Long-Term Follow-Up Study of Psoriasis Patients - Full Text View

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00131066

Purpose

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.

Condition	Intervention
Psoriasis	Other: Follow up from previous treatment with MEDI-507

MedlinePlus related topics: Psoriasis

Drug Information available for: Siplizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507

Further study details as provided by MedImmune LLC:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	200
Study Start Date:	August 2002
Study Completion Date:	December 2007
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Intervention Details:

There will be no investigational drugs administered under this protocol.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patient has previously completed participation

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131066

Locations

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

Sponsors and Collaborators

MedImmune LLC

Investigators

Study Director:

Barbara White, M.D.

MedImmune LLC

More Information

Responsible Party:	MedImmune Inc. ( Barbara White )
Study ID Numbers:	MI-CP085
Study First Received:	August 15, 2005
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00131066
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedImmune LLC:

Previously enrolled on a MEDI-507 for psoriasis

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 16, 2009