Clinical trial: Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I (NCT01463488)

Eligibility criteria:
Inclusion criteria:

        - Diagnosis of primary knee osteoarthritis, based upon the following:

          -  X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint
             space narrowing and osteophyte formation

          -  Patients will be Kellgren and Lawrence classification II/III, and total Western
             Ontario McMaster (WOMAC) score 24 -72.

          -  Patients fulfilling the American College of Rheumatology Clinical and Radiographic
             criteria for Osteoarthritis.

        Exclusion criteria:

          -  Patients younger than 40 years

          -  Women of child bearing potential.

          -  Women either sterilized for more than 3 months, or post-menopausal for more than 12
             months. Menopause is defined as over age of 60 years or being amenorrheic for at least
             2 years with plasma FSH level >30 IU/L.

          -  Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic
             osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease,
             Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium
             pyrophosphate deposition disease, or neuropathic arthropathy.

          -  Presence of local skin abnormality at the affected knee joint.

          -  Intra-articular injection within 3 months.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
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