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

Knee Osteoarthritis AND Methotrexate Use

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ClinicalTrials.gov Identifier: NCT01927484
Recruitment Status : Unknown
Verified August 2013 by Anna Abou-Raya, University of Alexandria.
Recruitment status was:  Active, not recruiting
First Posted : August 22, 2013
Last Update Posted : August 22, 2013
Sponsor:
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. Synovial inflammation due to the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.

The aim of the present study is to assess the efficacy of MTX in decreasing pain and inflammation in symptomatic knee OA.

Methods: One hundred and forty-four patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with knee pain, [>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization] for > 14 days/month during 3 consecutive months preceding enrollment will be included in this randomized double-blind placebo-controlled trial. Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=72) or placebo (n=72) together with their usual therapy provided the dosages were kept constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability will also be assessed. Synovitis will be detected by ultrasound imaging.


Condition or disease Intervention/treatment Phase
Reduction in Pain Reduction of Inflammation Improvement in Function Drug: 25 mg/week oral methotrexate tablets Drug: 25mg/week oral placebo tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: methotrexate
25mg oral methotrexate tablets
Drug: 25 mg/week oral methotrexate tablets
Other Name: interventional drug

Placebo Comparator: placebo
25 mg/week placebo tablets
Drug: 25mg/week oral placebo tablets



Primary Outcome Measures :
  1. pain reduction [ Time Frame: 28 weeks ]
    The primary outcome will be pain reduction at 28 weeks compared to baseline using a Visual Analogue Pain Scale (VAS) 0-100 mm. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline.


Secondary Outcome Measures :
  1. physical function improvement [ Time Frame: 28 weeks ]
    Improvements in physical functioning will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscores for pain, stiffness and function , the patient global assessment of the severity of knee OA measured on a 0-100 mm VAS. The physician-reported disease activity VAS was also recorded. Data will be collected at baseline and monthly up to 28 weeks to determine any change in results from those obtained at baseline.


Other Outcome Measures:
  1. safety and tolerability [ Time Frame: 28 weeks ]
    Safety and tolerability to treatment will be assessed at each visit. Safety will be assessed by identifying adverse events using open-ended questions and a checklist including common oral methotrexate side effects, physical examination and by laboratory assessment including complete blood picture and liver enzymes. Adverse events will be collected at each visit and up to 28 weeks.



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

Inclusion Criteria:

  • primary knee osteoarthritis
  • persistent pain
  • synovitis

Exclusion Criteria:

  • rheumatoid arthritis
  • gout and pseudogout
  • traumatic arthritis
  • other secondary arthritis
  • renal disease
  • liver disease

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): NCT01927484


Locations
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Egypt
Faculty of Medicine
Alexandria, Egypt, 00203
Sponsors and Collaborators
University of Alexandria

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Responsible Party: Anna Abou-Raya, MD, University of Alexandria
ClinicalTrials.gov Identifier: NCT01927484     History of Changes
Other Study ID Numbers: alexmed1391963211975
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013
Keywords provided by Anna Abou-Raya, University of Alexandria:
methotrexate,
osteoarthritis,
pain,
function,
synovitis
Additional relevant MeSH terms:
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Folic Acid Antagonists
Inflammation
Pathologic Processes
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
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors