Plaque PsoriasisNCT00184366
Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis
An observational study of Plaque Psoriasis, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The main objectives of the project are: To classify patients suffering from plaque psoriasis responding on a given treatment (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI) To characterize patients suffering from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- efalizumab
- How many people
- 96 participants
- Where
- 1 siteNorway
- Study dates
- May 2005to Jul 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients of both genders, over the age of 18 years who have been suffering from moderate to severe plaque psoriasis for more than six months and who are eligible for efalizumab treatment according to current Norwegian guidelines.
Who may be able to join
- moderate to severe plaque psoriasis for more than six months
- eligible for efalizumab treatment according to current Norwegian guidelines
Who cannot join
- Pregnant or breast-feeding patients
- Patients with a history of uncontrolled bacterial, viral, fungal or atypical mycobacterial infection.
- Patients suffering from HIV, Hepatitis B or C, active tuberculosis, hepatic cirrhosis and hospital admission for cardiac disease, stroke or pulmonary disease within last year.
- Patients with history of cancer in the preceding 5 years, including lymphoproliferative disorders. patients with history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
- Patients with impaired renal or hepatic function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab
The main objectives of the project are:
- To classify patients suffering from plaque psoriasis responding on a given treatment (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI)
- To characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administrated efalizumab.
Read the detailed description
This is an investigator initiated,prospective, longitudinal, observation study. Before starting treatment with efalizumab we will record factors such as demographic data, type of psoriasis, previous treatment, other diseases etc.
We will follow the patients and classify them as responders and non-responders. We hope to find 4-5 factors which we can use later to predict response of this drug.
- Conditions
- Plaque Psoriasis
- Being tested
- efalizumab
- Keywords
- drug therapy, efalizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efalizumabDrug
efalizumab
What is being measured
The primary outcome is the main question the study is designed to answer.
Response PASI 75
Measured: 2 years
Secondary outcomes (2)
Dermatology Life Quality index (DLQI)
Measured: 2 years
Psoriasis disability Index (PDI)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionMay 2008
- Study completionJul 2008
Why it stopped: efalizumab was withdrawn from market; full 2 years follow-up only 14 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morten Dalaker, univ lekt II, Study chair, St Olavs hospital, NTNU, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184366
- Sponsor's protocol ID
- ROCAC
- Status last verified
- Jan 2012
- First submitted
- 13 Sep 2005
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab
- ClinicalTrials.gov ID
- NCT00184366
- Acronym / sponsor ID
- ROCAC
- Conditions
- Plaque Psoriasis
- Keywords
- drug therapy, efalizumab
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: efalizumab was withdrawn from market; full 2 years follow-up only 14 patients
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Sep 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 main objectives of the project are:
- To classify patients suffering from plaque psoriasis responding on a given treatment (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI)
- To characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administrated efalizumab.
Detailed description
This is an investigator initiated,prospective, longitudinal, observation study. Before starting treatment with efalizumab we will record factors such as demographic data, type of psoriasis, previous treatment, other diseases etc.
We will follow the patients and classify them as responders and non-responders. We hope to find 4-5 factors which we can use later to predict response of this drug.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of both genders, over the age of 18 years who have been suffering from moderate to severe plaque psoriasis for more than six months and who are eligible for efalizumab treatment according to current Norwegian guidelines.
Key inclusion criteria (2 listed)
- moderate to severe plaque psoriasis for more than six months
- eligible for efalizumab treatment according to current Norwegian guidelines
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding patients
- Patients with a history of uncontrolled bacterial, viral, fungal or atypical mycobacterial infection.
- Patients suffering from HIV, Hepatitis B or C, active tuberculosis, hepatic cirrhosis and hospital admission for cardiac disease, stroke or pulmonary disease within last year.
- Patients with history of cancer in the preceding 5 years, including lymphoproliferative disorders. patients with history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
- Patients with impaired renal or hepatic function.
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 |
|---|---|---|
| efalizumabefalizumab | Drug | – |
Primary outcome
Response PASI 75
Time frame: 2 years
2 secondary outcomes
Dermatology Life Quality index (DLQI)
Time frame: 2 years
Psoriasis disability Index (PDI)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: efalizumab was withdrawn from market; full 2 years follow-up only 14 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
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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.
Morten Dalaker, univ lekt II study chair
St Olavs hospital, NTNU, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 was stopped early (reason given: efalizumab was withdrawn from market; full 2 years follow-up only 14 patients). Results are not available in the source record.
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.
What does the primary outcome measure?
Response PASI 75 (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 19 Jan 2012.