Osteoarthritis (OA) of the Knee
Conditions
Keywords
Mobithron Advance
Brief summary
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
Detailed 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.
Interventions
DRUGType 2 collagen
This study's intervention is undenatured type II collagen (UC-II) oral tablets, one daily for 12 months, targeting knee osteoarthritis (KL grade 1-3). It differs from other interventions such as glucosamine, chondroitin, hyaluronic acid, or NSAIDs by working through an oral tolerance mechanism with the potential to preserve cartilage and modify disease progression, rather than providing only short-term symptom relief.
Sponsors
Universiti Sains Malaysia
BREGO Life Sciences Sdn Bhd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This Mobithron study uses a prospective, single-arm interventional clinical trial model, where all patients will receive Mobithron Advance daily for 12 months. This design allows you to follow participants forward in time and directly assess the effects of the intervention on knee osteoarthritis outcomes, including cartilage preservation, pain reduction, functional improvement, and safety. The single-arm approach is suitable for an early-stage study of a novel therapeutic, focusing on generating essential safety and efficacy data before progressing to randomised controlled trials. By including patients across Kellgren-Lawrence grades 1-3, the study also explores how disease severity influences treatment response.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to assess the thickness of cartilage in osteoarthritic knee included in the study at 3 stages. pre treatment, mid treatment and post treatment. | 1 year | in term of cartilage assessment, MAGNETIC RESONANCE IMAGING (MRI) PROTOCOL is going to be used; in which, Multiplanar reconstruction (MPR) of the 3D WATSc image will be done to determine the location of central medial femoral condyle cartilage, where thickness of the central medial femoral condyle (cMF) cartilage will be measured on sagittal plane at the most central weight bearing surface. with the above outcome measure, the study can look into Mobithron able to preserve and regenerate cartilages in patients, slowing and reversing cartilage losses as well as disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assessment of pain score in knee osteoarthritic patient | 1 year | The outcomes is measured using visual analogue score (VAS) for pain intensity assessment at 3 months interval |
Countries
Malaysia
Contacts
CONTACTMohamad Anas Alfian Bin Sufri Dr., Medicine and Surgery
Outcome results
None listed