Effect of anti-TNF-alpha therapy on endothelial progenitor cells and endothelial dysfunction in patients with psoriasis without risk factors for atherosclerosis - EPPSOR-Studie

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011397-14-DE

Enrollment

Registered

2009-08-11

Start date

2009-12-07

Completion date

Unknown

Last updated

2022-08-08

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

Conditions

Psoriasis vulgaris

Interventions

Trade Name: Enbrel Product Name: enbrel Pharmaceutical Form: Solution for injection INN or Proposed INN: ETANERCEPT CAS Number: 185243690 Concentration unit: mg/ml milligram(s)/millilitre Concentratio

Eligibility

Inclusion criteria

Inclusion criteria: - Patients aged between 18 and 50 years. The aim of this age restiction is to emphasize that the study population is propably not affected by common arteriosclerosis because of their age. - Moderate to severe chronic plaque psoriasis (PASI = 10, BSA = 10, DLQI = 10) - Indication for therapy with etanercept Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Conventional cardiovascular risk factors - Contraindication for etanercept, accordingly to the approved guidelines

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the impact of inflammation on vascular disease in patients affected by psoriasis before and during anti-TNF alpha based therapy for controlling the inflammatory activity. We are especially interested in the following questions: 1. Is there a degree of endothelial dysfunction in otherwise healthy patients with psoriasis? 2. If yes, is this associated with dysfunction of endothelial progenitor cells? 3. Which influence has an anti-inflammatory therapy with etanercept in this context? 4. Which molecular mechanisms are responsible for both endothelial – and EPC dysfunction? ;Secondary Objective: ;Primary end point(s): Rationale: In a cohort of thirteen young patients with rheumatoid arthritis we demonstrated early endothelial dysfunction which was associated with an impairment of important functional features of endothelial progenitor cells [8]. Patients with psoriasis are in a comparable inflammatory state. Therefore we suppose similar alterations.	—

Measure

Time frame

Main Objective: To determine the impact of inflammation on vascular disease in patients affected by psoriasis before and during anti-TNF alpha based therapy for controlling the inflammatory activity. We are especially interested in the following questions: 1. Is there a degree of endothelial dysfunction in otherwise healthy patients with psoriasis? 2. If yes, is this associated with dysfunction of endothelial progenitor cells? 3. Which influence has an anti-inflammatory therapy with etanercept in this context? 4. Which molecular mechanisms are responsible for both endothelial – and EPC dysfunction? ;Secondary Objective: ;Primary end point(s): Rationale: In a cohort of thirteen young patients with rheumatoid arthritis we demonstrated early endothelial dysfunction which was associated with an impairment of important functional features of endothelial progenitor cells [8]. Patients with psoriasis are in a comparable inflammatory state. Therefore we suppose similar alterations.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026