Skip to content

Effect of interruption of TNFi on endothelial function in patients with rheumatoid arthritis

Effect of interruption of TNFi on endothelial function in patients with rheumatoid arthritis - POEET- VEF (endothelial substudy)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37380
Enrollment
48
Registered
2012-08-09
Start date
2013-02-16
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

reumatoide artritis

Interventions

Intra-arterial infliximab 20 microgram/dl forearm volume /min during 80 minutes, during venous occlusion plethysmography

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: a. Informed consent for POEET trial and this additional study;b. On stable medication (except for TNFi-therapy)

Exclusion criteria

Exclusion criteria: a. Uncontrolled hypertension (RR > 140/90 mmHg average of three measurements at screening after 5 minutes of supine rest);b. Diabetes mellitus;c. Heart failure or any other cardiovascular disease that is expected to induce changes in cardiovascular medication during the study period.;d. 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)

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Secondary endpoints are the effect of TNFi-withdrawal on circulating VCAM and ICAM Secondary endpoints are The the interaction between TNFi-withdrawal and the vasodilator response to nitroprusside (expressed as difference in FBF between the withdrawal group and the continuing group). The response to SNP serves as an internal vasodilator control to assess potential endothelium-independent effects of TNFi-withdrawal on the response to acetylcholin.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)