Methorexate and Knee Osteoarthritis

NCT04326894 | Completed Phase 4 DMC

• 1 other identifier: alexmed1391963211966
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.Synovial inflammation and proliferation has emerged as a key component of OA and as a potential predictor of worsening disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate (MTX) in decreasing pain and inflammation in symptomatic knee OA. 128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited. Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores. Keywords: methotrexate knee osteoarthritis inflammation pain reduction physical funtion

Conditions

Pain Reduction; Physical Function Improvement

Keywords

methotrxate, knee osteoarthritis, inflammation, pain, function

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  The primary outcome measure was pain reduction.Pain was assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm).

  8 months

Secondary Outcomes (1)

• Physical function improvement

  8 months

Study Arms (2)

Methotrexate

EXPERIMENTAL

25mg oral MTX 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

Also known as: interventional drug

Methotrexate

25mg/week oral placebo tablets DRUG

Placebo

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary knee osteoarthritis
• synovitis
• pain

You may not qualify if:

• other inflammatory conditions
• hepatic insufficiency
• renal insufficiency

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Faculty of Medicine

Alexandria, 00203, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Inflammation; Pain

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; 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: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: March 30, 2020
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

EG (1)