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Long-Term Follow-Up Study of Psoriasis Patients

NCT ID: NCT00131066

Last Updated: 2008-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Psoriasis

Keywords

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Previously enrolled on a MEDI-507 for psoriasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Follow up from previous treatment with MEDI-507

There will be no investigational drugs administered under this protocol.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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MedImmune Inc.

Principal Investigators

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Barbara White, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Dermatology Research Clinic

Little Rock, Arkansas, United States

Site Status

Cherry Creek Dermatology

Denver, Colorado, United States

Site Status

Atlanta Dermatology, Vein & Research Center, LLC

Alpharetta, Georgia, United States

Site Status

Future Care Studies

Springfield, Massachusetts, United States

Site Status

Washington University, Dermatology Clinical Trials Unit

St Louis, Missouri, United States

Site Status

VA Medical Center

Nashville, Tennessee, United States

Site Status

Northwest Kinetics

Tacoma, Washington, United States

Site Status

Universitaur Ziekenhuis Gent

Ghent, , Belgium

Site Status

CHU Centre Ville

Liège, , Belgium

Site Status

Capital District Health Authority, QE II Health Sciences Center

Halifax, Nova Scotia, Canada

Site Status

International Dermatology Research

Montreal, Quebec, Canada

Site Status

Innovaderm Research

Montreal, , Canada

Site Status

Hotel Dieu/Clinque Dermatologique

Nantes, , France

Site Status

Hospital Saint-Louis Service de Dermatologie 1

Paris, , France

Site Status

Hospital Haut Leveque CHU Sud -Service de Dermatologie

Pessac, , France

Site Status

Universitataskilinkum der TU Dresden

Dresden, , Germany

Site Status

Universitatsklinikum Hautklinik

Düsseldorf, , Germany

Site Status

Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt

Frankfurt, , Germany

Site Status

St. Urban, Dermatologie

Freiburg im Breisgau, , Germany

Site Status

Universitatsklinikum Hautklinik

Tübingen, , Germany

Site Status

Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA)

Amsterdam, , Netherlands

Site Status

Countries

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United States Belgium Canada France Germany Netherlands

Other Identifiers

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MI-CP085

Identifier Type: -

Identifier Source: org_study_id