Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo
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ClinicalTrials.gov Identifier: NCT04349956 |
Recruitment Status :
Terminated
(Inability to achieve primary or secondary study objectives)
First Posted : April 16, 2020
Last Update Posted : November 17, 2020
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Condition or disease | Intervention/treatment |
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Knee Osteoarthritis | Drug: UBX0101 or placebo |
Study Type : | Observational |
Actual Enrollment : | 161 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Long-Term Follow-Up Study of Patients With Moderate to Severe, Painful Osteoarthritis of the Knee Who Participated in a Randomized, Placebo-Controlled Study of UBX0101 |
Actual Study Start Date : | April 20, 2020 |
Actual Primary Completion Date : | November 2, 2020 |
Actual Study Completion Date : | November 2, 2020 |
Group/Cohort | Intervention/treatment |
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Patients from a randomized placebo-controlled study of UBX0101
Patients with moderate to severe, painful OA of the knee who participated in a randomized, placebo-controlled study of UBX0101.
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Drug: UBX0101 or placebo
This is an observational study. No intervention is administered. |
- Incidence of adverse events up to 1 additional year of follow up. [ Time Frame: 52 weeks ]
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Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with knee OA who have completed a randomized placebo-controlled study of UBX0101.
- Patients who are willing and able to consent to having blinded, long-term follow-up; consent via legally authorized representative is not accepted.
Exclusion Criteria:
- Patients with any condition that, in the opinion of the Investigator, would likely interfere with adhering to the study schedule of visits for 12 months.
- Patients who are scheduled to undergo knee arthroplasty on either knee during the study.
- Patients who anticipate arthroscopic surgery on either knee at any time during the study.
- Patients who plan to receive treatment with an anti-nerve growth factor agent during the study.
- Patients who plan to participate in another investigational study (including interventional studies of investigational drugs and investigational treatments [e.g., braces, stem cells, and procedures]) during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349956
Study Director: | Medical Monitor | UNITY Biotechnology |
Responsible Party: | Unity Biotechnology, Inc. |
ClinicalTrials.gov Identifier: | NCT04349956 |
Other Study ID Numbers: |
UBX0101-05 |
First Posted: | April 16, 2020 Key Record Dates |
Last Update Posted: | November 17, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Painful Osteoarthritis Osteoarthritis, Knee Senescence |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |