ArtiBest for Knee Osteoarthritis
ConditionKnee Osteoarthristis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-85
SponsorMaxigen Biotech Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ArtiBest ® Intra articular Injection
Devicesingle intra articular injection of 3 ml (one syringe) per knee joint. Each syringe contains 20 mg/mL sodium hyaluronate.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: ABExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Week 0 and 26 weeks post injectionSecondary outcomes
1
The change of VAS resting pain score
The change from baseline VAS resting pain score at 12 and 26 weeks post injection.
Time frame
Week 0, 12 and 26 weeks post injection2
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 12 weeks post injection.
Time frame
Week 0, 12 weeks post injection3
The change of Patient's Global Assessment (PGA)
The change from baseline Patient's Global Assessment (PGA) using VAS scoring at 12 and 26 weeks post injection.
Time frame
Week 0, 12 and 26 weeks post injection4
The OMERACT OARSI responder rate
The OMERACT OARSI responder rate at 12 and 26 weeks post injection.
Time frame
12 and 26 weeks post injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov