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
  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
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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: NCT01463488

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov 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
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014