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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR837 |
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Date of registration:
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12/12/2006 |
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Primary sponsor: |
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Public title:
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Tumor Necrosis Factor blockade in patients with Rheumatoid Arthritis inhibits Atherothrombosis.
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Scientific title:
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Tumor Necrosis Factor blockade in patients with Rheumatoid Arthritis inhibits Atherothrombosis. - TUNDRA |
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Date of first enrolment:
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1/1/2006 |
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Target sample size:
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15 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=837 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: Single; Control: Not applicable; Group: Factorial; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Sander
Leuven, van |
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Address:
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Academic Medical Center (AMC), Department of Vascular Medicine, room F4-159.2,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5668675 |
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Email:
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s.i.vanleuven@amc.uva.nl |
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Affiliation:
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Name:
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Sander
Leuven, van |
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Address:
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Academic Medical Center (AMC), Department of Vascular Medicine, room F4-159.2,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5668675 |
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Email:
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s.i.vanleuven@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male or female patients who were priorly diagnosed with RA, who are currently experiencing an inflammatory episode and who will be treated with TNF-alpha blockade;
2. Age 18-80 years.
Exclusion criteria: 1. Patients who were priorly diagnosed with diabetes, hypertension or cardiovascular disease;
2. Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Rheumatoid arthritis
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Intervention(s)
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TNF-alpha blockade.
(patients are their own control)
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Primary Outcome(s)
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1. Endothelial Function (FMD);
2. Glycocalyx;
Before treatment, 0-4 weeks after treatment, 9-12 weeks after treatment.
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Secondary Outcome(s)
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1. Atherosclerosis:
Plasma: Total cholesterol, LDL, HDL, Triglycerides, Lp(a), ox-LDL;
2. Thrombosis:
D-dimer, F1+2, sTF, PAI-I;
3. Inflammation:
IL-1beta, TNF-alpha, IL-6, IL-8, IL-10, hsCRP.
Before treatment, 0-4 weeks after treatment, 9-12 weeks after treatment.
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Secondary ID(s)
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ISRCTN26286159
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N/A
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Source(s) of Monetary Support
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Academic Medical Center (AMC), Department of Vascular Medicine
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