NCT04326894

Methorexate and Knee Osteoarthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: University of Alexandria · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.Synovial inflammation and proliferation has emerged as a key component of OA and as a potential predictor of worsening disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate (MTX) in decreasing pain and inflammation in symptomatic knee OA. 128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited. Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores. Keywords: methotrexate knee osteoarthritis inflammation pain reduction physical funtion

Conditions

• Pain Reduction
• Physical Function Improvement

Interventions

Type	Name	Description
DRUG	25 mg/week oral methotrexate tablets
DRUG	25mg/week oral placebo tablets

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2020-03-30
• Last updated: 2020-03-30

Locations

1 site across 1 country: Egypt