CompletedNot Applicable

Methotrexate in the Treatment of Advanced Knee Osteoarthritis With Effusion-synovitis

China215 participantsStarted 2019-07-18

Plain-language summary

This multicentre randomized placebo-controlled clinical trial aims to evaluate whether methotrexate (MTX) has effects of relieving symptoms and reducing inflammation on advanced knee osteoarthritis (OA) with inflammatory phenotype. Participants will be randomly allocated to either MTX group or placebo group receiving MTX or placebo once a week. The primary outcomes are effusion-synovitis volume measured by magnetic resonance imaging (MRI) and knee pain assessed by visual analogue scale (VAS).

Who can participate

Age range

45 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meet the America College of Rheumatology (ACR) criteria for clinical knee OA assessed by a rheumatologist * Knee pain, visual analogue scale (VAS) pain at least 40mm * Kellgren-Lawrence(K-L) grade of 2-4 * Physical examination showed signs of inflammation (at least 2 of the following 4 clinical signs of inflammation: warmth around the joint; tenderness around joint margin; articular cavity effusion; swelling of soft tissue around the knee joint) * MRI evaluated effusion synovitis grade of ≥ 2 * Capable of understanding the study requirements and willing to cooperate with study instructions, and voluntarily sign informed consent Exclusion Criteria: * Inflammatory arthritis (such as gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondyloarthropathy), systemic lupus erythematosus * Knee surgery or arthroscopic examinations were performed or planned within one year, Severe valgus knee deformity (angle of genu valgum \> 30°) or previous traumatic history * MRI contraindications * Intra-articular injection, intramuscular injection or oral glucocorticoid were used within the last 4 weeks * Other anti-synovitis agents (such as hydroxychloroquine and sulfasalazine) were applied in the past 3 months * Clinical significant conditions, such as (but not limited to) active malignant tumor, abnormal renal function (assessed by GFR), hepatic abnormalities \[active hepatitis B, hepatitis C, abnormal liver function (ALT is more than t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effusion-synovitis

Timeframe: 12 months

VAS knee pain

Timeframe: 12 months

Trial details

NCT IDNCT03815448

SponsorZhujiang Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

View on ClinicalTrials.gov More Knee Osteoarthritis trials