Back to results

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

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

placebo

SAR113945

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Investigational Site Number 276001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR113945

Placebo

Arm Description

SAR113945, single dose according to dose escalation design

0.9% saline solution, single dose

Outcomes

Primary Outcome Measures

Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))

Examination of skin/soft tissue of injected knee

Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.

Examination of knee joint of injected knee

Any reaction is classified as effusion/worsening of effusion, warm and pain.

Secondary Outcome Measures

Pharmacokinetic parameters for SAR113945 and potential metabolites(s) from plasma concentration (i.e. AUC, Cmax, tmax, t1/2)

Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover)

Full Information

NCT ID

NCT01113333

First Posted

April 23, 2010

Last Updated

March 22, 2011

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01113333

Brief Title

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

Official Title

A Double Blind, Placebo Controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the IKK Inhibitor, SAR113945, Following Intra-articular Administration in Patients With Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SAR113945

Arm Type

Experimental

Arm Description

SAR113945, single dose according to dose escalation design

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.9% saline solution, single dose

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Pharmaceutical form:injection Route of administration: intra-articular

Intervention Type

Drug

Intervention Name(s)

SAR113945

Intervention Description

Pharmaceutical form:injection Route of administration: intra-articular

Primary Outcome Measure Information:

Title

Time Frame

4 weeks up to a maximum of 12 weeks

Title

Examination of skin/soft tissue of injected knee

Description

Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.

Time Frame

4 weeks up to a maximum of 12 weeks

Title

Examination of knee joint of injected knee

Description

Any reaction is classified as effusion/worsening of effusion, warm and pain.

Time Frame

4 weeks up to a maximum of 12 weeks

Secondary Outcome Measure Information:

Title

Pharmacokinetic parameters for SAR113945 and potential metabolites(s) from plasma concentration (i.e. AUC, Cmax, tmax, t1/2)

Time Frame

4 weeks up to a maximum of 16 weeks

Title

Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover)

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Investigational Site Number 276001

City

Berlin

ZIP/Postal Code

14050

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs