Status:
COMPLETED
Long-Term Follow-Up Study of Psoriasis Patients
Lead Sponsor:
MedImmune LLC
Conditions:
Psoriasis
Eligibility:
All Genders
18-65 years
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. Pati...
Eligibility Criteria
Inclusion
- 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
- There are no exclusion criteria.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00131066
Start Date
August 1 2002
End Date
December 1 2007
Last Update
September 22 2008
Active Locations (21)
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1
Dermatology Research Clinic
Little Rock, Arkansas, United States, 72205
2
Cherry Creek Dermatology
Denver, Colorado, United States, 80246
3
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States, 30005
4
Future Care Studies
Springfield, Massachusetts, United States, 72205