Clinical trial NCT04349956: Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Painful Osteoarthritis
Osteoarthritis, Knee
Senescence
Lead sponsor: Unity Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 161
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of adverse events up to 1 additional year of follow up.
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, LLC.
state: Alabama
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: La Mesa
country: United States
facility: Biosolutions Clinical Research Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Miami
country: United States
facility: Well-Pharma Medical Research
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: The Villages
country: United States
facility: Premier Medical Associates
state: Florida
city: Chicago
country: United States
facility: Chicago Clinical Research Institute
state: Illinois
city: Wichita
country: United States
facility: The Alliance for Multispecialty Research
state: Kansas
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: North Charleston
country: United States
facility: Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine
state: South Carolina
Study officials:
affiliation: UNITY Biotechnology
name: Medical Monitor
role: STUDY_DIRECTOR
References: