An interventional study of ArtiBest ® Intra articular Injection in Knee Osteoarthristis, sponsored by Maxigen Biotech Inc.. Recruiting at 1 site in Taiwan. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Maxigen Biotech Inc. · Not applicable, Interventional, and Treatment
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:
Participants will undergo a single injection of ArtiBest at treatment visit, and three follow up visits at week 4 , 12 , and 26.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Maxigen Biotech Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: ArtiBest ® Intra articular Injection
single intra articular injection of 3 ml (one syringe) per knee joint. Each syringe contains 20 mg/mL sodium hyaluronate.
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.
Time frame: Week 0 and 26 weeks post injection
The change of VAS resting pain score
The change from baseline VAS resting pain score at 12 and 26 weeks post injection.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 and 26 weeks post injection
The VAS satisfaction score
The VAS satisfaction score at 12 and 26 week s post injection.
Time frame: 12 and 26 weeks post injection
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Maxigen Biotech Inc.