OsteoarthritisNCT03412864
A Post Marketing Surveillance Study of INVOSSA K Inj.
An observational study of Osteoarthritis, run by Kolon Life Science at 1 site in South Korea.
Trial summary
This study is post-marketing surveillance of Invossa K injection in patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2017to 11 Jul 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients over 19 years with osteoarthritis
Who may be able to join
- Male or female patients over 19 years
- Patients who diagnosed with osteoarthritis will plan to INVOSSA K Inj. injection and suitable for following criteria :
- Moderate knee osteoarthritis (Kellgren \& Lawrence grade 3) with persistent symptoms (pain, etc.) in spite of conservative therapy (medication, physical therapy, etc.) for more than 3 months
- Patients (or substitute) who is provided all information regarding participation of this PMS signed the informed consent form
Who cannot join
- Pregnant or breastfeeding female
- Patients who have administered corticosteroid before INVOSSA K Inj. injection within the past 30 days
- Patients who have severe disease such as heart, liver, kidney disease or other severe complications
- Patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis
- Patients with a medical history of allergic diseases or patients with a medical history of anaphylactic reactions (including patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide (DMSO), mannitol, dextran 40 or bovine proteins)
- Patients who have been treated with injections to the target knee within the past three months or patients with a past history of surgery, including arthroscope, within the past six months
- Patients currently with leukemia or malignant tumors such as osteochondroma, chondroblastoma, cartilaginous mucinous fibrous tumor, chondroma and chondrosarcoma, which may be exacerbated by administration of INVOSSA-K inj. or patients with a history thereof
- Patients with Kellgran \& Lawrence grade 4 osteoarthritis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yeungnam University Hospital
Daegu, Gyeongsangbuk-do, 42415
About this study
Official title: Post Marketing Surveillance on Safety and Effectiveness Evaluation of INVOSSA K Inj.
This study is post-marketing surveillance of Invossa K injection in patients with osteoarthritis.
- Conditions
- Osteoarthritis
- Keywords
- chondrocyte cells, osteoarthritis, gene therapy
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs (Adverse Events)
Changes of incidence rate in AEs
Measured: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Secondary outcomes (5)
100 mm VAS (Visual Analog Scale)
Changes of 100 mm VAS at each visit (Scale : 0~100, 0 : No pain, 100 : Worst imaginable pain)
Measured: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Physical examination (Knee joint swelling)
Changes of Knee joint swelling at each visit
Measured: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Physical examination (Tenderness)
Changes of tenderness at each visit
Measured: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Physical examination (ROM)
Changes of ROM(Range Of Motion) at each visit
Measured: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
General efficacy evaluation
General efficacy evaluation was assessed by following 4 criteria. (Improved, Not changed, Worsened, Unassessable)
Measured: 6 Months(visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start12 Jul 2017
- Primary completion11 Jul 2023 (estimated)
- Study completion11 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolon Life Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oog Jin Shon, MD, PhD., Principal investigator, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412864
- Sponsor's protocol ID
- KS-INVOSSA-PMS
- Status last verified
- May 2019
- First submitted
- 19 Jan 2018
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance on Safety and Effectiveness Evaluation of INVOSSA K Inj.
- ClinicalTrials.gov ID
- NCT03412864
- Acronym / sponsor ID
- KS-INVOSSA-PMS
- Conditions
- Osteoarthritis
- Keywords
- chondrocyte cells, osteoarthritis, gene therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Kolon Life ScienceIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 11 Jul 2023 (estimated)
- Study completion
- 11 Jul 2023 (estimated)
- First posted
- 29 Jan 2018 (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.
This study is post-marketing surveillance of Invossa K injection in patients with osteoarthritis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients over 19 years with osteoarthritis
Key inclusion criteria (4 listed)
- Male or female patients over 19 years
- Patients who diagnosed with osteoarthritis will plan to INVOSSA K Inj. injection and suitable for following criteria :
- Patients (or substitute) who is provided all information regarding participation of this PMS signed the informed consent form
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding female
- Patients who have administered corticosteroid before INVOSSA K Inj. injection within the past 30 days
- Patients who have severe disease such as heart, liver, kidney disease or other severe complications
- Patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis
- Patients with a medical history of allergic diseases or patients with a medical history of anaphylactic reactions (including patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide (DMSO), mannitol, dextran 40 or bovine proteins)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AEs (Adverse Events)
Time frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Changes of incidence rate in AEs
5 secondary outcomes
100 mm VAS (Visual Analog Scale)
Time frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Physical examination (Knee joint swelling)
Time frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Physical examination (Tenderness)
Time frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Physical examination (ROM)
Time frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
General efficacy evaluation
Time frame: 6 Months(visit 3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
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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.
Oog Jin Shon, MD, PhD. principal investigator
Yeungnam University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Kolon Life Science at 1 site in South Korea.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
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?
AEs (Adverse Events) (time frame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)). 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 28 May 2019.