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.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01463488
First received: October 29, 2011
Last updated: August 22, 2012
Last verified: August 2012

October 29, 2011
August 22, 2012
November 2011
August 2012   (final data collection date for primary outcome measure)
  • 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 ]
Womac Pain Score (5 items) [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01463488 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Womac Total Score (24 items) [ Time Frame: at 8, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Womac Stiffness (2 items) [ Time Frame: at 8, 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Womac Physical Function (17 items) [ Time Frame: at 8, 12 and 24 week ] [ Designated as safety issue: No ]
  • 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 ]
  • Pharmacokinetics (synovial fluid levels) [ 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 ]
Not Provided
Not Provided
 
Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I
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

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.

- 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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Drug: SAR113945

    Pharmaceutical form:Injection

    Route of administration: Intra-articular

  • Drug: placebo

    Pharmaceutical form:Injection

    Route of administration: Intra-articular

  • Experimental: SAR113945 - Dose 1
    Intervention: Drug: SAR113945
  • Experimental: SAR113945 - Dose 2
    Intervention: Drug: SAR113945
  • Experimental: SAR113945 - Dose 3
    Intervention: Drug: SAR113945
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2012
August 2012   (final data collection date for primary outcome measure)

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.

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01463488
TDU11685, 2011-003232-31, U1111-1121-3831, TDU11685/ACT12505
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP