Clinical trial NCT01598415: Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-05-15
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Womac Pain Score (5 items)
timeFrame: at 8 weeks
Secondary outcomes:
measure: Womac Pain Score (5 items)
timeFrame: during 24 weeks
measure: Womac Total Score (24 items)
timeFrame: during 24 weeks
measure: Womac Stiffness (2 items)
timeFrame: during 24 weeks
measure: Womac Physical Function (17 items)
timeFrame: during 24 weeks
measure: synovial fluid levels
timeFrame: during 24 weeks
measure: 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
timeFrame: during 24 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Investigational Site Number 276001
city: München
country: Germany
facility: Investigational Site Number 276002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: