drugset / Trial / NCT03815448
Methotrexate in the Treatment of Advanced Knee Osteoarthritis With Effusion-synovitis
Completed
215 enrolled
Zhujiang Hospital
Beijing Hospital · collabCentral People's Hospital of Zhanjiang · collabPeking Union Medical College Hospital · collabPeking University People's Hospital · collabQingyuan People's Hospital · collabShenzhen Third People's Hospital · collabThe First Affiliated Hospital of Anhui Medical University · collabThe Second People's Hospital of GuangDong Province · collabThird Affiliated Hospital, Sun Yat-Sen University · collabXuanwu Hospital, Beijing · collab
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2019-07-18
- Primary completion
- 2023-11-01
- Completion
- 2023-12-01
Publications
- Zhu Z, Yu Q, Leng X, Xu J, Ren L, Wang K, Huang C, Pan Y, Zhao Y, Li T, Mei Y, Guan M, Li X, Zhang Z, Wu J, Chen Y, Qu Y, Zhu X, Liao Q, Wang Z, Liao Z, Xi Y, Deng W, Wang K, Zhu T, Zhang Y, Gao L, Zhou X, Han W, Ruan G, Zhang Y, Cao P, Gao P, Chen H, Dang Q, Cicuttini FM, Hunter DJ, Li Z, Zeng X, Ding C. Low-Dose Methotrexate for the Treatment of Inflammatory Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Intern Med. 2025 Jul 1;185(7):808-816. doi: 10.1001/jamainternmed.2025.1359.
- Liu Q, Ren J, Zhang W, Liang T, Wang Z, Xie S, Li Y, Hou J, Wang K, He R. Measured Resection as Gap Balance Method in Mobile-Bearing Medial Unicompartmental Knee Arthroplasty: A Randomized Controlled Trial. Orthop Surg. 2025 Feb;17(2):603-613. doi: 10.1111/os.14346. Epub 2025 Jan 5.
- Zhu Z, Yu Q, Leng X, Han W, Li Z, Huang C, Gu J, Zhao Y, Wang K, Li T, Mei Y, Xu J, Zhang Z, Hunter D, Cicuttini F, Zeng X, Ding C. Can low-dose methotrexate reduce effusion-synovitis and symptoms in patients with mid- to late-stage knee osteoarthritis? Study protocol for a randomised, double-blind, and placebo-controlled trial. Trials. 2020 Sep 16;21(1):795. doi: 10.1186/s13063-020-04687-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 15 mg | Oral |