A two part protocol to assess, using double blind placebo control, the safety, tolerability, and pharmacokinetics of ascending single doses of a new intra-articular administration formulation of SAR113945 (IKK inhibitor) followed by assessment of efficacy, safety, tolerability and pharmacokinetics of a single dose in patients with knee osteoarthritis.

sanofi-aventis recherche et développement0 sitesStarted: September 29, 2011Last updated: May 12, 2014

Overview

No summary available.

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 77
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 77

•\- 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.

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