Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

This study has been terminated.
(efalizumab was withdrawn from market; full 2 years follow-up only 14 patients)
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00184366
First received: September 13, 2005
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.

Condition Intervention Phase
Plaque Psoriasis
Drug: efalizumab
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Response PASI 75 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dermatology Life Quality index (DLQI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Psoriasis disability Index (PDI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: May 2005
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: efalizumab
    efalizumab
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients of both genders, over the age of 18 years who have been suffering from moderate to severe plaque psoriasis for more than six months and who are eligible for efalizumab treatment according to current Norwegian guidelines.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184366

Locations
Norway
Dep of dermatology, St Olavs Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Chair: Morten Dalaker, univ lekt II St Olavs hospital, NTNU, Norway
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00184366     History of Changes
Other Study ID Numbers: ROCAC
Study First Received: September 13, 2005
Last Updated: January 18, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
drug therapy
efalizumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014