ArtiBest for Knee Osteoarthritis

NCT06994546 | Recruiting

• 1 other identifier: MBI-AB-202408
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 26 weeks post injection.
2. 2.The change from baseline VAS resting pain score at 12 and 26 weeks post injection.
3. 3.The change from baseline The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 12 weeks post injection.
4. 4.The change from baseline Patient's Global Assessment PGA) using VAS scoring at 12 and 26 weeks post injection.
5. 5.The OMERACT OARSI responder rate at 12 and 26 weeks post injection.
6. 6.The VAS satisfaction score at 12 and 26 weeks post injection
7. 7.The incidence of Adverse events reported during the study period.

Conditions

Knee Osteoarthristis

Keywords

hyaluronic acid; intra articular injection

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 0 and 26 weeks post injection

Secondary Outcomes (5)

• The change of VAS resting pain score

  Week 0, 12 and 26 weeks post injection

• The change of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score

  Week 0, 12 weeks post injection

• The change of Patient's Global Assessment (PGA)

  Week 0, 12 and 26 weeks post injection

• The OMERACT OARSI responder rate

  12 and 26 weeks post injection

• The VAS satisfaction score

  12 and 26 weeks post injection

Study Arms (1)

AB

EXPERIMENTAL

Device: ArtiBest ® Intra articular Injection

Interventions

ArtiBest ® Intra articular Injection DEVICE

single intra articular injection of 3 ml (one syringe) per knee joint. Each syringe contains 20 mg/mL sodium hyaluronate.

AB

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maxigen Biotech Inc.: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Central Study Contacts

Chen

CONTACT

+88633287222; lirong.chen@mbi.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: March 11, 2025
• Primary Completion: November 30, 2025
• Study Completion: April 30, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

TW (1)