PsoriasisNCT00894777
Study Evaluating Management of Patients With Moderate and Severe Psoriasis
An observational study of Psoriasis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Spain.
Trial summary
This is an observational, naturalistic, multicenter, retrospective study to describe the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs in usual clinical practice in Spain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Clinical record review
- How many people
- 469 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2009to Nov 2009
- 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 with moderate and severe psoriasis under treatment with topical and/or systemic drugs in usual clinical practice
Main Inclusion Criteria:
·Over 18 years of age.·Diagnosed with moderate or severe psoriasis.·Initiated treatment with topical and/or systemic treatment between two and five years before enrollment in the study. ·Has a clinical record at the dermatologist office.
Main Exclusion Criteria:
·Currently participating in a clinical study. ·Clinical record lacks minimum data required for observational analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Patients With Moderate and Severe Psoriasis Under Treatment With Topical and/or Systemic Drugs
This is an observational, naturalistic, multicenter, retrospective study to describe the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs in usual clinical practice in Spain.
- Conditions
- Psoriasis
- Being tested
- Clinical record review
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical record reviewOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs Receives: Other: Clinical record review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs including sequence, doses and duration of treatment.
Measured: 4 months
Secondary outcomes (1)
Comparison of therapeutic management depending on patients' disease severity, using absolute and relative frequencies for qualitative variables and centralization and dispersion measures (mean, SD, median, minimum, maximum..) for quantitative variables.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionNov 2009
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 only
- Time perspective
- Retrospective
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894777
- Sponsor's protocol ID
- 0881A6-4577
- Status last verified
- Nov 2010
- First submitted
- 6 May 2009
- Last updated
- 22 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With Moderate and Severe Psoriasis Under Treatment With Topical and/or Systemic Drugs
- ClinicalTrials.gov ID
- NCT00894777
- Acronym / sponsor ID
- 0881A6-4577
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 May 2009 (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.
This is an observational, naturalistic, multicenter, retrospective study to describe the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs in usual clinical practice in Spain.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Clinical record reviewPatients with moderate and severe psoriasis under treatment with topical and/or systemic drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs in usual clinical practice
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 |
|---|---|---|
| Clinical record review | Other | 1 |
Primary outcome
Descriptive analysis of the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs including sequence, doses and duration of treatment.
Time frame: 4 months
1 secondary outcome
Comparison of therapeutic management depending on patients' disease severity, using absolute and relative frequencies for qualitative variables and centralization and dispersion measures (mean, SD, median, minimum, maximum..) for quantitative variables.
Time frame: 4 months
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 Nov 2010.
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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.
Pfizer CT.gov Call Center study director
Wyeth is now a wholly owned subsidiary of Pfizer
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 Psoriasis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Nov 2010. 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 Spain. 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.
What does the primary outcome measure?
Descriptive analysis of the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs including sequence, doses and duration of treatment. (time frame: 4 months). 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 22 Nov 2010.