Clinical trial NCT00303186: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic, Psoriasis
Keywords: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-03-15
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


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.

Primary outcomes:
measure: Mean Cost Per Participant Per Month at Month 12
timeFrame: Month 12
measure: Mean Cost Per Participant Per Month at Month 60
timeFrame: Month 60
measure: Incremental Cost-effectiveness Ratio (ICER)
timeFrame: Baseline up to Month 60
Secondary outcomes:
measure: Number of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 Response
timeFrame: Month 6, Month 12, Month 18, Month 24, Month 60
measure: Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
timeFrame: Month 6, Month 12, Month 18, Month 24, Month 60
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Bath Ankylosing Spondylitis Radiology Index (BASRI)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Modified Schober's Test
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Chest Expansion Measurement
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Occiput-to-wall Distance
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Maastricht Ankylosing Spondylitis Enthesis Score (MASES)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Number of Swollen and Tender Joints
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
timeFrame: Month 6, Month 12, Month 18, Month 24, Month 60
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
timeFrame: Month 6, Month 12, Month 18, Month 24, Month 60
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
timeFrame: Month 6, Month 12, Month 18, Month 24, Month 60
measure: Radiographic Score Based on Wassenberg
timeFrame: Baseline, Month 12, Month 24, Month 60
measure: Patient Global Assessment (PtGA) of Disease Activity Score
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Physician Global Assessment (PGA) of Disease Activity
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Visual Analogue Scale for Pain (VAS-pain)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: C-reactive Protein (CRP)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Duration of Morning Stiffness
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
measure: 36-Item Short-Form Health Survey (SF-36)
timeFrame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 60
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Pfizer Investigational Site
state: Campania
city: Prato
country: Italy
facility: Pfizer Investigational Site
state: FI - Italy
city: Benevento
country: Italy
facility: Pfizer Investigational Site
city: Cagliari
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Potenza
country: Italy
facility: Pfizer Investigational Site
city: Reggio Emilia
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.