             during the study);

          -  No analgesia (including acetaminophen [paracetamol]) taken 24 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

          -  Pregnancy or planning to become pregnant during the study.

          -  Use of the following medications:

          -  No IA injected pain medications in the study knee during the study

          -  No analgesics containing opioids.

          -  NSAIDs are not permitted during the study; acetaminophen is available as a rescue
             medication during the study from the provided supply.

          -  No topical treatment on osteoarthritis index knee during the study

          -  No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study
             (treatment such as low dose Aspirin and Plavix are allowed)

          -  No systemic treatments that may interfere with safety or efficacy assessments during
             the study

          -  No immunosuppressants

          -  No use of corticosteroids

          -  No human albumin treatment in the 3 months before randomization or throughout the
             duration of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment