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



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - 80
Updated:4/6/2019
Start Date:September 2016
End Date:May 2023

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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

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.


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
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62
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Charleston, South Carolina 29412
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Charlotte, North Carolina 28207
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Duncansville, Pennsylvania 16635
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Lauderdale Lakes, Florida 33313
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Mount Pleasant, South Carolina 29464
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Newton, KS
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Rancho Mirage, California 90070
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Salisbury, North Carolina 28144
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Spring Valley, California 91978
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