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The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate

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ClinicalTrials.gov Identifier: NCT00464997
Recruitment Status : Unknown
Verified April 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2007
Last Update Posted : April 24, 2007
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
High dose aspirin have been shown to increase the level of Methotrexat in patients with Rheumatoid Arthritis. However, most of RA patients are not currently treated with high dose aspirin. On the other hand, they frequently receive treatment with low dose aspirin. The effect of low dose aspirin on the levels of Methotrexate is not well known. Therefore,the purpose of this study is to assess the effect of low dose aspirin on the levels of methotrexate.

Condition or disease
Rheumatoid Arthritis

Detailed Description:

Thirty Rheumatoid Arthritis patients currently treated with low dose methotrexate (MTX) will participate in this study. On the day of intake of methotrexate, the patients will receive 10 mg of MTX. Serum levels of MTX will be measured at time 0,30 ,90, 120 minutes, and after 12 and 24 hours.

Two weeks later, the patients will be recommended to take 100 mg aspirin/d during a week. The levels of MTX will be measured after a week of treatment in a way similar to a week before.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate
Study Start Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • RApatients treated with Methotrexate

Exclusion Criteria:

  • Contraindication to aspirin

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): NCT00464997

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Ori Elkayam, M.D Tel Aviv Medical Center

ClinicalTrials.gov Identifier: NCT00464997     History of Changes
Other Study ID Numbers: TASMC-07-OE-156-CTIL
First Posted: April 24, 2007    Key Record Dates
Last Update Posted: April 24, 2007
Last Verified: April 2007

Keywords provided by Tel-Aviv Sourasky Medical Center:
methotrexate aspirin pharmacokinetics

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System 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
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents