TUmor Necrosis factor blockaDe in patients with Rheumatoid Arthritis inhibits atherothrombosis
ISRCTN | ISRCTN26286159 |
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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
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 |
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s.i.vanleuven@amc.uva.nl |
Study information
Study design | This is an observational study in RA patients undergoing therapy with TNF-alpha blockade |
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Primary study design | Observational |
Secondary study design | Single-centre |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/01/2006 |
Completion date | 31/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 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
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Website | http://www.amc.uva.nl/#http://www.amc.uva.nl/ |
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https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |