Clinical trial NCT00131066: Long-Term Follow-Up Study of Psoriasis Patients
Official title: Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Previously enrolled on a MEDI-507 for psoriasis
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient has previously completed participation

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Dermatology Research Clinic
state: Arkansas
city: Denver
country: United States
facility: Cherry Creek Dermatology
state: Colorado
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, LLC
state: Georgia
city: Springfield
country: United States
facility: Future Care Studies
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University, Dermatology Clinical Trials Unit
state: Missouri
city: Nashville
country: United States
facility: VA Medical Center
state: Tennessee
city: Tacoma
country: United States
facility: Northwest Kinetics
state: Washington
city: Gent
country: Belgium
facility: Universitaur Ziekenhuis Gent
city: Liege
country: Belgium
facility: CHU Centre Ville
city: Halifax
country: Canada
facility: Capital District Health Authority, QE II Health Sciences Center
state: Nova Scotia
city: Montreal
country: Canada
facility: International Dermatology Research
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Research
city: Nantes Cedex 1
country: France
facility: Hotel Dieu/Clinque Dermatologique
city: Paris
country: France
facility: Hospital Saint-Louis Service de Dermatologie 1
city: Pessac
country: France
facility: Hospital Haut Leveque CHU Sud -Service de Dermatologie
city: Dresden
country: Germany
facility: Universitataskilinkum der TU Dresden
city: Dusseldorf
country: Germany
facility: Universitatsklinikum Hautklinik
city: Frankfurt
country: Germany
facility: Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt
city: Freiburg
country: Germany
facility: St. Urban, Dermatologie
city: Tubingen
country: Germany
facility: Universitatsklinikum Hautklinik
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA)
Study officials:
affiliation: MedImmune LLC
name: Barbara White, M.D.
role: STUDY_DIRECTOR
References: