Interruption of TNFinhibitors and Endothelial Function
POET-VEF
The Effect of Interruption of TNFi on Endothelial Function in Patients With Rheumatoid Arthritis
1 other identifier
observational
48
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2012
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 8, 2013
CompletedFirst Posted
Study publicly available on registry
May 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 2, 2014
April 1, 2014
2.2 years
January 8, 2013
May 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
TNFi withdrawal and response to nitroprusside
6 months
VCAM and SCAM
6 months
Study Arms (2)
Stop
Patients with stable RA stopping TNF inhibition
Continue
Patients with stable RA continuing TNFi therapy
Eligibility Criteria
Patients with stable rheumatoid arthritis who are included in another study (POEET) to stop or continue their TNFi therapy.
You may qualify if:
- Informed consent for POEET trial and this additional study
- On stable medication (except for TNFi-therapy)
You may not qualify if:
- Uncontrolled hypertension (RR \> 140/90 mmHg average of three measurements at screening after 5 minutes of supine rest)
- Diabetes mellitus
- Heart failure or any other cardiovascular disease that is expected to induce changes in cardiovascular medication during the study period.
- Expected to start or change medication that can alter endothelial function (lipid lowering drugs, blood pressure lowering drugs, NSAIDs, immunosuppressive therapy other than TNFi drugs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29307093DERIVED
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof dr G Rongen
Study Record Dates
First Submitted
January 8, 2013
First Posted
May 2, 2014
Study Start
September 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 2, 2014
Record last verified: 2014-04