Methotrexate for knee osteoarthritis with ultrasound-proven synovitis
Role of Methotrexate in Ultrasound Proven Synovitis in Patients With Knee Osteoarthritis : A Randomized Controlled Trial
This randomized trial will try methotrexate versus placebo to see if it reduces pain and inflamed lining (synovitis) in people aged 40–70 with knee osteoarthritis confirmed by ultrasound.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 1 site (Dhaka, Dhaka Division) |
| Trial ID | NCT07161336 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 40–70 with chronic knee pain (≥6 months), K-L grade 2–3 knee OA, pain VAS ≥40 mm, and ultrasound-confirmed knee synovitis who meet the study's lab and health criteria.
Not a fit: Those with known inflammatory arthritis, BMI ≥40 kg/m2, abnormal renal/hepatic/hematologic tests, recent steroid injections, prior knee surgery, or severe valgus deformity are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, methotrexate could reduce knee pain and synovial inflammation and provide a relatively low-cost treatment option for OA patients with synovitis.
How similar studies have performed: Some small prior trials and case reports have suggested methotrexate may help pain in OA with synovitis, but overall evidence is limited and mixed, so benefit is not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dhaka, Dhaka Division
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.