Overview
The goal of this clinical trial is to learn if the Mobithron Advance drug works to treat and slow the progression of osteoarthritis (OA) in patients. It will also learn about the safety and long-term effects of this drug. The main questions it aims to answer are:
- Does long-term administration of Mobithron Advance can modify the progression of knee osteoarthritis with Kellgren-Lawrence grade 1 to 3 in HUSM patients?
- Does long term usage of Mobithron Advance has safety profile? Researchers will compare the Mobithron Advance drug to a placebo (a look-alike substance that contains no drug) to see if said drug works to treat OA.
Participants will:
- Undergo pre-study assessment (baseline assessments) during first visit
- Take oral Mobithron Advance daily for 1 year
- Visit the clinic once at 3 months, 6 months and 12 months intervals from the initial visit for follow up assessments
Description
The study will be conducted as a prospective single-arm trial with a one-year follow-up at the Orthopaedic Clinic, Hospital Universiti Sains Malaysia (HUSM), Malaysia. Participants will include adults over 50 years old diagnosed with primary knee osteoarthritis (OA) of Kellgren-Lawrence grade 1 to 3, based on clinical and radiological criteria. A total of 84 patients will be recruited, accounting for a 10% dropout rate, and will receive daily oral Mobithron Advance for 12 months. Pain will be assessed monthly using the Visual Analogue Scale (VAS) and physical function will be evaluated with the WOMAC index at follow-up visits. Cartilage preservation will be measured through MRI scans at baseline, six months, and twelve months, using a cartilage-specific 3D WATSc sequence to monitor central femoral condyle thickness. Safety and tolerability will be assessed by monitoring renal function, including creatinine and eGFR, alongside recording any adverse events. Data will include demographics, clinical outcomes, and radiological findings, and will be analysed using descriptive statistics, paired t-tests or Wilcoxon signed-rank tests, and linear mixed-effects models to evaluate changes over time.
Eligibility
Inclusion Criteria:
- Males and female patients above 50 years old at the time of recruitment.
- OA Diagnosis: Patients with one or both knee osteoarthritis according to clinical and radiological criteria of the American College of Rheumatology (ACR).
- OA Grade: Kellgren Lawrence grade 1-3
Exclusion Criteria:
- Secondary arthritis (e.g., rheumatoid arthritis, psoriatic arthritis).
- History of joint surgery.
- Patients who received steroid injection treatment within the last 3 months or hyaluronic acid injection treatment within the last 6 months.
- Contraindications to Mobithron Advance (e.g., known allergies, severe liver or kidney disease).
- Patients planning for knee surgery within the research period.
- Patients on pharmacological treatment for osteoarthritis, other than rescue analgesic agent, e.g: glucosamine, chondroitin, oral steroid
