A Phase 3, Multicenter, Observational Long-term Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis

Biosplice Therapeutics, Inc.1 site in 1 country703 target enrollmentSeptember 19, 2016

ConditionsOsteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Biosplice Therapeutics, Inc.
Enrollment: 703
Locations: 1
Primary Endpoint: Incidence rate of serious adverse events (SAEs)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 19, 2016

End Date

October 31, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Biosplice Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence rate of serious adverse events (SAEs)

Time Frame: 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 Outcomes

Incidence and incidence rate of total knee replacement (TKR)(Month 60)
Adverse events (AEs) of interest(Month 6)
AEs of interest(Month 60)
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score(Baseline and Month 6)
Change in joint space width (JSW)(Baseline and Month 60)
Change in WOMAC total score(Baseline and Month 60)
Change in WOMAC function subscore(Baseline and Month 60)
Change in WOMAC pain subscore(Baseline and Month 60)
Change in Physician Global Assessment(Baseline and Month 60)
Change in Patient Global Assessment(Baseline and Month 60)