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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:
ClinicalTrials.gov Identifier:
NCT01463488
First Posted: November 2, 2011
Last Update Posted: August 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • 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 ]

Secondary Outcome Measures:
  • Pharmacokinetics (Cmax) [ Time Frame: during 24 weeks ]
  • Pharmacokinetics (AUC) [ Time Frame: during 24 weeks ]
  • Pharmacokinetics (t1/2) [ Time Frame: during 24 weeks ]
  • synovial fluid levels [ Time Frame: during 24 weeks ]

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463488


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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01463488     History of Changes
Other Study ID Numbers: TDU11685
2011-003232-31 ( EudraCT Number )
U1111-1121-3831 ( Other Identifier: UTN )
TDU11685/ACT12505 ( Other Identifier: sanofi-aventis other study code )
First Submitted: October 29, 2011
First Posted: November 2, 2011
Last Update Posted: August 23, 2012
Last Verified: August 2012

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