Long-Term Follow-Up Study of Psoriasis Patients

September 18, 2008 updated by: MedImmune LLC

Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507

The purpose of this study is to evaluate the long-term safety and profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the long-term safety and lymphocyte repletion profile of psoriasis patients who have completed participation in a previous study and who received treatment with MEDI-507. Patients must have had an ALC > 30% lower than baseline (defined as baseline prior to any MEDI-507 exposure); or an absolute CD4 count of < 250 cells/uL. This study will also evaluate the development and durability of anti-MEDI-507 antibodies.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 185
        • Universitaur Ziekenhuis Gent
      • Liege, Belgium, 4020
        • CHU Centre Ville
  • Canada
      • Montreal, Canada, H2K 4L5
        • Innovaderm Research
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1V7
        • Capital District Health Authority, QE II Health Sciences Center
    • Quebec
      • Montreal, Quebec, Canada, H3H1V4
        • International Dermatology Research
  • France
      • Nantes Cedex 1, France, F-44093
        • Hotel Dieu/Clinque Dermatologique
      • Paris, France, F-75475
        • Hospital Saint-Louis Service de Dermatologie 1
      • Pessac, France, F-33600
        • Hospital Haut Leveque CHU Sud -Service de Dermatologie
  • Germany
      • Dresden, Germany, D-01307
        • Universitataskilinkum der TU Dresden
      • Dusseldorf, Germany, D-40225
        • Universitatsklinikum Hautklinik
      • Frankfurt, Germany, D-60590
        • Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt
      • Freiburg, Germany, D-79104
        • St. Urban, Dermatologie
      • Tubingen, Germany, D-72076
        • Universitatsklinikum Hautklinik
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA)
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Dermatology Research Clinic
    • Colorado
      • Denver, Colorado, United States, 80246
        • Cherry Creek Dermatology
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Atlanta Dermatology, Vein & Research Center, LLC
    • Massachusetts
      • Springfield, Massachusetts, United States, 72205
        • Future Care Studies
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University, Dermatology Clinical Trials Unit
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • VA Medical Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Kinetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient has previously completed participation

Description

Inclusion Criteria:

  • The patient has previously completed participation (i.e., completed per protocol, including any long term follow-up; or discontinued from the study due to withdrawal of consent, loss to follow-up, or other reason) in a Medimmune, Inc. study of MEDI-507 in psoriasis in which they received MEDI-507 (or placebo for patients who participated in a blinded placebo-controlled study of MEDI-507, and for whom the treatment assignment in that study has not been unblinded at the time of entry into this study)
  • The patient had an absolute lymphocyte count (ALC) > 30% lower than baseline (defined as baseline prior to any MEDI-507 exposure; or, for patients whose treatment assignments have not been unblinded at the time of entry into this study, drug exposure) at his/her final visit (excluding any long-term follow-up visits) in the most recent Medimmune, Inc. study in which the patient participated; or the patient had an absolute CD4 count of < 250 cells/uL at his/her final visit (including any protocol-specific long-term follow up) in the most recent Medimmune, Inc. study in which the patient participated.
  • Written informed consent obtained from the patient

Exclusion Criteria:

  • There are no exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

  • Study Director: Barbara White, M.D., MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 15, 2005

First Submitted That Met QC Criteria

August 15, 2005

First Posted (Estimate)

August 17, 2005

Study Record Updates

Last Update Posted (Estimate)

September 22, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI-CP085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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