Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01113333 | Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis | PHASE1 | COMPLETED | 40 | — | — | Apr 1, 2010 | Feb 1, 2011 | Mar 23, 2011 | 1 | Germany |
Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.
Any reaction is classified as effusion/worsening of effusion, warm and pain.
| Arm | Type | Description |
|---|---|---|
| SAR113945 | EXPERIMENTAL | SAR113945, single dose according to dose escalation design |
| Placebo | PLACEBO_COMPARATOR | 0.9% saline solution, single dose |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | Pharmaceutical form:injection Route of administration: intra-articular |
| SAR113945 | DRUG | Pharmaceutical form:injection Route of administration: intra-articular |
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, * Wes...