Status:
RECRUITING
ArtiBest for Knee Osteoarthritis
Lead Sponsor:
Maxigen Biotech Inc.
Conditions:
Knee Osteoarthristis
Eligibility:
All Genders
35-85 years
Phase:
NA
Brief 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 fro...
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 plan...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06994546
Start Date
March 11 2025
End Date
April 30 2026
Last Update
May 29 2025
Active Locations (1)
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1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan