Study Evaluating the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy
NCT00303186
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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 | 107 | |||
| Original Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2012 | |||