NCT02951026

An Observational 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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 703 (actual)
• Sponsor: Biosplice Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
OTHER	Not 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.

Timeline

• Start date: 2016-09-19
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2016-11-01
• Last updated: 2020-04-17

Locations

62 sites across 1 country: United States