Long-Term Follow-Up Study of Psoriasis Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00131066

Enrollment

200

Registered

2005-08-17

Start date

2002-08-31

Completion date

2007-12-31

Last updated

2008-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Previously enrolled on a MEDI-507 for psoriasis

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.

Interventions

OTHERFollow up from previous treatment with MEDI-507

There will be no investigational drugs administered under this protocol.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026