Methotrexate in Symptomatic Knee Osteoarthritis

University of Alexandria

Status: Completed

Conditions: Osteoarthritis

Treatments: Drug: Methotrexate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01654575

alexmed116662981

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• any other inflammatory conditions,
• hepatic and renal insufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups

Methotrexate

Experimental group

Description:

25mg/week orally

Treatment:

Drug: Methotrexate

Placebo

Active Comparator group

Description:

Placebo-"sugar tablets" identical in colour and shape to methotrexate given once a week for 16 weeks.

Treatment:

Drug: Placebo