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Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349956
Recruitment Status : Enrolling by invitation
First Posted : April 16, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Unity Biotechnology, Inc.

Brief Summary:
A follow-up study to assess the long-term safety of intra-articular (IA) administration of UBX0101 in patients with painful knee osteoarthritis (OA).

Condition or disease Intervention/treatment
Knee Osteoarthritis Drug: UBX0101 or placebo

Detailed Description:
This is a blinded, multi-center study to provide approximately 1 additional year of follow-up for patients with knee OA who participated in a randomized placebo-controlled study of IA UBX0101. No intervention is planned and patients will have 4 scheduled visits to collect follow-up assessments. The primary objective is to evaluate long-term safety and tolerability of IA administration of UBX0101 in patients with painful knee OA.

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Study Type : Observational
Estimated Enrollment : 180 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort Intervention/treatment
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.
Drug: UBX0101 or placebo
This is an observational study. No intervention is administered.




Primary Outcome Measures :
  1. Incidence of adverse events up to 1 additional year of follow up. [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Patients with moderate to severe painful knee OA who participated in a randomized, placebo-controlled study of UBX0101 and who consent to having blinded follow-up at the study site for 1 additional year of follow-up. Patients are permitted to take standard-of-care, background medications for OA.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Florida
Well-Pharma Medical Research
Miami, Florida, United States, 33143
Precision Clinical Research
Sunrise, Florida, United States, 33351
Premier Medical Associates
The Villages, Florida, United States, 32159
United States, Kansas
The Alliance for Multispecialty Research
Wichita, Kansas, United States, 67207
United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine
North Charleston, South Carolina, United States, 29406
Sponsors and Collaborators
Unity Biotechnology, Inc.
Investigators
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Study Director: Medical Monitor UNITY Biotechnology
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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: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Biotechnology, Inc.:
Osteoarthritis
Painful Osteoarthritis
Osteoarthritis, Knee
Senescence
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases