The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans
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...
Brief Summary
Official Title: “The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans”
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 Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Methotrexate 15 mg/week for 12 weeks
Outcome Measures for this Clinical Trial
Primary Measures
- Vasodilator response to infusion of adenosine and dipyridamole into the brachial artery
Secondary Measures
- Adenosine deaminase activity
- CRP, BSE, DAS
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 18-75 year
- polyarthritis
- DAS score > 2.5
Exclusion Criteria:
- previous use of MTX
- concomitant use of dipyridamole/sulfazalasine
- Alcohol > 21 U/week
- elevated liver enzymes
- pregnancy, breast-feeding, asthma, renal insufficiency, thrombocytopenia, leucocytopenia
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Radboud University Other
Overall Clinical Trial Officials and Contacts
Gerard Rongen, MD, PhD Principal Investigator Radboud University
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00184886
Study ID Number: MTX-Ado
ClinicalTrials.gov Identifier: NCT00184886
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00184886
