NCT02130076|UnknownDMC
Interruption of TNFinhibitors and Endothelial Function
POET-VEF
The Effect of Interruption of TNFi on Endothelial Function in Patients With Rheumatoid Arthritis
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POET-VEF
The Effect of Interruption of TNFi on Endothelial Function in Patients With Rheumatoid Arthritis
Sponsor study identifier
observational
48
0 countries
N/A
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Patients with rheumatoid arthritis (RA) have an increased risk of cardiovascular events. This increased risk is thought to be driven by inflammation-induced endothelial dysfunction, an initial step in atherogenesis. Treatment with TNFalpha inhibitors (TNFi) improve endothelial function in patients with RA. Discontinuation of TNFi could therefore worsen endothelial function even in the absence of recurrence of systemic inflammation or reactivation of arthritis. If stopping TNFi results in worsening of endothelial function this would strongly suggest a higher cardiovascular risk in association with TNFi-wthdrawal
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 8, 2013
Actual (reported)May 2, 2014
Actual (reported)December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Response to acetylcholine
The primary endpoint is the interaction between TNFi-withdrawal and the vasodilator response to acetylcholine expressed as difference in FBF between the withdrawal group and the continuing group.
6 months
TNFi withdrawal and response to nitroprusside
6 months
VCAM and SCAM
6 months
Patients with stable RA stopping TNF inhibition
Patients with stable RA continuing TNFi therapy
Patients with stable rheumatoid arthritis who are included in another study (POEET) to stop or continue their TNFi therapy.
Rongen GA, van Ingen I, Kok M, Vonkeman H, Janssen M, Jansen TL. Vasodilator function worsens after cessation of tumour necrosis factor inhibitor therapy in patients with rheumatoid arthritis only if a flare occurs. Clin Rheumatol. 2018 Apr;37(4):909-916. doi: 10.1007/s10067-017-3961-6. Epub 2018 Jan 7.
First Submitted
January 8, 2013
First Posted
May 2, 2014
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Blood Vessel Study
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 2, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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