Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II

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.