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Methotrexate in Symptomatic Knee Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Methotrexate
Placebo
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Methotrexate, Knee Osteoarthritis, Synovitis, Pain reduction, Function scores

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • any other inflammatory conditions,
  • hepatic and renal insufficiency

Sites / Locations

  • Faculty of Medicine, University of Alexandria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methotrexate

Placebo

Arm Description

25mg/week orally

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

Outcomes

Primary Outcome Measures

Pain reduction
Pain reduction

Secondary Outcome Measures

Improvement in physical function scores

Full Information

First Posted
July 26, 2012
Last Updated
July 28, 2012
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT01654575
Brief Title
Methotrexate in Symptomatic Knee Osteoarthritis
Official Title
Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Methotrexate, Knee Osteoarthritis, Synovitis, Pain reduction, Function scores

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate
Arm Type
Experimental
Arm Description
25mg/week orally
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Placebo-"sugar tablets" identical in colour and shape to methotrexate given once a week for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate 25mg/week for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets once a week for 16 weeks
Primary Outcome Measure Information:
Title
Pain reduction
Time Frame
4 months
Title
Pain reduction
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Improvement in physical function scores
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary knee osteoarthritis pain not responding to the usual therapy synovitis Exclusion Criteria: any other inflammatory conditions, hepatic and renal insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Abou-Raya, MD
Organizational Affiliation
University of Alexandria
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine, University of Alexandria
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

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Methotrexate in Symptomatic Knee Osteoarthritis

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