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.

• Conditions: KNEE OSTEOARTHRITIS; MedDRA version: 14.0Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-003232-31-DE
• Lead Sponsor: sanofi-aventis recherche et développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-29
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 77
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 77

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified