Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis

NCT ID: NCT01113333

Last Updated: 2011-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-02-28

Brief Summary

Primary Objective:

• Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.

Secondary Objective:

• Assess systemic exposure of SAR113945 following intra-articular delivery.

Detailed Description

The total study duration per subject ranges from 4 to 20 weeks broken down as follows:

• screening within 4 weeks before dosing,
• follow-up of 4 weeks (28 days) after the single dose of study medication,
• prolonged by a maximum of 12 weeks if plasma PK level > Limit Of Quantification (LOQ) at Day 28.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAR113945

SAR113945, single dose according to dose escalation design

Group Type: EXPERIMENTAL

SAR113945

Intervention Type: DRUG

Pharmaceutical form:injection

Route of administration: intra-articular

Placebo

0.9% saline solution, single dose

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Pharmaceutical form:injection

Route of administration: intra-articular

Interventions

placebo

Pharmaceutical form:injection

Route of administration: intra-articular

Intervention Type: DRUG

SAR113945

Pharmaceutical form:injection

Route of administration: intra-articular

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male patients or female patients of non child-bearing potential, aged at least 40 years with primary knee osteoarthritis having:

• X-ray or Magnetic Resonance Imaging (MRI) evidence for Kellgren Lawrence Grades II./III joint space narrowing and osteophyte formation,
• Western Ontario MacMaster (WOMAC) score ≦ 72,
• American College of Rheumatology (ACR) Clinical and Radiographic criteria for osteoarthritis.

Exclusion Criteria

• Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Principal Investigator, could potentially put the patient at increased risk.
• Secondary osteoarthritis.
• Moderate/severe renal impairment.
• Underlying hepatobiliary disease and/or elevated Alanine Aminotransferase (ALT) > 3 Upper Limit of Normal range.
• Intra-articular injection within 3 months.
• Presence of local skin abnormality at the affected knee joint.
• Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol or metamizole as analgesic.
• Any Investigational Product within 3 months.
• Any patient unlikely to comply with the requirements of the study.

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Investigational Site Number 276001

Berlin, , Germany

Countries

Germany

Other Identifiers

2009-017502-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1116-5630

Identifier Type: OTHER

Identifier Source: secondary_id

TDU10820

Identifier Type: -

Identifier Source: org_study_id