Methorexate and Knee Osteoarthritis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04326894

Enrollment

128

Registered

2020-03-30

Start date

2011-12-31

Completion date

2012-12-31

Last updated

2020-03-30

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

Conditions

Pain Reduction, Physical Function Improvement

Keywords

methotrxate, knee osteoarthritis, inflammation, pain, function

Brief summary

Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.Synovial inflammation and proliferation has emerged as a key component of OA and as a potential predictor of worsening disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate (MTX) in decreasing pain and inflammation in symptomatic knee OA. 128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited. Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores. Keywords: methotrexate knee osteoarthritis inflammation pain reduction physical funtion

Interventions

DRUG25 mg/week oral methotrexate tablets

DRUG25mg/week oral placebo tablets

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 100 Years

Healthy volunteers

Inclusion criteria

* primary knee osteoarthritis * synovitis * pain

Exclusion criteria

* other inflammatory conditions * hepatic insufficiency * renal insufficiency

Design outcomes

Primary

Measure	Time frame	Description
Pain reduction	8 months	The primary outcome measure was pain reduction.Pain was assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm).

Secondary

Measure	Time frame	Description
Physical function improvement	8 months	Functional assessment was performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores.

Countries

Egypt

Outcome results

None listed

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