Hand OA AND Methotrexate Use

Study Overview
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Brief Summary
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Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists. Synovitis has been demonstrated in hand 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 hand OA. Methods: One hundred and twenty patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with hand 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=60) or placebo (n=60) 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.

Official Title
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Methotrexate in Hand Osteoarthritis

Conditions
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Reduction in Pain, Reduction of Inflammation, Improvement in Function

Intervention / Treatment
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* Drug: 25 mg/week oral methotrexate tablets
* Drug: 25mg/week oral placebo tablets


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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methotrexate<br>25mg oral methotrexate tablets | Drug: 25 mg/week oral methotrexate tablets<br>* active oral methotrexate drug<br>* Other names: interventional drug;|
| Placebo Comparator: placebo<br>25 mg/week placebo tablets | Drug: 25mg/week oral placebo tablets<br>* placebo comparator oral drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain reduction | The primary outcome will be pain reduction at 28 weeks compared to baseline using a Visual Analogue Pain Scale (VAS) 0-100 mm. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline. | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function improvement Functional assessment | Improvements in physical functioning McMaster Universities Osteoarthritis Index (WOMAC) subscores for pain, stiffness and function , the patient global assessment of the severity of knee OA measured on a 0-100 mm VAS. The physician-reported disease activity VAS was also recorded. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline. | 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methotrexate,, osteoarthritis,, pain,, function,, synovitis