This trial is active, not recruiting.

Conditions reduction in pain, reduction of inflammation, improvement in function
Treatments 25 mg/week oral methotrexate tablets, 25mg/week oral placebo tablets
Phase phase 2
Sponsor Faculty of Medicine, University of Alexandria
Start date January 2013
End date August 2013
Trial size 144 participants
Trial identifier NCT01927484, alexmed1391963211975


Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists. Synovitis is commonly demonstrated in knee OA imaging. Synovial inflammation due to the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.

The aim of the present study is to assess the efficacy of MTX in decreasing pain and inflammation in symptomatic knee OA.

Methods: One hundred and forty-four patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with knee pain, [>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization] for > 14 days/month during 3 consecutive months preceding enrollment will be included in this randomized double-blind placebo-controlled trial. Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=72) or placebo (n=72) together with their usual therapy provided the dosages were kept constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability will also be assessed. Synovitis will be detected by ultrasound imaging.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
25mg oral methotrexate tablets
25 mg/week oral methotrexate tablets interventional drug
(Placebo Comparator)
25 mg/week placebo tablets
25mg/week oral placebo tablets

Primary Outcomes

pain reduction
time frame: 28 weeks

Secondary Outcomes

physical function improvement
time frame: 28 weeks

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - primary knee osteoarthritis - persistent pain - synovitis Exclusion Criteria: - rheumatoid arthritis - gout and pseudogout - traumatic arthritis - other secondary arthritis - renal disease - liver disease

Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Faculty of Medicine, University of Alexandria.