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Methotrexate in Symptomatic Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01654575
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Osteoarthritis Drug: Methotrexate Drug: Placebo

Study Design

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
Primary Completion Date : November 2011
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • any other inflammatory conditions,
  • hepatic and renal insufficiency
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01654575


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

Responsible Party: Anna Abou-Raya, Professor of Rheumatology, Faculty of Medicine, University of Alexandria
ClinicalTrials.gov 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, Faculty of Medicine, University of Alexandria:
Methotrexate
Knee Osteoarthritis
Synovitis
Pain reduction
Function scores

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors