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The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: April 23, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
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.

Rheumatoid Arthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 30
Study Start Date: June 2007
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.


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
  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 identifier: NCT00464997

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Ori Elkayam, M.D Tel Aviv Medical Center
  More Information Identifier: NCT00464997     History of Changes
Other Study ID Numbers: TASMC-07-OE-156-CTIL
Study First Received: April 23, 2007
Last Updated: April 23, 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 processed this record on August 16, 2017