Hand OA AND Methotrexate Use

NCT01927484 | Terminated DMC

• 1 other identifier: alexmed1391963211975
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Reduction in Pain; Reduction of Inflammation; Improvement in Function

Keywords

methotrexate,; osteoarthritis,; pain,; function,; synovitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• physical function improvement Functional assessment

  28 weeks

Other Outcomes (1)

• safety and tolerability

  28 weeks

Study Arms (2)

methotrexate

EXPERIMENTAL

25mg oral methotrexate tablets

Drug: 25 mg/week oral methotrexate tablets

placebo

PLACEBO COMPARATOR

25 mg/week placebo tablets

Drug: 25mg/week oral placebo tablets

Interventions

25 mg/week oral methotrexate tablets DRUG

active oral methotrexate drug

Also known as: interventional drug

methotrexate

25mg/week oral placebo tablets DRUG

placebo comparator oral drug

placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary knee osteoarthritis
• persistent pain
• synovitis

You may not qualify if:

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

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Medicine

Alexandria, 00203, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis; Pain; Synovitis

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 22, 2013
• Study Start: March 7, 2020
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

EG (1)