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

NCT ID: NCT01812954

Last Updated: 2017-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Methotrexate

Intervention Type DRUG

Cyclosporins

Intervention Type DRUG

fumaric acid

Intervention Type DRUG

Acitretin

Intervention Type DRUG

Infliximab

Intervention Type DRUG

etanercept

Intervention Type DRUG

Adalimumab

Intervention Type DRUG

Ustekinumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-diagnosis of moderate-to-severe psoriasis

Exclusion Criteria

\-
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Jochen Schmitt.

OTHER

Sponsor Role lead

Responsible Party

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Jochen Schmitt.

Director of Center for evidence-based healthcare

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jochen Schmitt, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University Dresden

Other Identifiers

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50310

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PSO-GOE

Identifier Type: -

Identifier Source: org_study_id

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