Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01511549
First received: January 6, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

Primary Objective:

To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Secondary Objective:

To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses


Condition Intervention Phase
Knee Osteoarthritis
Drug: placebo
Drug: SAR113945
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 Randomized, Double-blind, Placebo-controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SAR113945 (IKK Inhibitor) Following Intra-articular Administration in Japanese Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Examination of skin/soft tissue of injected knee, and knee joint [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]

    Examination of skin/soft tissue of injected knee: Any reaction is classified as erythema, edema, pain, hematoma and graded none, mild, moderate or severe.

    Examination of knee joint of injected knee: Any reaction is classified as effusion/worsening of effusion, warmth and pain.



Secondary Outcome Measures:
  • Pharmacokinetic parameter (AUC) [ Time Frame: 21 time points up to 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (Cmax) [ Time Frame: 21 time points up to 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (tmax) [ Time Frame: 21 time points up to 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter (t1/2) [ Time Frame: 21 time points up to 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameter (WOMAC index) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameter (biomarkers relating to osteoarthritis) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1
SAR113945 low dose
Drug: SAR113945

Pharmaceutical form:injection

Route of administration: intra-articular

Experimental: Dose 2
SAR113945 medium dose
Drug: SAR113945

Pharmaceutical form:injection

Route of administration: intra-articular

Experimental: Dose 3
SAR113945 high dose
Drug: SAR113945

Pharmaceutical form:injection

Route of administration: intra-articular

Placebo Comparator: Placebo
Placebo
Drug: placebo

Pharmaceutical form:injection

Route of administration: intra-articular


Detailed Description:

Following the single dose of study medication, the study period for each patient will be 168 days.

  Eligibility

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

Inclusion criteria:

  • Japanese male or female patients, aged 40 years or older, with knee osteoarthritis
  • Diagnosis of primary knee osteoarthritis, based upon the following:

    • X-ray or magnetic response imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
    • Patients will be Kellegen and Lawrence classification II or III, and total Western Ontario McMaster (WOMAC) score below or equal to 72
    • Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis

Exclusion criteria:

  • Women of child bearing potential
  • 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, hemophilia, hemochromatosis, calcium pyrophosphate disposition disease, or neuropathic arthropathy
  • Presence of local skin abnormality at the affected knee joint
  • Any patient who received intra-articular injection within 3 months prior to administration

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 ClinicalTrials.gov identifier: NCT01511549

Locations
Japan
Investigational Site Number 392001
Osaka-Shi, Japan, 532-0003
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01511549     History of Changes
Other Study ID Numbers: TDU11333, U1111-1121-4499
Study First Received: January 6, 2012
Last Updated: September 28, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014