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Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00184366
Recruitment Status : Terminated (efalizumab was withdrawn from market; full 2 years follow-up only 14 patients)
First Posted : September 16, 2005
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 16, 2005
Last Update Posted Date January 19, 2012
Study Start Date May 2005
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 18, 2012)
Response PASI 75 [ Time Frame: 2 years ]
Original Primary Outcome Measures
 (submitted: September 13, 2005)
Response PASI 75
Change History
Current Secondary Outcome Measures
 (submitted: January 18, 2012)
  • Dermatology Life Quality index (DLQI) [ Time Frame: 2 years ]
  • Psoriasis disability Index (PDI) [ Time Frame: 2 years ]
Original Secondary Outcome Measures
 (submitted: September 13, 2005)
  • Dermatology Life Quality index (DLQI)
  • Psoriasis disability Index (PDI)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis
Official Title Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab
Brief 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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Plaque Psoriasis
Intervention Drug: efalizumab
efalizumab
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 18, 2012)
96
Original Enrollment
 (submitted: September 13, 2005)
148
Actual Study Completion Date July 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT00184366
Other Study ID Numbers ROCAC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor Norwegian University of Science and Technology
Collaborators Not Provided
Investigators
Study Chair: Morten Dalaker, univ lekt II St Olavs hospital, NTNU, Norway
PRS Account Norwegian University of Science and Technology
Verification Date January 2012