Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo
- Conditions
- Knee Osteoarthritis
- Interventions
- Drug: UBX0101 or placebo
- Registration Number
- NCT04349956
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 161
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients from a randomized placebo-controlled study of UBX0101 UBX0101 or placebo Patients with moderate to severe, painful OA of the knee who participated in a randomized, placebo-controlled study of UBX0101.
- Primary Outcome Measures
Name Time Method Incidence of adverse events up to 1 additional year of follow up. 52 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Coastal Clinical Research, LLC.
🇺🇸Mobile, Alabama, United States
Fiel Family and Sports Medicine
🇺🇸Tempe, Arizona, United States
Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine
🇺🇸North Charleston, South Carolina, United States
Tucson Orthopaedic Institute
🇺🇸Tucson, Arizona, United States
Biosolutions Clinical Research Center
🇺🇸La Mesa, California, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Well-Pharma Medical Research
🇺🇸Miami, Florida, United States
Premier Medical Associates
🇺🇸The Villages, Florida, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
The Alliance for Multispecialty Research
🇺🇸Wichita, Kansas, United States
Chicago Clinical Research Institute
🇺🇸Chicago, Illinois, United States