ArtiAid® Plus for Knee Osteoarthritis: A Post-market Study

Hyaluronic Acid Clinical Trial

Official title:

Intra-Articular Hyaluronic Acid (ArtiAid® Plus) for Knee Osteoarthritis: A Post-market, Open-Label, Long-Term Historical Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881317
• Other study ID #: MCQ-200305
• Status: Completed
• Phase: N/A
• Start date: August 2, 2021
• Est. completion date: November 21, 2022

Study information

• Verified date: May 2023
• Source: Maxigen Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this open-label, post-market clinical follow-up study is to demonstrate the safety and performance of ArtiAid® Plus Intra-articular Injection in patients with knee osteoarthritis(OA). The main questions it aims to answer are:

• the safety profile of ArtiAid® Plus;

• the clinical performance of ArtiAid® Plus, such as pain relief and satisfaction of treatment.

Participants will receive weekly injections of ArtiAid® Plus for 3 weeks and be follow-up for 26 weeks.

Description:

An open-label study will be performed in single center to monitor about 60 patients with knee osteoarthritis(OA), each treated with 3 injections of ArtiAid® Plus 1.5% (MAXIGEN BIOTECH INC., Taiwan). Follow-up visits will be at 4 weeks, 12 weeks(a telephone contact by the investigator) and 26 weeks after the injections. The primary endpoint of this study is to monitor the adverse events after injecting ArtiAid® Plus. The secondary endpoints of this study are demonstrating the clinical performance of ArtiAid® Plus, such as resting knee pain and satisfaction of treatment by using the visual analog scale (VAS). Analysis of variance (ANOVA) will be applied to the clinical data and T-test will be used to test for the differences between baseline and each visit. The paired student t-test was used to analyze variations in each group over a period of time. Statistical significance was established at p < 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 21, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Subjects aged older than 40 years old.

• Able to sign informed consent prior to the study.

• Subjects have Kellgren-Lawrence (KL) grade 2 to 3 knee osteoarthritis.

• Subjects have failed to respond adequately to conservative non-pharmacological therapy.

• Plasma pregnancy test at screening visit must be negative for fertile female subjects.

• Subjects in stable progress of disease as judged by the investigator.

Exclusion Criteria:

• Subjects with known hypersensitivity to hyaluronate preparations.

• Subjects with infections or skin diseases in the area of the injection site.

• Pregnancy or breast-feeding woman.

• Significant drug, alcohol abuse.

• Joining any clinical trial within 3 months prior to dosing.

• Subjects have traveled abroad within 3 months prior to the screening visit.

Related Conditions & MeSH terms

• Hyaluronic Acid
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• ArtiAid® Plus Intra-articular Injection
Inject ArtiAid® Plus in the affected joint at weekly interval for 3 weeks

Locations

Country	Name	City	State
Taiwan	Maxigen Biotech Inc.	Taoyuan City	Taiwan (r.o.c.)

Sponsors (1)

Lead Sponsor	Collaborator
Maxigen Biotech Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-related Adverse Events	The adverse events are defined as any unfavorable sign occurrence in a subject after treatment. The investigator assesses the severity and the relationship of each event to the use of the study device.	0 week to 26 weeks after injections
Secondary	Resting knee pain: VAS (visual analog scale)	Current level of resting knee pain will be assessed by a patient-reported VAS (visual analog scale), subjects mark on a 0-100 mm line, where 0 represent "no pain" and 100 represents "maximum pain". The VAS pain score will be assessed at baseline 4 weeks and 26 weeks after injections.	Baseline, 4 weeks, and 26 weeks after injections
Secondary	Satisfaction of treatment: VAS (visual analog scale)	The satisfaction of treatment will be assessed by a patient-reported VAS (visual analog scale), subjects mark on a 0-100 mm line, where 0 represent "least satisfied" and 100 represents "highest satisfaction". The VAS pain score will be assessed at 4 weeks and 26 weeks after injections.	4 weeks, and 26 weeks after injections