Role of Methotrexate in Ultrasound Proven Synovitis in Primary Knee OA
Background: Osteoarthritis (OA) is a leading cause of disability worldwide, with limited treatment options and many patients suffering from chronic pain. Modern imaging has revealed that OA involves complex changes in cartilage, subchondral bone, and synovium. Pain in OA is often linked to synovitis, which is common in
| Condition(s) | Osteo Arthritis of the Knee, Synovitis of Knee, Methotrexate |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Background: Osteoarthritis (OA) is a leading cause of disability worldwide, with limited treatment options and many patients suffering from chronic pain. Modern imaging has revealed that OA involves complex changes in cartilage, subchondral bone, and synovium. Pain in OA is often linked to synovitis, which is common in the condition. Methotrexate (MTX), a proven treatment for synovitis in inflammatory arthritis like rheumatoid arthritis and has a well-known safety profile. The proposal suggests that using MTX may have potential to treat symptomatic knee OA with USG (musculoskeletal ultrasound) proven synovitis by reducing synovitis and as a result, alleviate pain. Objectives: To assess the role of methotrexate in primary knee osteoarthritis associated with ultrasound proven synovitis. Meth |
| Who can participate | Inclusion Criteria: * Men and women aged between 40 to 70 years * Patients fulfilling American College of Rheumatology (ACR) clinical and radiological criteria for knee OA. (knee pain + at least 3 of 5 that not including "no palpable warmth") * Knee pain on most days for at least 6 months, with a pain VAS of at least 40mm * Radiological grading of OA with Kallgren-Lawrence grade of 2 to 3 * Patients with the presence of knee synovitis in Musculoskeletal ultrasound Exclusion Criteria: * Any known inflammatory arthritis * BMI \>= 40 kg/m2 * Abnormal renal (e.g. abnormal renal function Creatinine clearance \<35 ml) hepatic (including active hepatitis B, hepatitis C, abnormal liver function), hematological (e.g. white cell count \< 4 × 109/L, platelets \<100 ×109/L, or hemoglobin \< 9 g/dL), f |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Lead sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
| Locations | Dhaka, Dhaka Division, Bangladesh |
| Start date | 2025-07-30 |
| NCT ID | NCT07161336 |
| Official listing | https://clinicaltrials.gov/study/NCT07161336 |