Clinical trial NCT01511549: Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis
Official title: A Randomized, Double-blind, Placebo-controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SAR113945 (IKK Inhibitor) Following Intra-articular Administration in Japanese Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Knee Osteoarthritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 24
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: Primary Objective:

To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Secondary Objective:

To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Detailed description: Following the single dose of study medication, the study period for each patient will be 168 days.

Eligibility criteria: Inclusion criteria:

* Japanese male or female patients, aged 40 years or older, with knee osteoarthritis
* Diagnosis of primary knee osteoarthritis, based upon the following:

  * X-ray or magnetic response imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
  * Patients will be Kellegen and Lawrence classification II or III, and total Western Ontario McMaster (WOMAC) score below or equal to 72
  * Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis

Exclusion criteria:

* Women of child bearing potential
* 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, hemophilia, hemochromatosis, calcium pyrophosphate disposition disease, or neuropathic arthropathy
* Presence of local skin abnormality at the affected knee joint
* Any patient who received intra-articular injection within 3 months prior to administration

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)
timeFrame: up to 24 weeks
measure: Examination of skin/soft tissue of injected knee, and knee joint
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Pharmacokinetic parameter (AUC)
timeFrame: 21 time points up to 24 weeks
measure: Pharmacokinetic parameter (Cmax)
timeFrame: 21 time points up to 24 weeks
measure: Pharmacokinetic parameter (tmax)
timeFrame: 21 time points up to 24 weeks
measure: Pharmacokinetic parameter (t1/2)
timeFrame: 21 time points up to 24 weeks
measure: Pharmacodynamic parameter (WOMAC index)
timeFrame: up to 24 weeks
measure: Pharmacodynamic parameter (biomarkers relating to osteoarthritis)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: