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

NCT00303186

Last updated date
Study Location
Pfizer Investigational Site
Napoli, Campania, 80131, Italy
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title Study Evaluating the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy
Official Title An Observational Study to Evaluate the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy
Brief Summary 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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with PsA who are failure to the conventional treatments according to the local recommendations, will be enrolled in the study through tertiary referrals centers (HRCs i.e., Hospital Rheumatolgic Centers).
Condition Arthritis, Psoriatic, Psoriasis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 5, 2012)
107
Original Enrollment
 (submitted: March 14, 2006)
200
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT00303186
Other Study ID Numbers 0881A-101750
B1801109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2012