Long-Term Follow-Up Study of Psoriasis Patients

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131066
• Other study ID #: MI-CP085
• Status: Completed
• Phase: N/A
• First received: August 15, 2005
• Last updated: September 18, 2008
• Start date: August 2002
• Est. completion date: December 2007

Study information

• Verified date: September 2008
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2007
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• Follow up from previous treatment with MEDI-507
There will be no investigational drugs administered under this protocol.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Netherlands,