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 reductionPain 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
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