Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507

MedImmune LLC20 sites in 6 countries200 target enrollmentAugust 2002

ConditionsPsoriasis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Psoriasis
Sponsor: MedImmune LLC
Enrollment: 200
Locations: 20
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2002

End Date

December 2007

Last Updated

17 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MedImmune LLC

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