Clinical Trial

ArtiBest for Knee Osteoarthritis

Recruiting
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Record status
This record was last updated May 29, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.
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. The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 26 weeks post injection. 2. The change from baseline VAS resting pain score at 12 and 26 weeks post injection. 3. The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 12 weeks post injection. 4. The change from baseline Patient's Global Assessment PGA) using VAS scoring at 12 and 26 weeks post injection. 5. The OMERACT OARSI responder rate at 12 and 26 weeks post injection. 6. The VAS satisfaction score at 12 and 26 weeks post injection 7. 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.
Trial Details
NCT Number NCT06994546
Lead Sponsor Maxigen Biotech Inc.
Conditions Knee Osteoarthristis
Enrollment 60 participants
Start Date 2025-03-11
Primary Completion 2025-11-30 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-29