Methotrexate in Symptomatic Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654575
• Other study ID #: alexmed116662981
• Status: Completed
• Phase: N/A
• First received: July 26, 2012
• Last updated: July 28, 2012
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: Faculty of Medicine, University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Methotrexate
Methotrexate 25mg/week for 16 weeks
• Placebo
Placebo tablets once a week for 16 weeks

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, University of Alexandria	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction		4 months	Yes
Primary	Pain reduction		16 weeks	Yes
Secondary	Improvement in physical function scores		4 months	Yes