Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis

Sanofi

Status and phase: Completed; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Drug: placebo; Drug: SAR113945

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511549

U1111-1121-4499 (Other Identifier)

TDU11333

Details and patient eligibility

About

Primary Objective:

To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Secondary Objective:

To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Full description

Following the single dose of study medication, the study period for each patient will be 168 days.

Enrollment: 24 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese male or female patients, aged 40 years or older, with knee osteoarthritis

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

  • X-ray or magnetic response imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
  • Patients will be Kellegen and Lawrence classification II or III, and total Western Ontario McMaster (WOMAC) score below or equal to 72
  • Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis

Exclusion criteria

• Women of child bearing potential
• 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, hemophilia, hemochromatosis, calcium pyrophosphate disposition disease, or neuropathic arthropathy
• Presence of local skin abnormality at the affected knee joint
• Any patient who received intra-articular injection within 3 months prior to administration

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

Dose 1

Experimental group

Description:

SAR113945 low dose

Treatment:

Drug: SAR113945

Dose 2

Experimental group

Description:

SAR113945 medium dose

Treatment:

Drug: SAR113945

Dose 3

Experimental group

Description:

SAR113945 high dose

Treatment:

Drug: SAR113945

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo