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Sponsored by: |
MedImmune LLC |
Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00131066 |
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 |
ChemIDplus related topics: | Siplizumab |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507 |
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) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patient has previously completed participation
Inclusion Criteria:
Exclusion Criteria:
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 |
MedImmune LLC |
Study Director: | Barbara White, M.D. | MedImmune LLC |
Responsible Party: | MedImmune Inc. ( Barbara White ) |
Study ID Numbers: | MI-CP085 |
First Received: | August 15, 2005 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00131066 |
Health Authority: | United States: Food and Drug Administration |
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