Clinical trial: A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee (NCT03956550)

Eligibility criteria:
Key Inclusion Criteria:

          -  Generally in good health at the screening visit

          -  Body mass index (BMI) ≤39 kg/m2 at the screening visit

          -  Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria
             (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the
             screening visit

          -  Moderate-to-severe pain in the index joint

          -  A history of inadequate pain relief from or intolerance to analgesics used for OA

        Key Exclusion Criteria:

          -  Diagnosis of systemic diseases that may affect joints

          -  History or presence of osteonecrosis, destructive arthropathy, neuropathic joint
             arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip
             dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella
             dislocation is eligible) at the screening visit. Presence of subchondral insufficiency
             fracture on screening films or MRI as assessed by the central imaging reader.

          -  Is scheduled for a joint replacement surgery to be performed during the study period

          -  Received an intra-articular injection of hyaluronic acid in any joint within 90 days
             prior to the screening visit

          -  Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the
             screening visit. Intra-articular corticosteroids in the index joint within 12 weeks
             prior to the screening visit, or to any other joint within 30 days prior to the
             screening visit (topical, intranasal, or inhaled corticosteroids are permitted).

          -  History or presence at the screening visit of multiple sclerosis, autonomic
             neuropathy, diabetic neuropathy, or other peripheral neuropathy

          -  Significant concomitant illness including, but not limited to, psychiatric, cardiac,
             renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that,
             in the opinion of the investigator, would adversely affect the patient's participation
             in the study

          -  History of myocardial infarction, acute coronary syndromes, transient ischemic attack,
             or cerebrovascular accident within 12 months prior to the screening visit

        Note: Other protocol defined inclusion/exclusion criteria apply.
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.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment