TUmor Necrosis factor blockaDe in patients with Rheumatoid Arthritis inhibits atherothrombosis

ISRCTN ISRCTN26286159
DOI https://doi.org/10.1186/ISRCTN26286159
Secondary identifying numbers N/A
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

Study designThis is an observational study in RA patients undergoing therapy with TNF-alpha blockade
Primary study designObservational
Secondary study designSingle-centre
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymTUNDRA
Study objectivesIn 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) studiedRheumatoid arthritis
InterventionTNF-alpha blockade (patients are their own control).
Intervention typeOther
Primary outcome measure1. Endothelial Function (Flow-Mediated Dilation [FMD])
2. Glycocalyx

Before treatment, zero to four weeks after treatment, nine to 12 weeks after treatment.
Secondary outcome measures1. 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 study start date01/01/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants15
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl/#http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)
Alternative name(s)
Academic Medical Center, AMC
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan