TUmor Necrosis factor blockaDe in patients with Rheumatoid Arthritis inhibits atherothrombosis

ISRCTN	ISRCTN26286159
DOI	https://doi.org/10.1186/ISRCTN26286159
Protocol serial number	N/A
Sponsor	Academic Medical Center (AMC) (The Netherlands)
Funder	Academic Medical Center (AMC) (The Netherlands)

Submission date: 16/01/2007
Registration date: 16/01/2007
Last edited: 16/01/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sander van Leuven
Scientific

Academic Medical Center (AMC)
Department of Vascular Medicine
Room F4-159.2
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 8675
Email	s.i.vanleuven@amc.uva.nl

Study information

Primary study design	Observational
Study design	This is an observational study in RA patients undergoing therapy with TNF-alpha blockade
Secondary study design	Single-centre
Scientific title
Study acronym	TUNDRA
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Rheumatoid arthritis
Intervention	TNF-alpha blockade (patients are their own control).
Intervention type	Other
Primary outcome measure(s)	1. Endothelial Function (Flow-Mediated Dilation [FMD]) 2. Glycocalyx Before treatment, zero to four weeks after treatment, nine to 12 weeks after treatment.
Key secondary outcome measure(s)	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.
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	15
Key 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
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan