Actively Recruiting
ArtiBest for Knee Osteoarthritis
Led by Maxigen Biotech Inc. · Updated on 2025-05-29
60
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ArtiBest for Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 35 to 85 years
- X-ray evidence of knee osteoarthritis as Kellgren Lawrence grade 2 or 3 within 1 month at screening
- Diagnosis of mild to moderate knee osteoarthritis with inadequate response to conservative nonpharmacologic therapies or analgesics
- Resting pain score of 30 mm or higher on a 100 mm scale at both screening and treatment visits
- Ability and willingness to comply with all study visits and procedures
- Willing and capable of providing written informed consent
You will not qualify if you...
- Known hypersensitivity to hyaluronate
- Infections or skin diseases at the injection site
- Pregnancy or breastfeeding
- Participation in other interventional trials within 3 months prior to injection
- Intra-articular injection of hyaluronic acid or steroids in target knee within 6 months prior to the trial
- Rheumatoid arthritis
- Surgery to the target knee within 12 months prior to the trial or surgery to contralateral knee or weight-bearing joint that may interfere with assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
Research Team
C
Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here