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Methotrexate in Symptomatic Knee Osteoarthritis

NCT ID: NCT01654575

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

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Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists.Synovitis is commonly demonstrated in knee OA imaging. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.Accordingly,the aim of the present study was to assess the efficacy of MTX in decreasing pain and inflammation.Eighty-eight patients with clinical and radiographic criteria of primary knee OA with knee pain, were included in this study.Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX(n=44)or placebo(n=44)for 16 weeks. The primary outcome measure was pain reduction and secondary outcome measures included improvements in physical function scores.There was a statistically significant reduction in pain and improvement in function in the MTX group compared to the placebo group at 16 weeks.

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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Methotrexate Knee Osteoarthritis Synovitis Pain reduction Function scores

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methotrexate

25mg/week orally

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Methotrexate 25mg/week for 16 weeks

Placebo

Placebo-"sugar tablets" identical in colour and shape to methotrexate given once a week for 16 weeks.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets once a week for 16 weeks

Interventions

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Methotrexate

Methotrexate 25mg/week for 16 weeks

Intervention Type DRUG

Placebo

Placebo tablets once a week for 16 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* primary knee osteoarthritis
* pain not responding to the usual therapy
* synovitis

Exclusion Criteria

* any other inflammatory conditions,
* hepatic and renal insufficiency
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Anna Abou-Raya

Professor of Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Abou-Raya, MD

Role: STUDY_DIRECTOR

University of Alexandria

Locations

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Faculty of Medicine, University of Alexandria

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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alexmed116662981

Identifier Type: -

Identifier Source: org_study_id