Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: October 29, 2011
Last updated: August 22, 2012
Last verified: August 2012

Study objectives:

  • Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.
  • Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Two Part Protocol to Assess, Using Double Blind Placebo Control, the Safety, Tolerability, and Pharmacokinetics of Ascending Single Doses of a New Intra-articular Administration Formulation of SAR113945 (IKK Inhibitor) Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose in Patients With Knee Osteoarthritis

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pain, Stiffness and Physical Function sub-scales from the WOMAC Index [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]
  • Number of patients reporting Adverse Events of special interest: tolerability at the site of injection and in the knee + other events reported by the patient [ Time Frame: during 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (Cmax) [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics (AUC) [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics (t1/2) [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]
  • synovial fluid levels [ Time Frame: during 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR113945 - Dose 1 Drug: SAR113945

Pharmaceutical form:Injection

Route of administration: Intra-articular

Experimental: SAR113945 - Dose 2 Drug: SAR113945

Pharmaceutical form:Injection

Route of administration: Intra-articular

Experimental: SAR113945 - Dose 3 Drug: SAR113945

Pharmaceutical form:Injection

Route of administration: Intra-articular

Placebo Comparator: Placebo Drug: placebo

Pharmaceutical form:Injection

Route of administration: Intra-articular

Detailed Description:

- Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 168 days.


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

- Diagnosis of primary knee osteoarthritis, based upon the following:

  • X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
  • Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72.
  • Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis.

Exclusion criteria:

  • Patients younger than 40 years
  • Women of child bearing potential.
  • Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level >30 IU/L.
  • Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
  • Presence of local skin abnormality at the affected knee joint.
  • Intra-articular injection within 3 months.

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

  Contacts and Locations
Please refer to this study by its identifier: NCT01463488

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

No publications provided

Responsible Party: Sanofi Identifier: NCT01463488     History of Changes
Other Study ID Numbers: TDU11685, 2011-003232-31, U1111-1121-3831, TDU11685/ACT12505
Study First Received: October 29, 2011
Last Updated: August 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on April 17, 2014