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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Methotrexate Vasodilation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Methotrexate 15 mg/week for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Gerard Rongen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ZonMw Nr. 920-03-249

Identifier Type: -

Identifier Source: secondary_id

MTX-Ado