Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SD-6010 · 1 trial · 1 indication
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...
SD-6010 is an investigational small molecule being developed for osteoarthritis, specifically osteoarthritis of the knee. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.
SD-6010 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with osteoarthritis.
SD-6010 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. One Phase 2 trial has been completed, and no active trials are currently listed.
SD-6010 has one completed Phase 2 clinical trial, identified as NCT00565812. This was a long-term, placebo-controlled X-ray study investigating the safety and efficacy of SD-6010 in subjects with osteoarthritis of the knee, enrolling 1,457 participants.
SD-6010 is the primary name used in clinical trials and development. No alternative names have been reported for this drug, so it is not known to be the same as any other marketed or investigational medication.