Knee Osteoarthritis AND Methotrexate Use
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|ClinicalTrials.gov Identifier: NCT01927484|
Recruitment Status : Unknown
Verified August 2013 by Anna Abou-Raya, University of Alexandria.
Recruitment status was: Active, not recruiting
First Posted : August 22, 2013
Last Update Posted : August 22, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Reduction in Pain Reduction of Inflammation Improvement in Function||Drug: 25 mg/week oral methotrexate tablets Drug: 25mg/week oral placebo tablets||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||September 2013|
25mg oral methotrexate tablets
Drug: 25 mg/week oral methotrexate tablets
Other Name: interventional drug
Placebo Comparator: placebo
25 mg/week placebo tablets
Drug: 25mg/week oral placebo tablets
- pain reduction [ Time Frame: 28 weeks ]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.
- physical function improvement [ Time Frame: 28 weeks ]Improvements in physical functioning will be assessed using the Western Ontario and 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.
- safety and tolerability [ Time Frame: 28 weeks ]Safety and tolerability to treatment will be assessed at each visit. Safety will be assessed by identifying adverse events using open-ended questions and a checklist including common oral methotrexate side effects, physical examination and by laboratory assessment including complete blood picture and liver enzymes. Adverse events will be collected at each visit and up to 28 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927484
|Faculty of Medicine|
|Alexandria, Egypt, 00203|