Hand OA AND Methotrexate Use (Hand OA & MTX)

Methotrexate in Hand Osteoarthritis

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 00203
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: methotrexate; 25mg oral methotrexate tablets	Drug: 25 mg/week oral methotrexate tablets; active oral methotrexate drug; Other Names: interventional drug
PLACEBO_COMPARATOR: placebo; 25 mg/week placebo tablets	Drug: 25mg/week oral placebo tablets; placebo comparator oral drug

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and tolerability	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.	28 weeks

Collaborators and Investigators

• Sponsor: University of Alexandria

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2020
• Primary Completion (ACTUAL): March 11, 2020
• Study Completion (ACTUAL): March 11, 2020

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (ESTIMATE): August 22, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: methotrexate,; synovitis; pain,; osteoarthritis,; function,
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID Numbers: alexmed1391963211975

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No