Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

NCT ID: NCT00184366

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Plaque Psoriasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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efalizumab

efalizumab

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morten Dalaker, univ lekt II

Role: STUDY_CHAIR

St Olavs hospital, NTNU, Norway

Locations

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Dep of dermatology, St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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ROCAC

Identifier Type: -

Identifier Source: org_study_id

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