EUCTR2005-000480-25-FI
Active, not recruiting
Not Applicable
Classification and characterization of patient suffering from moderate to severe plaque psoriasis responding to subcutaneous administered efalizumab - ROCAC
Investigator Trondheim Hudlegesenter AS0 sites150 target enrollmentStarted: June 19, 2006Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Investigator Trondheim Hudlegesenter AS
- Enrollment
- 150
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •The study population consists of patients of both genders, over the age of 18 years who have been suffering from stable moderate to severe plaque psoriasis for more than six months and who are eligible for efalizumab treatment according to current national guidelines, i.e. the patients have not responded to, have contraindications to or are intolerant to other systemic treatment, including cyklosporin, methotrexat and PUVA.
- •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) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\* Pregnant or breast\-feeding patients.
- •\* Patients with a history of uncontrolled bacterial, viral, fungal or atypical mycobacterial infection.
- •\* Patients suffering from HIV, hepatitis B and C, active tuberculosis (TB) or currently undergoing treatment for TB, hepatic cirrhosis and hospital admission for cardiac disease, stroke or pulmonary disease within last year.
- •\* Patients with history of cancer in the preceding 5 years, including lymphproliferative disorders. Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
- •\* Patients to whom subcutaneous administered efalizumab treatments are contraindicated.
Investigators
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