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Trial record 28 of 31 for:    ACITRETIN

Economic Evaluation of Systemic Treatments for Moderate-to-severe Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01812954
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : August 11, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jochen Schmitt., Technische Universität Dresden

Brief 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. 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.

Condition or disease Intervention/treatment
Psoriasis Drug: Methotrexate Drug: Cyclosporins Drug: fumaric acid Drug: Acitretin Drug: Infliximab Drug: etanercept Drug: Adalimumab Drug: Ustekinumab

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Other
Time Perspective: Retrospective
Study Start Date : March 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with moderate-to-severe psoriasis, who require systemic treatment to adequately control the disease

Inclusion Criteria:

-diagnosis of moderate-to-severe psoriasis

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01812954

Sponsors and Collaborators
Jochen Schmitt.
Merck Sharp & Dohme Corp.
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Principal Investigator: Jochen Schmitt, MD, MPH University Dresden

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Responsible Party: Jochen Schmitt., Director of Center for evidence-based healthcare, Technische Universität Dresden Identifier: NCT01812954     History of Changes
Other Study ID Numbers: PSO-GOE
50310 ( Other Grant/Funding Number: MSD Sharp&Dohme GmbH )
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Keywords provided by Jochen Schmitt., Technische Universität Dresden:
moderate-to-severe psoriasis
cost utility analysis
cost effectiveness analysis
systemic treatment
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents