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
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 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 July 22, 2014