Rheumatoid ArthritisNCT00464997
The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate
An observational study of Rheumatoid Arthritis, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RApatients treated with Methotrexate
Who cannot join
- Contraindication to aspirin
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- methotrexate aspirin pharmacokinetics
- Medical subject headings
- Arthritis, Rheumatoid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Ori Elkayam, M.D, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464997
- Sponsor's protocol ID
- TASMC-07-OE-156-CTIL
- Status last verified
- Apr 2007
- First submitted
- 23 Apr 2007
- Last updated
- 24 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate
- ClinicalTrials.gov ID
- NCT00464997
- Acronym / sponsor ID
- TASMC-07-OE-156-CTIL
- Conditions
- Rheumatoid Arthritis
- Keywords
- methotrexate aspirin pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2007
- First posted
- 24 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- RApatients treated with Methotrexate
Key exclusion criteria (1 listed)
- Contraindication to aspirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ori Elkayam, M.D principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2007.