Condition category
Musculoskeletal Diseases
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
16/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/#http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes