Knee OsteoarthritisNCT04349956
Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo
An observational study of Knee Osteoarthritis, run by Unity Biotechnology, Inc. at 17 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 17 sitesUnited States
- Study dates
- 20 Apr 2020to 2 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Hassman Research Institute
Berlin, New Jersey, 08009
Chicago Clinical Research Institute
Chicago, Illinois, 60607
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Drug Trials America
Hartsdale, New York, 10530
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Biosolutions Clinical Research Center
La Mesa, California, 91942
Well-Pharma Medical Research
Miami, Florida, 33143
Coastal Clinical Research, LLC.
Mobile, Alabama, 36608
Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine
North Charleston, South Carolina, 29406
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Precision Clinical Research
Sunrise, Florida, 33351
Fiel Family and Sports Medicine
Tempe, Arizona, 85283
Premier Medical Associates
The Villages, Florida, 32159
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Diablo Clinical Research
Walnut Creek, California, 94598
The Alliance for Multispecialty Research
Wichita, Kansas, 67207
About this study
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
A follow-up study to assess the long-term safety of intra-articular (IA) administration of UBX0101 in patients with painful knee osteoarthritis (OA).
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- UBX0101 or placebo
- Keywords
- Osteoarthritis, Painful Osteoarthritis, Osteoarthritis, Knee, Senescence
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBX0101 or placeboDrug
This is an observational study. No intervention is administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: UBX0101 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events up to 1 additional year of follow up.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start20 Apr 2020
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Why it stopped: Inability to achieve primary or secondary study objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, UNITY Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349956
- Sponsor's protocol ID
- UBX0101-05
- Status last verified
- Nov 2020
- First submitted
- 13 Apr 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04349956
- Acronym / sponsor ID
- UBX0101-05
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Painful Osteoarthritis, Osteoarthritis, Knee, Senescence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inability to achieve primary or secondary study objectives
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Unity Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients from a randomized placebo-controlled study of UBX0101 | – | Drug: UBX0101 or placeboPatients with moderate to severe, painful OA of the knee who participated in a randomized, placebo-controlled study of UBX0101. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UBX0101 or placeboThis is an observational study. No intervention is administered. | Drug | Patients from a randomized placebo-controlled study of UBX0101 |
Primary outcome
Incidence of adverse events up to 1 additional year of follow up.
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: Inability to achieve primary or secondary study objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
UNITY Biotechnology
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Unity Biotechnology, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to achieve primary or secondary study objectives). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events up to 1 additional year of follow up. (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.