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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: SAR113945; Drug: placebo

• Registration Number: NCT01113333
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAR113945	SAR113945	SAR113945, single dose according to dose escalation design
Placebo	placebo	0.9% saline solution, single dose

Primary Outcome Measures

Name	Time	Method
Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))	4 weeks up to a maximum of 12 weeks
Examination of skin/soft tissue of injected knee	4 weeks up to a maximum of 12 weeks	Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.
Examination of knee joint of injected knee	4 weeks up to a maximum of 12 weeks	Any reaction is classified as effusion/worsening of effusion, warm and pain.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters for SAR113945 and potential metabolites(s) from plasma concentration (i.e. AUC, Cmax, tmax, t1/2)	4 weeks up to a maximum of 16 weeks
Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover)	4 weeks

Trial Locations

Locations (1)

Sanofi-Aventis Investigational Site Number 276001; 🇩🇪 Berlin, Germany