Methotrexate in Symptomatic Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Abou-Raya, Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier:
NCT01654575
First received: July 26, 2012
Last updated: July 28, 2012
Last verified: July 2012
  Purpose

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 Intervention
Osteoarthritis
Drug: Methotrexate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Using Methotrexate for Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Faculty of Medicine, University of Alexandria:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Pain reduction [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in physical function scores [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 88
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 26, 2012
Last Updated: July 28, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on July 23, 2014