Knee Osteoarthritis
Conditions
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.
Interventions
DRUGSAR113945
Pharmaceutical form:Injection Route of administration: Intra-articular
DRUGplacebo
Pharmaceutical form:Injection Route of administration: Intra-articular
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Womac Pain Score (5 items) | at 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Womac Total Score (24 items) | during 24 weeks |
| Womac Stiffness (2 items) | during 24 weeks |
| Womac Pain Score (5 items) | during 24 weeks |
| synovial fluid levels | 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 | during 24 weeks |
| Womac Physical Function (17 items) | during 24 weeks |
Countries
Germany
Outcome results
None listed