Osteoarthritis
Conditions
Keywords
knee, osteoarthritis, intra-articular injection, SM04690
Brief summary
This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be administered in this study.
Interventions
OTHERNot applicable (no therapy is administered as part of this study)
No experimental therapy or placebo is being administered in this study. All subjects in this observational study received a single intra-articular injection of SM04690 or placebo in a prior parent study.
Sponsors
Biosplice Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Completion of scheduled end-of-study visit of Samumed-sponsored SM04690-OA phase 2 or phase 3 studies * Full understanding of the requirements of the study and willingness to comply with all study visits and assessments * Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
Exclusion criteria
* Unable to undergo the radiograph procedures detailed within the protocol * Partial or complete joint replacement in the target knee * Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site * Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of serious adverse events (SAEs) | Month 60 | Compare the incidence rate of SAEs occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AEs of interest | Month 12 | Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 12. |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score | Baseline and Month 6 | Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. |
| Incidence and incidence rate of total knee replacement (TKR) | Month 60 | Compare the incidence and incidence rate of TKR in the previously injected knee occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60. |
| Change in joint space width (JSW) | Baseline and Month 6 | Change from baseline in JSW as documented by X-ray of the target knee in both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. |
| Adverse events (AEs) of interest | Month 6 | Compare the number of subjects who experience an AE of interest occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm at Month 6. AEs of interest include those related to either knee and/or an AE that is a newly diagnosed chronic condition requiring treatment (e.g., hypertension, hyperlipidemia, diabetes). |
| Change in WOMAC pain subscore | Baseline and Month 6 | Change from baseline in WOMAC pain subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. |
| Change in WOMAC function subscore | Baseline and Month 6 | Change from baseline in WOMAC function subscore for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. |
| Change in Physician Global Assessment | Baseline and Month 6 | Change from baseline OA disease activity as assessed by Physician Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. |
| Change in Patient Global Assessment | Baseline and Month 6 | Change from baseline OA disease activity as assessed by Patient Global Assessment for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 6. |
| Change in WOMAC total score | Baseline and Month 12 | Change from baseline in WOMAC total score for the target knee for both the (previously injected) SM04690 treatment arms and the (previously injected) placebo treatment arm at Month 12. |
Countries
United States
Outcome results
None listed