Long-Term Follow-Up Study of Psoriasis Patients

Completed

• Conditions: Psoriasis

• Registration Number: NCT00131066
• Lead Sponsor: MedImmune LLC

Brief Summary

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.

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 Timeline

• Study Start: 2002-08
• Primary Completion: 2003-10
• Study First Submitted: 2005-08-15
• Study First Submitted QC: 2005-08-15
• Study First Posted: 2005-08-17
• Study Completion: 2007-12
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-18
• Last Update Posted: 2008-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (20)

Cherry Creek Dermatology; 🇺🇸 Denver, Colorado, United States

Future Care Studies; 🇺🇸 Springfield, Massachusetts, United States

Universitaur Ziekenhuis Gent; 🇧🇪 Gent, Belgium

St. Urban, Dermatologie; 🇩🇪 Freiburg, Germany

Atlanta Dermatology, Vein & Research Center, LLC; 🇺🇸 Alpharetta, Georgia, United States

Washington University, Dermatology Clinical Trials Unit; 🇺🇸 St. Louis, Missouri, United States

Northwest Kinetics; 🇺🇸 Tacoma, Washington, United States

CHU Centre Ville; 🇧🇪 Liege, Belgium

VA Medical Center; 🇺🇸 Nashville, Tennessee, United States

Innovaderm Research; 🇨🇦 Montreal, Canada

Hotel Dieu/Clinque Dermatologique; 🇫🇷 Nantes Cedex 1, France

Hospital Saint-Louis Service de Dermatologie 1; 🇫🇷 Paris, France

Hospital Haut Leveque CHU Sud -Service de Dermatologie; 🇫🇷 Pessac, France

Universitataskilinkum der TU Dresden; 🇩🇪 Dresden, Germany

Universitatsklinikum Hautklinik; 🇩🇪 Tubingen, Germany

Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA); 🇳🇱 Amsterdam, Netherlands

Capital District Health Authority, QE II Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada

Dermatology Research Clinic; 🇺🇸 Little Rock, Arkansas, United States

International Dermatology Research; 🇨🇦 Montreal, Quebec, Canada

Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt; 🇩🇪 Frankfurt, Germany