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

NCT01812954 | Completed DMC

• 2 other identifiers: PSO-GOE50310
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

moderate-to-severe psoriasis; cost utility analysis; cost effectiveness analysis; systemic treatment

Outcome Measures

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

  1 year

Interventions

Methotrexate DRUG

Cyclosporins DRUG

fumaric acid DRUG

Acitretin DRUG

Infliximab DRUG

etanercept DRUG

Adalimumab DRUG

Ustekinumab DRUG

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with moderate-to-severe psoriasis, who require systemic treatment to adequately control the disease

You may qualify if:

• diagnosis of moderate-to-severe psoriasis

Sponsors & Collaborators

• Jochen Schmitt.: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Psoriasis

Interventions

Methotrexate; Cyclosporins; fumaric acid; Acitretin; Infliximab; Etanercept; Adalimumab; Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized

Study Officials

• Jochen Schmitt, MD, MPH

  University Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Center for evidence-based healthcare

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 18, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 11, 2017

Record last verified: 2017-08