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Could a common arthritis drug ease knee osteoarthritis pain?

NCT ID NCT07161336

Symptom relief Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether methotrexate, a drug used for rheumatoid arthritis, can reduce pain and swelling in people with knee osteoarthritis who also have joint inflammation (synovitis). Seventy adults aged 40–70 will receive either methotrexate or a placebo for 6 months. Researchers will measure pain, function, and ultrasound signs of inflammation to see if the drug helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methotrexate
What this could lead to
If it works, this could point toward a new way to ease pain and improve function in people with knee osteoarthritis who have joint inflammation.
What could go wrong
This is a small, early-phase trial with only 70 participants. Methotrexate may not reduce pain better than placebo, and it can cause side effects like nausea or liver issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee synovitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Methotrexate Osteo arthritis of the knee Synovitis of knee

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    RECRUITING

    Dhaka, Dhaka Division, Bangladesh

More trials for these conditions

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