Long-Term Follow-Up Study of Psoriasis Patients
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00131066
First received: August 15, 2005
Last updated: September 18, 2008
Last verified: September 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Psoriasis |
Other: Follow up from previous treatment with MEDI-507 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507 |
Resource links provided by NLM:
Further study details as provided by MedImmune LLC:
| Enrollment: | 200 |
| Study Start Date: | August 2002 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: Follow up from previous treatment with MEDI-507
There will be no investigational drugs administered under this protocol.
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patient has previously completed participation
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131066
Locations
| United States, Arkansas | |
| Dermatology Research Clinic | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, Colorado | |
| Cherry Creek Dermatology | |
| Denver, Colorado, United States, 80246 | |
| United States, Georgia | |
| Atlanta Dermatology, Vein & Research Center, LLC | |
| Alpharetta, Georgia, United States, 30005 | |
| United States, Massachusetts | |
| Future Care Studies | |
| Springfield, Massachusetts, United States, 72205 | |
| United States, Missouri | |
| Washington University, Dermatology Clinical Trials Unit | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Tennessee | |
| VA Medical Center | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Washington | |
| Northwest Kinetics | |
| Tacoma, Washington, United States, 98405 | |
| Belgium | |
| Universitaur Ziekenhuis Gent | |
| Gent, Belgium, 185 | |
| CHU Centre Ville | |
| Liege, Belgium, 4020 | |
| Canada, Nova Scotia | |
| Capital District Health Authority, QE II Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H1V7 | |
| Canada, Quebec | |
| International Dermatology Research | |
| Montreal, Quebec, Canada, H3H1V4 | |
| Canada | |
| Innovaderm Research | |
| Montreal, Canada, H2K 4L5 | |
| France | |
| Hotel Dieu/Clinque Dermatologique | |
| Nantes Cedex 1, France, F-44093 | |
| Hospital Saint-Louis Service de Dermatologie 1 | |
| Paris, France, F-75475 | |
| Hospital Haut Leveque CHU Sud -Service de Dermatologie | |
| Pessac, France, F-33600 | |
| Germany | |
| Universitataskilinkum der TU Dresden | |
| Dresden, Germany, D-01307 | |
| Universitatsklinikum Hautklinik | |
| Dusseldorf, Germany, D-40225 | |
| Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt | |
| Frankfurt, Germany, D-60590 | |
| St. Urban, Dermatologie | |
| Freiburg, Germany, D-79104 | |
| Universitatsklinikum Hautklinik | |
| Tubingen, Germany, D-72076 | |
| Netherlands | |
| Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA) | |
| Amsterdam, Netherlands, 1105 | |
Sponsors and Collaborators
MedImmune LLC
Investigators
| Study Director: | Barbara White, M.D. | MedImmune LLC |
More Information
No publications provided
| Responsible Party: | Barbara White, MedImmune Inc. |
| ClinicalTrials.gov Identifier: | NCT00131066 History of Changes |
| Other Study ID Numbers: | MI-CP085 |
| Study First Received: | August 15, 2005 |
| Last Updated: | September 18, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by MedImmune LLC:
|
Previously enrolled on a MEDI-507 for psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013