This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: April 23, 2010
Last updated: March 22, 2011
Last verified: March 2011

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.

Condition Intervention Phase
Osteoarthritis Drug: placebo Drug: SAR113945 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

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)) [ Time Frame: 4 weeks up to a maximum of 12 weeks ]
  • Examination of skin/soft tissue of injected knee [ Time Frame: 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 [ Time Frame: 4 weeks up to a maximum of 12 weeks ]
    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) [ Time Frame: 4 weeks up to a maximum of 16 weeks ]
  • Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover) [ Time Frame: 4 weeks ]

Estimated Enrollment: 40
Study Start Date: April 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR113945
SAR113945, single dose according to dose escalation design
Drug: SAR113945

Pharmaceutical form:injection

Route of administration: intra-articular

Placebo Comparator: Placebo
0.9% saline solution, single dose
Drug: placebo

Pharmaceutical form:injection

Route of administration: intra-articular

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.

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01113333

Sanofi-Aventis Investigational Site Number 276001
Berlin, Germany, 14050
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT01113333     History of Changes
Other Study ID Numbers: TDU10820
2009-017502-36 ( EudraCT Number )
U1111-1116-5630 ( Other Identifier: UTN )
Study First Received: April 23, 2010
Last Updated: March 22, 2011

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on September 18, 2017