Psoriasis vulgaris MedDRA version: 12.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: no
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: # Chronic severe plaque type psoriasis (PASI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: # Allergies and/or Sensitivity to the IMP # Patients with malignoma or autoimmune disease or other severe impairment of health #Patients with active tuberculosis or other chronic, severe or opportunistic infections; patients with sepsis or positive tuberculosis screening #Patients with cardial insufficiency (NYHA Class III/IV) #Patients with gastroinestinal, hepatic, renal diseases, gastric/duodenal ulcers # Women of childbearing potential not taking contraceptive measures # Pregnant or breastfeeding women # Patients who are unable to understand or comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: While there is substantial evidence depicting psoriasis as a chronic inflammatory disease promoting diabetes and atherosclerosis, the influence of systemic antipsoriatic treatments on these comorbidities remains unclear. With the introduction of anti-TNF alpha blockers into psoriasis therapy, a new class of agents, which might attack several pathways leading to diabetes and cardiovascular disease(5), is at hand. Nevertheless, prospective data on the influence of antipsoriatic anti-TNF alpha blockers on these comorbities in psoriasis patients is lacking. Thus we would like to elucidate in our study, if long term treatment with the TNF alpha inhibitor Adalimumab can offer a perspective in controlling systemic inflammation and resulting metabolic and cardiovascular disease. ;Secondary Objective: Head to head comparison of a conventional and safe long term therapy for psoriasis against a novel TNF alpha blocker concerning efficacy and safety.;Primary end point(s): Primary outcome To observe the influence of anti psoriasis therapy with the TNF alpha antagonist Adalimumab on the functional integrity of the endothelium as measured by flow mediated dilatation (FMD). FMD is an ultrasound-based method, measuring arterial diameter in response to an increase in shear stress, which causes endothelium-dependent dilatation. Measurement of FMD is an established surrogate marker for artherosclerosis. FMD has been utilized in as primary read out in numerous clinical trials investigating various interventional strategies in cardiovascular disease. Secondary outcomes according to the main hypothesis of the trial include measurement of carotid artery intima ¬media thickness (IMT) by ultrasonography, blood sampling for determination of fasting glucose, oral glucose tolerance test, HbA1c, insulin and c-peptide; blood lipids (total cholesterol, LDL, HDL), IL-6, hsCRP, IL-1 beta(10), TNF alpha and adhesion molecules ICAM-1, VCAM-1 and E-Selectin. | — |
Countries
Austria
Outcome results
None listed