Hand OA AND Methotrexate Use

Not Applicable

Terminated

• Conditions: Reduction of Inflammation; Improvement in Function; Reduction in Pain
• Interventions: Drug: 25mg/week oral placebo tablets; Drug: 25 mg/week oral methotrexate tablets

• Registration Number: NCT01927484
• Lead Sponsor: University of Alexandria

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-22
• Study Start: 2020-03-07
• Primary Completion: 2020-03-11
• Study Completion: 2020-03-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• primary knee osteoarthritis
• persistent pain
• synovitis

Exclusion Criteria

• rheumatoid arthritis
• gout and pseudogout
• traumatic arthritis
• other secondary arthritis
• renal disease
• liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	25mg/week oral placebo tablets	25 mg/week placebo tablets
methotrexate	25 mg/week oral methotrexate tablets	25mg oral methotrexate tablets

Primary Outcome Measures

Name	Time	Method
pain reduction	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.

Secondary Outcome Measures

Name	Time	Method
physical function improvement Functional assessment	28 weeks	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.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Alexandria, Egypt