Contact information
Type
Scientific
Primary contact
Dr Sander van Leuven
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Vascular Medicine
Room F4-159.2
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 8675
s.i.vanleuven@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
TUNDRA
Study hypothesis
In the current study we aim to establish whether Tumor Necrosis Factor (TNF)-alpha plays a central role in inflammation-mediated acceleration of atherogenesis and the propencity towards development of atherothrombotic disease in Rheumatoid Arthritis (RA).
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
This is an observational study in RA patients undergoing therapy with TNF-alpha blockade
Primary study design
Observational
Secondary study design
Single-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
TNF-alpha blockade (patients are their own control).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Endothelial Function (Flow-Mediated Dilation [FMD])
2. Glycocalyx
Before treatment, zero to four weeks after treatment, nine to 12 weeks after treatment.
Secondary outcome measures
1. Atherosclerosis: Plasma:
a. total cholesterol
b. Low Density Lipoproteins [LDL]
c. High Density Lipoproteins [HDL]
d. Triglycerides
e. Lipoprotein a [Lp(a)]
f. oxidised LDL
2. Thrombosis:
1. D-dimer
2. prothrombin fragment 1 and 2 (F1+2)
3. soluble Tissue Factor (sTF)
4. Plasminogen Activator Inhibitor type 1 (PAI-1)
3. Inflammation:
a. InterLeukin-1beta (IL-1beta)
b. TNF-alpha
c. InterLeukin 6 (IL-6)
d. InterLeukin-8 (IL-8)
e. Interleukin 10 (IL-10)
f. high-sensitivity C-Reactive Protein (hsCRP)
Before treatment, zero to four weeks after treatment, nine to 12 weeks after treatment.
Overall trial start date
01/01/2006
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant 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 to 80 years
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
15
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Center (AMC) (The Netherlands)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary