Methorexate and Knee Osteoarthritis

Phase 4

Completed

• Conditions: Pain Reduction; Physical Function Improvement
• Interventions: Drug: 25 mg/week oral methotrexate tablets; Drug: 25mg/week oral placebo tablets

• Registration Number: NCT04326894
• Lead Sponsor: University of Alexandria

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-08-08
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• primary knee osteoarthritis
• synovitis
• pain

Exclusion Criteria

• other inflammatory conditions
• hepatic insufficiency
• renal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate	25 mg/week oral methotrexate tablets	25mg oral MTX tablets
Placebo	25mg/week oral placebo tablets	25 mg/week placebo tablets

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt