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Methotrexate in Symptomatic Knee Osteoarthritis

Information source: Faculty of Medicine, University of Alexandria
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis

Intervention: Methotrexate (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Faculty of Medicine, University of Alexandria

Official(s) and/or principal investigator(s):
Anna Abou-Raya, MD, Study Director, Affiliation: Faculty of Medicine, University of Alexandria

Summary

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.

Clinical Details

Official title: Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Pain reduction

Pain reduction

Secondary outcome: Improvement in physical function scores

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- primary knee osteoarthritis

- pain not responding to the usual therapy

- synovitis

Exclusion Criteria:

- any other inflammatory conditions,

- hepatic and renal insufficiency

Locations and Contacts

Faculty of Medicine, University of Alexandria, Alexandria, Egypt
Additional Information

Starting date: July 2011
Last updated: July 28, 2012

Page last updated: August 23, 2015

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