Hyaluronic AcidNCT05881330
ArtiAid® for Knee Osteoarthritis: A Post-market Study
A study testing ArtiAid Intra-articular Injection in people with Hyaluronic Acid, run by Maxigen Biotech Inc. at 1 site in Taiwan.
Trial summary
The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Intra-articular Injection in patients with knee osteoarthritis(OA). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hyaluronic Acid
- What is being tested?
- ArtiAid Intra-articular Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2021to 25 Nov 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged older than 40 years old.
- Able to sign informed consent prior to the study.
- Subjects have Kellgren-Lawrence (KL) grade 2 to 3 knee osteoarthritis.
- Subjects have failed to respond adequately to conservative non-pharmacological therapy.
- Plasma pregnancy test at screening visit must be negative for fertile female subjects.
- Subjects in stable progress of disease as judged by the investigator.
Who cannot join
- Subjects with known hypersensitivity to hyaluronate preparations.
- Subjects with infections or skin diseases in the area of the injection site.
- Pregnancy or breast-feeding woman.
- Significant drug, alcohol abuse.
- Joining any clinical trial within 3 months prior to dosing.
- Subjects have traveled abroad within 3 months prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-Articular Hyaluronic Acid(ArtiAid® ) for Knee Osteoarthritis: A Post-market, Open-Label, Long-Term Historical Control Study
The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:
- the safety profile of ArtiAid®;
- the clinical performance of ArtiAid®, such as pain relief and satisfaction of treatment.
Participants will receive weekly injections of ArtiAid® for 5 weeks and be follow-up for 26 weeks.
Read the detailed description
An open-label study will be performed in single center to monitor about 60 patients with knee osteoarthritis(OA), each treated with 5 injections of ArtiAid® 1.0% (MAXIGEN BIOTECH INC., Taiwan). Follow-up visits will be at 4 weeks, 12 weeks(a telephone contact by the investigator) and 26 weeks after the injections. The primary endpoint of this study is to monitor the adverse events after injecting ArtiAid®. The secondary endpoints of this study are demonstrating the clinical performance of ArtiAid®, such as resting knee pain and satisfaction of treatment by using the visual analog scale (VAS). Analysis of variance (ANOVA) will be applied to the clinical data and t-test will be used to test for the differences between baseline and each visit. The paired student t-test was used to analyze variations in each group over a period of time. Statistical significance was established at p < 0.05.
- Conditions
- Hyaluronic Acid
- Being tested
- ArtiAid Intra-articular Injection
- Keywords
- Viscosupplements, Osteoarthritis, Knee, Injections, Intra-Articular
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtiAid Intra-articular InjectionDevice
Inject ArtiAid® in the affected joint at weekly interval for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ArtiAid® group | Experimental | Each pre-filled syringe contains 10 mg/ml (1.0%) sodium hyaluronate, subjects received one injection per week for five weeks. Receives: Device: ArtiAid Intra-articular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-related Adverse Events
The adverse events are defined as any unfavorable sign occurrence in a subject after treatment. The investigator assesses the severity and the relationship of each event to the use of the study device.
Measured: 0 week to 26 weeks after injections
Secondary outcomes (2)
Resting knee pain: VAS (visual analog scale)
Current level of resting knee pain will be assessed by a patient-reported VAS (visual analog scale), subjects mark on a 0-100 mm line, where 0 represent "no pain" and 100 represents "maximum pain". The VAS pain score will be assessed at baseline 4 weeks and 26 weeks after injections.
Measured: Baseline, 4 weeks, and 26 weeks after injections
Satisfaction of treatment: VAS (visual analog scale)
The satisfaction of treatment will be assessed by a patient-reported VAS (visual analog scale), subjects mark on a 0-100 mm line, where 0 represent "least satisfied" and 100 represents "highest satisfaction". The VAS pain score will be assessed at 4 weeks and 26 weeks after injections.
Measured: 4 weeks, and 26 weeks after injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jul 2021
- Primary completion22 Sep 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaluronic AcidStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxigen Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tsu-Te Yeh, Doctor, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881330
- Sponsor's protocol ID
- MCQ-AA2105
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Articular Hyaluronic Acid(ArtiAid® ) for Knee Osteoarthritis: A Post-market, Open-Label, Long-Term Historical Control Study
- ClinicalTrials.gov ID
- NCT05881330
- Acronym / sponsor ID
- MCQ-AA2105
- Conditions
- Hyaluronic Acid
- Keywords
- Viscosupplements, Osteoarthritis, Knee, Injections, Intra-Articular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Maxigen Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 31 May 2023 (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.
The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:
- the safety profile of ArtiAid®;
- the clinical performance of ArtiAid®, such as pain relief and satisfaction of treatment.
Participants will receive weekly injections of ArtiAid® for 5 weeks and be follow-up for 26 weeks.
Detailed description
An open-label study will be performed in single center to monitor about 60 patients with knee osteoarthritis(OA), each treated with 5 injections of ArtiAid® 1.0% (MAXIGEN BIOTECH INC., Taiwan). Follow-up visits will be at 4 weeks, 12 weeks(a telephone contact by the investigator) and 26 weeks after the injections. The primary endpoint of this study is to monitor the adverse events after injecting ArtiAid®. The secondary endpoints of this study are demonstrating the clinical performance of ArtiAid®, such as resting knee pain and satisfaction of treatment by using the visual analog scale (VAS). Analysis of variance (ANOVA) will be applied to the clinical data and t-test will be used to test for the differences between baseline and each visit. The paired student t-test was used to analyze variations in each group over a period of time. Statistical significance was established at p < 0.05.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ArtiAid® group | Experimental | Device: ArtiAid Intra-articular InjectionEach pre-filled syringe contains 10 mg/ml (1.0%) sodium hyaluronate, subjects received one injection per week for five weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged older than 40 years old.
- Able to sign informed consent prior to the study.
- Subjects have Kellgren-Lawrence (KL) grade 2 to 3 knee osteoarthritis.
- Subjects have failed to respond adequately to conservative non-pharmacological therapy.
- Plasma pregnancy test at screening visit must be negative for fertile female subjects.
Key exclusion criteria (6 listed)
- Subjects with known hypersensitivity to hyaluronate preparations.
- Subjects with infections or skin diseases in the area of the injection site.
- Pregnancy or breast-feeding woman.
- Significant drug, alcohol abuse.
- Joining any clinical trial within 3 months prior to dosing.
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 |
|---|---|---|
| ArtiAid Intra-articular InjectionInject ArtiAid® in the affected joint at weekly interval for 5 weeks. | Device | ArtiAid® group |
Primary outcome
Incidence of Treatment-related Adverse Events
Time frame: 0 week to 26 weeks after injections
The adverse events are defined as any unfavorable sign occurrence in a subject after treatment. The investigator assesses the severity and the relationship of each event to the use of the study device.
2 secondary outcomes
Resting knee pain: VAS (visual analog scale)
Time frame: Baseline, 4 weeks, and 26 weeks after injections
Satisfaction of treatment: VAS (visual analog scale)
Time frame: 4 weeks, and 26 weeks after injections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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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.
Tsu-Te Yeh, Doctor principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArtiAid Intra-articular Injection in people with Hyaluronic Acid, run by Maxigen Biotech Inc. at 1 site in Taiwan.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 31 May 2023. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Treatment-related Adverse Events (time frame: 0 week to 26 weeks after injections). 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 31 May 2023.