NCT01113333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

10 months

First QC Date

April 23, 2010

Last Update Submit

March 22, 2011

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • 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

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

    4 weeks up to a maximum of 12 weeks

  • Examination of knee joint of injected knee

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

    4 weeks up to a maximum of 12 weeks

Secondary Outcomes (2)

  • 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

Study Arms (2)

SAR113945

EXPERIMENTAL

SAR113945, single dose according to dose escalation design

Drug: SAR113945

Placebo

PLACEBO COMPARATOR

0.9% saline solution, single dose

Drug: placebo

Interventions

placeboDRUG

Pharmaceutical form:injection Route of administration: intra-articular

Placebo
SAR113945DRUG

Pharmaceutical form:injection Route of administration: intra-articular

SAR113945

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Investigational Site Number 276001

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 29, 2010

Study Start

April 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations

DE(1)