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OpenTrials
Completed

NCT Number: NCT01654575

Methotrexate in Symptomatic Knee Osteoarthritis

Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic criteria of primary knee OA with knee pain, were included in this study.Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.There was a statistically significant reduction in pain and improvement in function in the MTX group compared to the placebo group at 16 weeks.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis, Knee Rheumatic Diseases Synovitis

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, University of Alexandria

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary knee osteoarthritis
  • pain not responding to the usual therapy
  • synovitis

Exclusion criteria

  • any other inflammatory conditions,
  • hepatic and renal insufficiency

Treatment and study plan

methotrexate

Drug

Methotrexate 25mg/week for 16 weeks

Placebo

Drug

Placebo tablets once a week for 16 weeks

Primary outcomes

  1. Pain reduction

    Time frame: 4 months

  2. Pain reduction

    Time frame: 16 weeks

Secondary outcomes

  1. Improvement in physical function scores

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 1, 2012
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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