Osteoarthritis
Conditions
Brief summary
Primary Objective: * Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis. Secondary Objective: * Assess systemic exposure of SAR113945 following intra-articular delivery.
Detailed description
The total study duration per subject ranges from 4 to 20 weeks broken down as follows: * screening within 4 weeks before dosing, * follow-up of 4 weeks (28 days) after the single dose of study medication, * prolonged by a maximum of 12 weeks if plasma PK level \> Limit Of Quantification (LOQ) at Day 28.
Interventions
DRUGplacebo
Pharmaceutical form:injection Route of administration: intra-articular
DRUGSAR113945
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
* Male patients or female patients of non child-bearing potential, aged at least 40 years with primary knee osteoarthritis having: * X-ray or Magnetic Resonance Imaging (MRI) evidence for Kellgren Lawrence Grades II./III joint space narrowing and osteophyte formation, * Western Ontario MacMaster (WOMAC) score ≦ 72, * American College of Rheumatology (ACR) Clinical and Radiographic criteria for osteoarthritis.
Exclusion criteria
* Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Principal Investigator, could potentially put the patient at increased risk. * Secondary osteoarthritis. * Moderate/severe renal impairment. * Underlying hepatobiliary disease and/or elevated Alanine Aminotransferase (ALT) \> 3 Upper Limit of Normal range. * Intra-articular injection within 3 months. * Presence of local skin abnormality at the affected knee joint. * Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol or metamizole as analgesic. * Any Investigational Product within 3 months. * Any patient unlikely to comply with the requirements of the study. 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 | Description |
|---|---|---|
| Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis)) | 4 weeks up to a maximum of 12 weeks | — |
| Examination of skin/soft tissue of injected knee | 4 weeks up to a maximum of 12 weeks | Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe. |
| Examination of knee joint of injected knee | 4 weeks up to a maximum of 12 weeks | Any reaction is classified as effusion/worsening of effusion, warm and pain. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters for SAR113945 and potential metabolites(s) from plasma concentration (i.e. AUC, Cmax, tmax, t1/2) | 4 weeks up to a maximum of 16 weeks |
| Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover) | 4 weeks |
Countries
Germany
Outcome results
None listed