PsoriasisNCT00131066
Long-Term Follow-Up Study of Psoriasis Patients
An observational study of Psoriasis, run by MedImmune LLC at 21 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Follow up from previous treatment with MEDI-507
- How many people
- 200 participants
- Where
- 21 sitesin 6 countries
- Study dates
- Aug 2002to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient has previously completed participation
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States7 sites
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30005
Cherry Creek Dermatology
Denver, Colorado, 80246
Dermatology Research Clinic
Little Rock, Arkansas, 72205
VA Medical Center
Nashville, Tennessee, 37212
Future Care Studies
Springfield, Massachusetts, 72205
Washington University, Dermatology Clinical Trials Unit
St Louis, Missouri, 63110
Northwest Kinetics
Tacoma, Washington, 98405
Germany5 sites
Universitataskilinkum der TU Dresden
Dresden, D-01307
Universitatsklinikum Hautklinik
Düsseldorf, D-40225
Klinikum de Johann - Wolfgang Goethe Universitate Frankfurt
Frankfurt, D-60590
St. Urban, Dermatologie
Freiburg im Breisgau, D-79104
Universitatsklinikum Hautklinik
Tübingen, D-72076
Canada3 sites
Capital District Health Authority, QE II Health Sciences Center
Halifax, Nova Scotia, B3H1V7
International Dermatology Research
Montreal, Quebec, H3H1V4
Innovaderm Research
Montreal, H2K 4L5
France3 sites
Hotel Dieu/Clinque Dermatologique
Nantes, F-44093
Hospital Saint-Louis Service de Dermatologie 1
Paris, F-75475
Hospital Haut Leveque CHU Sud -Service de Dermatologie
Pessac, F-33600
Belgium2 sites
Universitaur Ziekenhuis Gent
Ghent, 185
CHU Centre Ville
Liège, 4020
Netherlands1 site
Academisch Medisch Centrum/Universiteit van Amsterdam (AMC/UvA)
Amsterdam, 1105
About this study
Official title: Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Follow up from previous treatment with MEDI-507
- Keywords
- Previously enrolled on a MEDI-507 for psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up from previous treatment with MEDI-507Other
There will be no investigational drugs administered under this protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startAug 2002
- Primary completionOct 2003
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Barbara White, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131066
- Sponsor's protocol ID
- MI-CP085
- Status last verified
- Sep 2008
- First submitted
- 15 Aug 2005
- Last updated
- 22 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Safety Follow-Up Study of Psoriasis Patients Who Have Received MEDI-507
- ClinicalTrials.gov ID
- NCT00131066
- Acronym / sponsor ID
- MI-CP085
- Conditions
- Psoriasis
- Keywords
- Previously enrolled on a MEDI-507 for psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Oct 2003 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient has previously completed participation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow up from previous treatment with MEDI-507There will be no investigational drugs administered under this protocol. | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara White, M.D. study director
MedImmune LLC
21 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by MedImmune LLC at 21 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Canada, France, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2008.