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OpenTrials
Completed

NCT Number: NCT01812954

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-diagnosis of moderate-to-severe psoriasis

Exclusion criteria

-

Treatment and study plan

methotrexate

Drug

cyclosporins

Drug

Fumaric acid

Drug

acitretin

Drug

Infliximab

Drug

etanercept

Drug

Adalimumab

Drug

Ustekinumab

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jochen Schmitt.

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 18, 2013
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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