Classification and characterization of patient suffering from moderate to severe plaque psoriasis responding to subcutaneous administered efalizumab - ROCAC

• Conditions: Plaque psoriasis; MedDRA version: 4.0Level: LLTClassification code 10050577

• Registration Number: EUCTR2005-000480-25-FI
• Lead Sponsor: Investigator Trondheim Hudlegesenter AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To classify patients suffering from plaque psoriasis responding to a given treatment based upon reduction in Psoriasis Area and Severity Index (PASI), Psoriasis Disability Index (PDI) and Dermatology Life Quality Index (DLQI). ;Secondary Objective: * Characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administered efalizumab treatment. <br>* Estimate time until response of subcutaneous administered efalizumab treatment in patients suffering from plaque psoriasis. <br>* Estimate the prevalence and the time until exacerbation of symptoms in patients classified as responders to subcutaneous administered efalizumab treatment for plaque psoriasis.<br>;Primary end point(s): The three basic variables in the project are PASI, PDI and DLQI. Based on the PASI registration, PASI-25, 50 and 75 will be recorded and the patient classified as non-responder, possible responder or responder to the given treatment.