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Study Evaluating the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy

NCT ID: NCT00303186

Last Updated: 2012-07-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to conduct an economic analysis on the cost of conventional therapy as compared to biologic therapy and the direct/indirect costs of disease management in patients with refractory psoriatic arthritis (PsA). Primary outcomes are to qualify the economic burden of refractory PsA care. The secondary outcomes are to assess efficacy, safety, and cost effectiveness of different therapies.

Detailed Description

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Conditions

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Arthritis, Psoriatic, Psoriasis

Keywords

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Eighteen years of age or older
* Inflammatory arthropathy associated with psoriasis meet the ACR criteria for PsA
* Patients with diagnosis of active and progressive PsA who have failure with conventional treatments

Exclusion Criteria

* Significant concurrent medical diseases including cancer or a history of cancer, uncontrolled congestive heart failure, myocardial infarctions within 12 months or other clinically significant cardiovascular diseases, immunodeficiency syndromes or concomitant infectious diseases.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Cagliari, Cagliari, Italy

Site Status

Pfizer Investigational Site

Napoli, Campania, Italy

Site Status

Pfizer Investigational Site

Prato, FI - Italy, Italy

Site Status

Pfizer Investigational Site

Florence, Italy, Italy

Site Status

Pfizer Investigational Site

Padua, Padova, Italy

Site Status

Pfizer Investigational Site

Potenza, Potenza, Italy

Site Status

Pfizer Investigational Site

Reggio Emilia, Reggio Emilia, Italy

Site Status

Pfizer Investigational Site

Roma, Roma, Italy

Site Status

Pfizer Investigational Site

Benevento, , Italy

Site Status

Countries

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Italy

References

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Olivieri I, Cortesi PA, de Portu S, Salvarani C, Cauli A, Lubrano E, Spadaro A, Cantini F, Ciampichini R, Cutro MS, Mathieu A, Matucci-Cerinic M, Punzi L, Scarpa R, Mantovani LG; PACE Working Group. Long-term costs and outcomes in psoriatic arthritis patients not responding to conventional therapy treated with tumour necrosis factor inhibitors: the extension of the Psoriatic Arthritis Cost Evaluation (PACE) study. Clin Exp Rheumatol. 2016 Jan-Feb;34(1):68-75. Epub 2015 Dec 3.

Reference Type DERIVED
PMID: 26633622 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A-101750&StudyName=Study%20Evaluating%20the%20Cost%20of%20the%20Treatments%20of%20the%20Refractory%20Psoriatic%20Arthritis%20to%20the%20Conventional%20Therapy

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Other Identifiers

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B1801109

Identifier Type: -

Identifier Source: secondary_id

0881A-101750

Identifier Type: -

Identifier Source: org_study_id