Methorexate and Knee Osteoarthritis

NCT ID: NCT04326894

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-12-31

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

Conditions

Pain Reduction; Physical Function Improvement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methotrexate

25mg oral MTX tablets

Group Type: EXPERIMENTAL

25 mg/week oral methotrexate tablets

Intervention Type: DRUG

Placebo

25 mg/week placebo tablets

Group Type: PLACEBO_COMPARATOR

25mg/week oral placebo tablets

Intervention Type: DRUG

Interventions

25 mg/week oral methotrexate tablets

Intervention Type: DRUG

25mg/week oral placebo tablets

Intervention Type: DRUG

Other Intervention Names

interventional drug

Eligibility Criteria

Inclusion Criteria

• primary knee osteoarthritis
• synovitis
• pain

Exclusion Criteria

• other inflammatory conditions
• hepatic insufficiency
• renal insufficiency

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alexandria

OTHER

Sponsor Role: lead

Responsible Party

Anna Abou-Raya

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

alexmed1391963211966

Identifier Type: -

Identifier Source: org_study_id