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Methotrexate in Symptomatic Knee Osteoarthritis

Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01654575
Enrollment
88
Registered
2012-08-01
Start date
2011-07-31
Completion date
2012-01-31
Last updated
2012-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Methotrexate, Knee Osteoarthritis, Synovitis, Pain reduction, Function scores

Brief 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.

Interventions

DRUGMethotrexate

Methotrexate 25mg/week for 16 weeks

DRUGPlacebo

Placebo tablets once a week for 16 weeks

Sponsors

University of Alexandria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* any other inflammatory conditions, * hepatic and renal insufficiency

Design outcomes

Primary

MeasureTime frame
Pain reduction4 months

Secondary

MeasureTime frame
Improvement in physical function scores4 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026