Methotrexate in Symptomatic Knee Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Methotrexate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Methotrexate, Knee Osteoarthritis, Synovitis, Pain reduction, Function scores
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
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
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
Learn more about this trial
Methotrexate in Symptomatic Knee Osteoarthritis
We'll reach out to this number within 24 hrs