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
NCT ID: NCT02951026
Last Updated: 2020-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
703 participants
OBSERVATIONAL
2016-09-19
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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0.03mg SM04690 (previously injected)
Subjects in this group received a single intra-articular injection of 0.03mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.
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.
0.07mg SM04690 (previously injected)
Subjects in this group received a single intra-articular injection of 0.07mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.
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.
0.23mg SM04690 (previously injected)
Subjects in this group received a single intra-articular injection of 0.23mg SM04690 into the target knee during the "parent" study prior to enrolling in this observational study.
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.
Placebo (previously injected)
Subjects in this group received a single intra-articular injection of placebo into the target knee during the "parent" study prior to enrolling in this observational study.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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Biosplice Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yusuf Yazici, M.D.
Role: STUDY_DIRECTOR
Biosplice Therapeutics, Inc.
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Oro Valley, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Canoga Park, California, United States
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Carmichael, California, United States
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Cerritos, California, United States
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El Cajon, California, United States
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Gold River, California, United States
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La Mesa, California, United States
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Palm Springs, California, United States
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Rancho Mirage, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Marcos, California, United States
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Spring Valley, California, United States
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Boulder, Colorado, United States
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Stamford, Connecticut, United States
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Trumbull, Connecticut, United States
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Waterbury, Connecticut, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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DeLand, Florida, United States
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Edgewater, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Marietta, Georgia, United States
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Woodstock, Georgia, United States
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Chicago, Illinois, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Frederick, Maryland, United States
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Boston, Massachusetts, United States
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Troy, Michigan, United States
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City of Saint Peters, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Orchard Park, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Duncansville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Rapid City, South Dakota, United States
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Knoxville, Tennessee, United States
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Austin, Texas, United States
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Bedford, Texas, United States
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Houston, Texas, United States
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San Angelo, Texas, United States
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Layton, Utah, United States
Research Site
Arlington, Virginia, United States
Research Site
Charlottesville, Virginia, United States
Countries
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References
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Swearingen CJ, Tambiah JRS, Simsek I, Ghandehari H, Kennedy S, Yazici Y. Evaluation of Safety and Efficacy of a Single Lorecivivint Injection in Patients with Knee Osteoarthritis: A Multicenter, Observational Extension Trial. Rheumatol Ther. 2025 Feb;12(1):157-171. doi: 10.1007/s40744-024-00731-9. Epub 2025 Jan 4.
Other Identifiers
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SM04690-OA-05
Identifier Type: -
Identifier Source: org_study_id
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