Status:
RECRUITING
Role of Methotrexate in Ultrasound Proven Synovitis in Primary Knee OA
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions:
Osteo Arthritis of the Knee
Synovitis of Knee
Eligibility:
All Genders
40-70 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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), function
- Use of intra-articular, intramuscular or oral corticosteroids in previous 4 weeks
- History knee joint surgery, Charcot joint
- Severe valgus knee deformity (angle of genu valgum \> 30°)
- Use of any disease modifying agents (e.g. hydroxychloroquine or sulfasalazine) in previous 3 months
- Allergic to MTX
- Pregnant or lactating women
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07161336
Start Date
July 30 2025
End Date
August 30 2026
Last Update
September 12 2025
Active Locations (1)
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1
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Dhaka, Dhaka Division, Bangladesh