Psoriasis Clinical Trial
Long-Term Follow-Up Study of Psoriasis Patients
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.
Full 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 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.
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There are 20 Locations for this study
Little Rock Arkansas, 72205, United States
Denver Colorado, 80246, United States
Alpharetta Georgia, 30005, United States
Springfield Massachusetts, 72205, United States
St. Louis Missouri, 63110, United States
Nashville Tennessee, 37212, United States
Tacoma Washington, 98405, United States
Gent , 185, Belgium
Liege , 4020, Belgium
Halifax Nova Scotia, B3H1V, Canada
Montreal Quebec, H3H1V, Canada
Montreal , H2K 4, Canada
Nantes Cedex 1 , F-440, France
Paris , F-754, France
Pessac , F-336, France
Dresden , D-013, Germany
Dusseldorf , D-402, Germany
Frankfurt , D-605, Germany
Freiburg , D-791, Germany
Tubingen , D-720, Germany
Amsterdam , 1105, Netherlands
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