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Completed

NCT Number: NCT00184886

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.

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Key information

Conditions

Methotrexate Aneurysm Cardiovascular Diseases Vascular Diseases Vasodilation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methotrexate 15 mg/week for 12 weeks

Drug

Primary outcomes

  1. Vasodilator response to infusion of adenosine and dipyridamole into the brachial artery

Secondary outcomes

  1. Adenosine deaminase activity

  2. CRP, BSE, DAS

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Feb 14, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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