Overview

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

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
0
Participant gender:
All
Summary
Study objectives: - Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945. - Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
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.