Clinical trial: Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip (NCT02447276)

Eligibility criteria:
Key Inclusion Criteria:

          1. Body mass index ≤39

          2. Clinical diagnosis of OA of the knee or hip

          3. History of inadequate pain relief or intolerance to analgesics used for OA

          4. Moderate to severe pain in the index joint

          5. History of regular use of analgesic medications for OA pain

          6. Willing to discontinue current non-steroidal anti-inflammatory drug (NSAID) and opioid
             pain medications

        Key Exclusion Criteria:

          1. Other diseases that may involve index knee or hip, including inflammatory joint
             diseases, crystalline disease (gout or pseudogout), endocrinopathies, metabolic joint
             disease, lupus erythematosus, rheumatoid arthritis, joint infections, neuropathic
             disorders, avascular necrosis, Paget's disease, renal osteodystrophy or tumors

          2. History of osteonecrosis, destructive arthropathy (RPOA), hip dislocation, pathologic
             fractures, neuropathic joint arthropathy, knee dislocation or hip dislocation

          3. Trauma to the index joint in the 30 days before screening

          4. Active fibromyalgia, regional pain caused by lumbar or cervical compression with
             radiculopathy or other moderate to severe pain that may confound assessments or
             self-evaluation of the pain associated with OA

          5. Prior to the start of the study has received a recommendation for, or is scheduled for
             joint replacement surgery to be performed during the study period

          6. Presence of subchondral insufficiency fracture on screening films or MRI

          7. Received an intra-articular injection of hyaluronic acid in the affected index joint
             within 90 days prior to the screening visit

          8. Systemic (ie, oral or intramuscular) corticosteroids within 30 days prior to the
             screening visit. Intra-articular corticosteroids in the index joint within 12 weeks of
             the screening visit, or to any other joint within 30 days prior to the screening
             visit.

          9. History of autonomic neuropathy, diabetic neuropathy, or presence of clinically
             relevant peripheral neuropathy at the time of screening

         10. Women of childbearing potential who have a positive pregnancy test result, or who do
             not have their pregnancy test results at baseline

         11. Pregnant or breastfeeding women
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 80 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