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

Completed · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT02951026

Run by

Biosplice Therapeutics, Inc.

People needed

703

Starts

2016-09-19

Expected to finish

2019-10-31

Last updated by the study team

2020-04-17

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Oro Valley, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Canoga Park, California, United States
• Research Site — Carmichael, California, United States
• Research Site — Cerritos, California, United States
• Research Site — El Cajon, California, United States
• Research Site — Gold River, California, United States
• Research Site — La Mesa, California, United States
• Research Site — Palm Springs, California, United States
• Research Site — Rancho Mirage, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Marcos, California, United States
• Research Site — Spring Valley, California, United States
• Research Site — Boulder, Colorado, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Trumbull, Connecticut, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Edgewater, Florida, United States
• Research Site — Lauderdale Lakes, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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