The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00184886
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development (Other)
• Enrollment: 10
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Methotrexate; Vasodilation	Drug: Methotrexate 15 mg/week for 12 weeks	N/A

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Influence of Methotrexate on the Metabolism and Vascular Effects of Adenosine in Humans
• Study Start Date: Nov 1, 2003
• Study Completion Date: Jan 1, 2005

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Adenosine deaminase activity []

2. CRP, BSE, DAS []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Nijmegen Medical Centre	Nijmegen		Netherlands	6500HB

Sponsors and Collaborators

• Radboud University Medical Center
• ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

• Principal Investigator: Gerard Rongen, MD, PhD, Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00184886
• Other Study ID Numbers: MTX-Ado; ZonMw Nr. 920-03-249
• First Posted: Sep 16, 2005
• Last Update Posted: Feb 14, 2006
• Last Verified: Feb 1, 2006

• Additional relevant MeSH terms: Methotrexate

Study Results

No Results Posted as of Feb 14, 2006