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

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).

Conditions

• Knee Osteoarthritis
• Effusion Synovial
• Knee Pain

Interventions

DRUG

Methotrexate

Participants randomized to methotrexate group will receive active drug, methotrexate. Starting from 5 mg/week, the dosage will be adjusted to 10 mg/week if the participants can tolerate for 2 weeks. After 2 weeks, the dosage will be adjusted to 15 mg/week until the end of the study if the participants can tolerate.

OTHER

Placebo

Participants randomized to placebo group will receive placebo tablets. Starting from 5 mg/week for 2 weeks, the dosage will be adjusted to 10 mg/week; after 2 weeks, the dosage will be adjusted to 15 mg/week until the end of the study.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Xuanwu Hospital, Beijing

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• The Second People's Hospital of GuangDong Province

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Shenzhen Third People's Hospital

  collaborator OTHER

• Central People's Hospital of Zhanjiang

  collaborator OTHER

• Qingyuan People's Hospital

  collaborator OTHER

• Zhujiang Hospital

  lead OTHER

Principal Investigators

• Changhai Ding, MD · Clinical Research Center of Zhujiang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-18

Primary Completion

2023-11-01

Completion

2023-12-01

Countries

• China

Study Locations