Clinical trial: A Study of ARRY-371797 in Patients With Osteoarthritis of the Knee (NCT01366014)

Eligibility criteria:
Key Inclusion Criteria:

          -  Diagnosis of OA of the knee, based on American College of Rheumatology (ACR) criteria,
             confirmed by X-ray (K-L Grade II/III within the last year).

          -  At least moderate or severe pain due to OA in one knee.

          -  On nonsteroidal anti-inflammatory drug (NSAID) 28 days previous to study start and
             willing to continue on NSAID throughout study.

          -  Discontinuation of opioids prior to study start.

          -  Additional criteria exist.

        Key Exclusion Criteria:

          -  Current or recent infection in the last 7 days; infection requiring hospitalization or
             parenteral antibiotics within the last 6 months; history of or currently active
             tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV).

          -  Surgery on the index knee within the previous 6 months.

          -  Trauma or other surgeries within the previous 8 weeks.

          -  Specific abnormal laboratory values or electrocardiogram abnormalities.

          -  Gastrointestinal surgery that may interfere with motility or absorption.

          -  On non-stable dose of bisphosphonates, or any prior denosumab or parathyroid hormone
             (PTH) therapies.

          -  Prior parenteral tumor necrosis factor (TNF) inhibitor or anti-nerve growth factor
             (NGF) therapies.

          -  Intramuscular, intravenous or oral corticosteroids within the previous 6 weeks.

          -  Intra-articular corticosteroids in the index knee within the previous 8 weeks or
             viscosupplementation in the index knee within the previous 4 months.

          -  Currently enrolled in or participated in another clinical trial within the previous 3
             months.

          -  Additional criteria exist.
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? 1