Methotrexate in Symptomatic Knee Osteoarthritis

July 28, 2012 updated by: Anna Abou-Raya, University of Alexandria

Randomized Controlled Trial Using Methotrexate for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Medicine, University of Alexandria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • any other inflammatory conditions,
  • hepatic and renal insufficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Methotrexate
25mg/week orally
Drug: Methotrexate
Methotrexate 25mg/week for 16 weeks
ACTIVE_COMPARATOR: Placebo
Placebo-"sugar tablets" identical in colour and shape to methotrexate given once a week for 16 weeks.
Drug: Placebo
Placebo tablets once a week for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain reduction
Time Frame: 16 weeks
16 weeks
Pain reduction
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in physical function scores
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Investigators

  • Study Director: Anna Abou-Raya, MD, University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

July 26, 2012

First Submitted That Met QC Criteria

July 28, 2012

First Posted (ESTIMATE)

August 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 28, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • alexmed116662981

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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