MethotrexateNCT00184886
The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans
A study testing Methotrexate 15 mg/week for 12 weeks in people with Methotrexate and Vasodilation, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
In this study we aim to determine whether methotrexate influences the metabolism and vascular effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with potent anti-inflammatory effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Methotrexate, Vasodilation
- What is being tested?
- Methotrexate 15 mg/week for 12 weeks
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2003to Jan 2005
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 year
- polyarthritis
- DAS score > 2.5
Who cannot join
- previous use of MTX
- concomitant use of dipyridamole/sulfazalasine
- Alcohol > 21 U/week
- elevated liver enzymes
- pregnancy, breast-feeding, asthma, renal insufficiency, thrombocytopenia, leucocytopenia
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
In this study we aim to determine whether methotrexate influences the metabolism and vascular effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation, ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by adenosine receptor stimulation. In this study, we aim to determine whether also in humans in vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial artery is assessed as biomarker for the endogenous adenosine concentration.
Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn homocysteine.
- Conditions
- Methotrexate, Vasodilation
- Being tested
- Methotrexate 15 mg/week for 12 weeks
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate 15 mg/week for 12 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasodilator response to infusion of adenosine and dipyridamole into the brachial artery
Secondary outcomes (2)
Adenosine deaminase activity
CRP, BSE, DAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MethotrexateStudies of the same condition, open and under way.
- More trials run by Radboud University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Gerard Rongen, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184886
- Sponsor's protocol ID
- MTX-Ado
- Other IDs
- ZonMw Nr. 920-03-249
- Status last verified
- Feb 2006
- First submitted
- 12 Sep 2005
- Last updated
- 14 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans
- ClinicalTrials.gov ID
- NCT00184886
- Acronym / sponsor ID
- MTX-Ado
- Conditions
- Methotrexate, Vasodilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Nov 2003
- Study completion
- Jan 2005
- First posted
- 16 Sep 2005 (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.
In this study we aim to determine whether methotrexate influences the metabolism and vascular effects of adenosine in humans in vivo. Adenosine is an endogenous purine-nucleoside with potent anti-inflammatory effects. Also, adenosine receptor stimulation induces vasodilation, ischaemic preconditioning and many other cardiovacular effects. Previous animal studies have provided limited evidence that the anti-inflammatory effects of methotrexate are mediated by adenosine receptor stimulation. In this study, we aim to determine whether also in humans in vivo, methotretate influences endogenous adenosine. Therefore, 10 patients with inflammatory arthritis are treated with methotretxae (15 mg/week orally) for 12 weeks. Before and after treatment, vasodilation to the infusion of adenosine and dipyridamole into the brachial artery is assessed as biomarker for the endogenous adenosine concentration.
Also, blood is drawn for the determination of CRP, ESR, Adenosine deaminase activity adn homocysteine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 year
- polyarthritis
- DAS score > 2.5
Key exclusion criteria (5 listed)
- previous use of MTX
- concomitant use of dipyridamole/sulfazalasine
- Alcohol > 21 U/week
- elevated liver enzymes
- pregnancy, breast-feeding, asthma, renal insufficiency, thrombocytopenia, leucocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate 15 mg/week for 12 weeks | Drug | – |
Primary outcome
Vasodilator response to infusion of adenosine and dipyridamole into the brachial artery
2 secondary outcomes
Adenosine deaminase activity
CRP, BSE, DAS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2006.
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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.
Gerard Rongen, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate 15 mg/week for 12 weeks in people with Methotrexate and Vasodilation, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Vasodilator response to infusion of adenosine and dipyridamole into the brachial artery. It is what the study was designed to measure, not a finding.
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 14 Feb 2006.