Methorexate and Knee Osteoarthritis

Sponsor

University of Alexandria (Other)

Overall Status

Completed

CT.gov ID

NCT04326894

Collaborator

(none)

128

Enrollment

Location

Arms

Actual Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pain Reduction Physical Function Improvement	Drug: 25 mg/week oral methotrexate tablets Drug: 25mg/week oral placebo tablets	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Actual Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methotrexate 25mg oral MTX tablets	Drug: 25 mg/week oral methotrexate tablets Other Names: interventional drug
Placebo Comparator: Placebo 25 mg/week placebo tablets	Drug: 25mg/week oral placebo tablets

Arm

Intervention/Treatment

Experimental: Methotrexate

25mg oral MTX tablets

Drug: 25 mg/week oral methotrexate tablets

Other Names:

interventional drug

Placebo Comparator: Placebo

25 mg/week placebo tablets

Drug: 25mg/week oral placebo tablets

Outcome Measures

Primary Outcome Measures

Pain reduction [8 months]
The primary outcome measure was pain reduction.Pain was assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm).

Secondary Outcome Measures

Physical function improvement [8 months]
Functional assessment was performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

primary knee osteoarthritis
synovitis
pain

Exclusion Criteria:

other inflammatory conditions
hepatic insufficiency
renal insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Alexandria		Egypt	00203

Sponsors and Collaborators

University of Alexandria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna Abou-Raya, MD, University of Alexandria

ClinicalTrials.gov Identifier:

NCT04326894

Other Study ID Numbers:

alexmed1391963211966

First Posted:

Mar 30, 2020

Last Update Posted:

Mar 30, 2020

Last Verified:

Mar 1, 2020

Keywords provided by Anna Abou-Raya, MD, University of Alexandria

methotrxate, knee osteoarthritis, inflammation, pain, function

Additional relevant MeSH terms:

Osteoarthritis

Methotrexate

Study Results

No Results Posted as of Mar 30, 2020