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Trial record 8 of 9 for:    "Synovitis" | "Folic Acid"

Methotrexate in Symptomatic Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01654575
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
Anna Abou-Raya, University of Alexandria

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Methotrexate Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis
Study Start Date : July 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Methotrexate
25mg/week orally
Drug: Methotrexate
Methotrexate 25mg/week for 16 weeks

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

Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 4 months ]
  2. Pain reduction [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Improvement in physical function scores [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • any other inflammatory conditions,
  • hepatic and renal insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01654575

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Faculty of Medicine, University of Alexandria
Alexandria, Egypt
Sponsors and Collaborators
University of Alexandria
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Study Director: Anna Abou-Raya, MD University of Alexandria

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Responsible Party: Anna Abou-Raya, Professor of Rheumatology, University of Alexandria Identifier: NCT01654575     History of Changes
Other Study ID Numbers: alexmed116662981
First Posted: August 1, 2012    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012
Keywords provided by Anna Abou-Raya, University of Alexandria:
Knee Osteoarthritis
Pain reduction
Function scores
Additional relevant MeSH terms:
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Folic Acid Antagonists
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors