Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00184366
• Other study ID #: ROCAC
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 18, 2012
• Start date: May 2005
• Est. completion date: July 2008

Study information

• Verified date: January 2012
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial Summary

The main objectives of the project are:

• To classify patients suffering from plaque psoriasis responding on a given treatment (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI)

• To characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administrated efalizumab.

Description:

This is an investigator initiated,prospective, longitudinal, observation study. Before starting treatment with efalizumab we will record factors such as demographic data, type of psoriasis, previous treatment, other diseases etc.

We will follow the patients and classify them as responders and non-responders. We hope to find 4-5 factors which we can use later to predict response of this drug.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• moderate to severe plaque psoriasis for more than six months

• eligible for efalizumab treatment according to current Norwegian guidelines

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 or C, active tuberculosis, 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 lymphoproliferative disorders. patients with history of fully resolved basal cell or squamous cell skin cancer may be enrolled.

• Patients with impaired renal or hepatic function.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• efalizumab
efalizumab

Locations

Country	Name	City	State
Norway	Dep of dermatology, St Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response PASI 75		2 years	No
Secondary	Dermatology Life Quality index (DLQI)		2 years	No
Secondary	Psoriasis disability Index (PDI)		2 years	No