Methotrexate for knee osteoarthritis with ultrasound-proven synovitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, placebo-controlled trial at Bangabandhu Sheikh Mujib Medical University enrolling 70 patients with primary knee osteoarthritis and ultrasound-proven synovitis between July 2025 and June 2026. Eligible participants are 40–70 years old with Kallgren-Lawrence grade 2–3 OA, persistent knee pain (VAS ≥40 mm) for at least six months, and synovitis on musculoskeletal ultrasound. Participants will be randomized to methotrexate or placebo and monitored for changes in synovitis and pain along with routine safety labs. The trial excludes patients with inflammatory arthritis, major organ dysfunction, recent corticosteroid use, extreme obesity (BMI ≥40), prior knee surgery, or severe valgus deformity.

Why it matters

Who can join: the full rules

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), 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

Where it's running

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  Dhaka, Dhaka Division, Bangladesh Recruiting

Study contacts

• Study coordinator: Akash Ahmed Alif, MBBS
• Email: akash.alif@gmail.com
• Phone: +8801726459070

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.