Study Stopped
Inability to achieve primary or secondary study objectives
Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo
1 other identifier
observational
161
1 country
17
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedStudy Start
First participant enrolled
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2020
CompletedNovember 17, 2020
November 1, 2020
7 months
April 13, 2020
November 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events up to 1 additional year of follow up.
52 weeks
Study Arms (1)
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.
Interventions
This is an observational study. No intervention is administered.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Coastal Clinical Research, LLC.
Mobile, Alabama, 36608, United States
Fiel Family and Sports Medicine
Tempe, Arizona, 85283, United States
Tucson Orthopaedic Institute
Tucson, Arizona, 85712, United States
Biosolutions Clinical Research Center
La Mesa, California, 91942, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Well-Pharma Medical Research
Miami, Florida, 33143, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Premier Medical Associates
The Villages, Florida, 32159, United States
Chicago Clinical Research Institute
Chicago, Illinois, 60607, United States
The Alliance for Multispecialty Research
Wichita, Kansas, 67207, United States
Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Drug Trials America
Hartsdale, New York, 10530, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine
North Charleston, South Carolina, 29406, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
UNITY Biotechnology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2020
First Posted
April 16, 2020
Study Start
April 20, 2020
Primary Completion
November 2, 2020
Study Completion
November 2, 2020
Last Updated
November 17, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share