PsoriasisNCT01812954
Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis
An observational study of Psoriasis, run by Jochen Schmitt..
Trial summary
This study is health economic analysis of medicinal treatment options for moderate-to-severe psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for moderate-to-severe psoriasis. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Methotrexate, Cyclosporins and fumaric acid
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2014
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with moderate-to-severe psoriasis, who require systemic treatment to adequately control the disease
Who may be able to join
- -diagnosis of moderate-to-severe psoriasis
Who cannot join
- -
About this study
This study is health economic analysis of medicinal treatment options for moderate-to-severe psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various different sources, including summary of product characteristics (SPCs) and the German S3 guideline on psoriasis care, health care utilization data and official statistics.
The study aims to investigate the comparative cost-effectiveness of biologic and conventional systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as well as indirect cost will be considered.
- Conditions
- Psoriasis
- Being tested
- Methotrexate, Cyclosporins, fumaric acid, Acitretin, Infliximab
- Keywords
- moderate-to-severe psoriasis, cost utility analysis, cost effectiveness analysis, systemic treatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
CyclosporinsDrug
fumaric acidDrug
AcitretinDrug
InfliximabDrug
etanerceptDrug
AdalimumabDrug
UstekinumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost per quality-adjusted life year (QALY) gained through treatment with each individual agent compared to supportive care as well as compared to placebo
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJun 2014
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jochen Schmitt.
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Jochen Schmitt., Technische Universität Dresden
- Investigators
- Jochen Schmitt, MD, MPH, Principal investigator, University Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812954
- Sponsor's protocol ID
- PSO-GOE
- Other IDs
- 50310
- Status last verified
- Aug 2017
- First submitted
- 14 Mar 2013
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis
- ClinicalTrials.gov ID
- NCT01812954
- Acronym / sponsor ID
- PSO-GOE
- Conditions
- Psoriasis
- Keywords
- moderate-to-severe psoriasis, cost utility analysis, cost effectiveness analysis, systemic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Jochen Schmitt.University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Mar 2013 (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 study is health economic analysis of medicinal treatment options for moderate-to-severe psoriasis vulgaris from the societal perspective. Efficacy data and other clinical outcomes will be derived from an up-to-date meta-analysis of randomized clinical trials (RCTs) for moderate-to-severe psoriasis. Direct and indirect costs will be extracted from various different sources, including summary of product characteristics (SPCs) and the German S3 guideline on psoriasis care, health care utilization data and official statistics.
The study aims to investigate the comparative cost-effectiveness of biologic and conventional systemic treatments currently (as of June 1st, 2012) approved for moderate-to-severe plaque-type psoriasis in Germany. Effectiveness will be measured by means of the pooled (Psoriasis Area and Severity Index) PASI-75 response rates as reported in RCTs Direct cost as well as indirect cost will be considered.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with moderate-to-severe psoriasis, who require systemic treatment to adequately control the disease
Key inclusion criteria (1 listed)
- -diagnosis of moderate-to-severe psoriasis
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Methotrexate | Drug | – |
| Cyclosporins | Drug | – |
| fumaric acid | Drug | – |
| Acitretin | Drug | – |
| Infliximab | Drug | – |
| etanercept | Drug | – |
| Adalimumab | Drug | – |
| Ustekinumab | Drug | – |
Primary outcome
Cost per quality-adjusted life year (QALY) gained through treatment with each individual agent compared to supportive care as well as compared to placebo
Time frame: 1 year
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 11 Aug 2017.
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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.
Jochen Schmitt, MD, MPH principal investigator
University Dresden
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Jochen Schmitt..
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 1 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Cost per quality-adjusted life year (QALY) gained through treatment with each individual agent compared to supportive care as well as compared to placebo (time frame: 1 year). 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 11 Aug 2017.