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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Knee Osteoarthritis

Treatments

Drug: placebo

Drug: SAR113945

Study type

Interventional

Funder types

Industry

Identifiers

TDU11685/ACT12505 (Other Identifier)

U1111-1124-5323 (Other Identifier)

ACT12505

2011-003232-31 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 168 days.

Enrollment

130 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.