Methorexate and Knee Osteoarthritis

Pain Reduction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326894
• Other study ID #: alexmed1391963211966
• Status: Completed
• Phase: Phase 4
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

Inclusion Criteria:

• primary knee osteoarthritis

• synovitis

• pain

Exclusion Criteria:

• other inflammatory conditions

• hepatic insufficiency

• renal insufficiency

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain Reduction
• Physical Function Improvement

Intervention

Drug:
• 25 mg/week oral methotrexate tablets

• 25mg/week oral placebo tablets

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	The primary outcome measure was pain reduction.Pain was assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm).	8 months
Secondary	Physical function improvement	Functional assessment was performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores.	8 months