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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00565812 | A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee | PHASE2 | COMPLETED | 1,457 | — | — | Nov 1, 2007 | Nov 1, 2011 | Dec 30, 2016 | 183 | United States, Argentina +12 |
Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.
Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
| Arm | Type | Description |
|---|---|---|
| 200 mg | ACTIVE_COMPARATOR | High dose active comparator |
| 50 mg | ACTIVE_COMPARATOR | Low dose active comparator |
| Placebo | PLACEBO_COMPARATOR | Placebo comparator to be used for control purposes |
| Name | Type | Description |
|---|---|---|
| SD-6010 | DRUG | 200 mg tablets once a day for 2 years |
| Placebo | DRUG | Placebo tablets once a day for 2 years |
Inclusion Criteria: * Subjects aged \>= 40 years with a BMI \>= 25 and \<= 40 kg/m2 * In the past, has been diagnosed with knee OA * Radiographic evidence of OA in the study knee Exclusion Criteria: * A diagnosis of any other rheumatic disease * Current conditions in the study knee that would con...