Knee OsteoarthristisNCT06994546
ArtiBest for Knee Osteoarthritis
A study testing ArtiBest ® Intra articular Injection in people with Knee Osteoarthristis, run by Maxigen Biotech Inc. at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate the real-world effectiveness and safety of ArtiBest in the treatment of knee osteoarthritis. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- ArtiBest ® 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
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Mar 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 35 to 85 years.
- Subject with x ray imaging evidence of knee OA as Kellgren Lawrence grade = 2 or 3 within 1 month at screening.
- Subject diagnosed with mild to moderate knee OA, particularly in patients who failed to respond adequately to conservative nonpharmacologic therapies or analgesics.
- Subject with a 100 mm VAS resting pain score ≥ 30 mm in the studied knee at both the screening and treatment visit (screening visit and treatment visit can be on the same day)
- Able and willing to comply with all study visits and procedures.
- Willin g and capable of providing written informed consent.
Who cannot join
- Subjects with known hypersensitivity to hyaluronate.
- Subjects with infections or skin diseases in the area of the injection site.
- Pregnancy or breast feeding woman.
- Joining other interventional trial s within 3 months prior to injecting this study product
- Subject receive an intra articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in target knee within 6 months prior to the trial
- Subjects with rheumatoid arthritis
- Any surgery to the target knee within the 12 months prior to the trial, or surgery to the contralateral knee or other weight bearing joint if it will interfere with knee assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Doctor Wu, +886-7-7317-123 ext. 8003, ray4595@gmail.com
About this study
Official title: Intra Articular Hyaluronic Acid (ArtiBest ® ) for Knee Osteoarthritis: A Post-market, Open Label, Long Term Study
The goal of this clinical trial is to evaluate the real-world effectiveness and safety of ArtiBest in the treatment of knee osteoarthritis. The main questions it aims to answer are:
- The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 26 weeks post injection.
- The change from baseline VAS resting pain score at 12 and 26 weeks post injection.
- The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 12 weeks post injection.
- The change from baseline Patient's Global Assessment PGA) using VAS scoring at 12 and 26 weeks post injection.
- The OMERACT OARSI responder rate at 12 and 26 weeks post injection.
- The VAS satisfaction score at 12 and 26 weeks post injection
- The incidence of Adverse events reported during the study period.
Participants will undergo a single injection of ArtiBest at treatment visit, and three follow up visits at week 4 , 12 , and 26.
Read the detailed description
This single center, single arm, open label, interventional study aims to assess the effectiveness and the safety profiles of ArtiBest ® Intra articular Injection(MAXIGEN BIOTECH INC., Taiwan). It plans to enroll approximately 60 eligible patients to receive a 3 ml single pre-filled syringe per knee joint at the treatment visit. Each syringe contains 20 mg/mL sodium hyaluronate. Follow-up visits will be at 4 weeks(a telephone contact by the investigator), 12 weeks and 26 weeks after the injections. All endpoints are planning to evaluate the change between baseline(pre-treatment) and 12 and 26 weeks post-injection. The OMERACT-OARSI responder rate will also be calculated. And the exploratory endpoints will evaluate the change in the range of motion (ROM) at 12 and 26 weeks post-injection. Additionally, the Kellgren-Lawrence grade (KL grade) at baseline and 26 weeks, as well as the target joint space at baseline and 26weeks, will also be analyzed. In general, the change from the baseline of continuous data will be performed by paired t-test or Wilcoxon signed-rank test. The statistical analysis for primary endpoint will be one-sided under a significance level of 0.025. Unless otherwise specified, other statistical analysis will be two-sided under a significance level of 0.05.
- Conditions
- Knee Osteoarthristis
- Being tested
- ArtiBest ® Intra articular Injection
- Keywords
- hyaluronic acid, intra articular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtiBest ® Intra articular InjectionDevice
single intra articular injection of 3 ml (one syringe) per knee joint. Each syringe contains 20 mg/mL sodium hyaluronate.
| Study group | Role | What they receive |
|---|---|---|
| AB | Experimental | Not described Receives: Device: ArtiBest ® Intra articular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score
The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 26 weeks post injection.
Measured: Week 0 and 26 weeks post injection
Secondary outcomes (5)
The change of VAS resting pain score
The change from baseline VAS resting pain score at 12 and 26 weeks post injection.
Measured: Week 0, 12 and 26 weeks post injection
The change of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score
The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 12 weeks post injection.
Measured: Week 0, 12 weeks post injection
The change of Patient's Global Assessment (PGA)
The change from baseline Patient's Global Assessment (PGA) using VAS scoring at 12 and 26 weeks post injection.
Measured: Week 0, 12 and 26 weeks post injection
The OMERACT OARSI responder rate
The OMERACT OARSI responder rate at 12 and 26 weeks post injection.
Measured: 12 and 26 weeks post injection
The VAS satisfaction score
The VAS satisfaction score at 12 and 26 week s post injection.
Measured: 12 and 26 weeks post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start11 Mar 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxigen Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994546
- Sponsor's protocol ID
- MBI-AB-202408
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Articular Hyaluronic Acid (ArtiBest ® ) for Knee Osteoarthritis: A Post-market, Open Label, Long Term Study
- ClinicalTrials.gov ID
- NCT06994546
- Acronym / sponsor ID
- MBI-AB-202408
- Conditions
- Knee Osteoarthristis
- Keywords
- hyaluronic acid, intra articular injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maxigen Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 29 May 2025 (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 clinical trial is to evaluate the real-world effectiveness and safety of ArtiBest in the treatment of knee osteoarthritis. The main questions it aims to answer are:
- The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 26 weeks post injection.
- The change from baseline VAS resting pain score at 12 and 26 weeks post injection.
- The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 12 weeks post injection.
- The change from baseline Patient's Global Assessment PGA) using VAS scoring at 12 and 26 weeks post injection.
- The OMERACT OARSI responder rate at 12 and 26 weeks post injection.
- The VAS satisfaction score at 12 and 26 weeks post injection
- The incidence of Adverse events reported during the study period.
Participants will undergo a single injection of ArtiBest at treatment visit, and three follow up visits at week 4 , 12 , and 26.
Detailed description
This single center, single arm, open label, interventional study aims to assess the effectiveness and the safety profiles of ArtiBest ® Intra articular Injection(MAXIGEN BIOTECH INC., Taiwan). It plans to enroll approximately 60 eligible patients to receive a 3 ml single pre-filled syringe per knee joint at the treatment visit. Each syringe contains 20 mg/mL sodium hyaluronate. Follow-up visits will be at 4 weeks(a telephone contact by the investigator), 12 weeks and 26 weeks after the injections. All endpoints are planning to evaluate the change between baseline(pre-treatment) and 12 and 26 weeks post-injection. The OMERACT-OARSI responder rate will also be calculated. And the exploratory endpoints will evaluate the change in the range of motion (ROM) at 12 and 26 weeks post-injection. Additionally, the Kellgren-Lawrence grade (KL grade) at baseline and 26 weeks, as well as the target joint space at baseline and 26weeks, will also be analyzed. In general, the change from the baseline of continuous data will be performed by paired t-test or Wilcoxon signed-rank test. The statistical analysis for primary endpoint will be one-sided under a significance level of 0.025. Unless otherwise specified, other statistical analysis will be two-sided under a significance level of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AB | Experimental | Device: ArtiBest ® Intra articular Injection |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 35 to 85 years.
- Subject with x ray imaging evidence of knee OA as Kellgren Lawrence grade = 2 or 3 within 1 month at screening.
- Subject diagnosed with mild to moderate knee OA, particularly in patients who failed to respond adequately to conservative nonpharmacologic therapies or analgesics.
- Subject with a 100 mm VAS resting pain score ≥ 30 mm in the studied knee at both the screening and treatment visit (screening visit and treatment visit can be on the same day)
- Able and willing to comply with all study visits and procedures.
Key exclusion criteria (7 listed)
- Subjects with known hypersensitivity to hyaluronate.
- Subjects with infections or skin diseases in the area of the injection site.
- Pregnancy or breast feeding woman.
- Joining other interventional trial s within 3 months prior to injecting this study product
- Subject receive an intra articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in target knee within 6 months prior to the trial
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 |
|---|---|---|
| ArtiBest ® Intra articular Injectionsingle intra articular injection of 3 ml (one syringe) per knee joint. Each syringe contains 20 mg/mL sodium hyaluronate. | Device | AB |
Primary outcome
The change of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score
Time frame: Week 0 and 26 weeks post injection
The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 26 weeks post injection.
5 secondary outcomes
The change of VAS resting pain score
Time frame: Week 0, 12 and 26 weeks post injection
The change of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score
Time frame: Week 0, 12 weeks post injection
The change of Patient's Global Assessment (PGA)
Time frame: Week 0, 12 and 26 weeks post injection
The OMERACT OARSI responder rate
Time frame: 12 and 26 weeks post injection
The VAS satisfaction score
Time frame: 12 and 26 weeks post injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArtiBest ® Intra articular Injection in people with Knee Osteoarthristis, 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 7 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: looking for participants now, as of the sponsor's last update on 29 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen (+88633287222 ext. 1250, lirong.chen@mbi.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score (time frame: Week 0 and 26 weeks post injection). 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 29 May 2025.