Der Einfluss von Adalimumab auf kardiovaskuläre und metabolische Risikofaktoren in der Therapie von Patienten mit mittelschwerer bis schwerer Psoriasis vulgaris im Vergleich zu einer Standardtherapie (Fumarsäureester) - CASTIP(Comorbidities and systemic therapies in psoriasis)

Phase 1

• Conditions: Psoriasis vulgaris; MedDRA version: 12.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2010-018369-48-AT
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-08
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

# Chronic severe plaque type psoriasis (PASI <10) requiring anti TNF alpha therapy; Contraindication or therapeutic failure of 2 conventional systemic treatments
# PASI = 10, BSA = 10
# Age 18 – 80 years

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

# 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified