Methotrexate in Symptomatic Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Methotrexate; Drug: Placebo

• Registration Number: NCT01654575
• Lead Sponsor: University of Alexandria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Status Verified: 2012-07
• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-28
• Last Update Submitted: 2012-07-28
• Study First Posted: 2012-08-01
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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

Exclusion Criteria

• any other inflammatory conditions,
• hepatic and renal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methotrexate	Methotrexate	25mg/week orally
Placebo	Placebo	Placebo-"sugar tablets" identical in colour and shape to methotrexate given once a week for 16 weeks.

Primary Outcome Measures

Name	Time	Method
Pain reduction	16 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in physical function scores	4 months

Trial Locations

Locations (1)

Faculty of Medicine, University of Alexandria; 🇪🇬 Alexandria, Egypt