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Methorexate and Knee Osteoarthritis

NCT04326894 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2020-03-30

No results posted yet for this study

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

DRUG

25 mg/week oral methotrexate tablets

DRUG

25mg/week oral placebo tablets

Sponsors & Collaborators

  • University of Alexandria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326894 on ClinicalTrials.gov