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

This study is ongoing, but not recruiting participants.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00303186

Purpose

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.

Condition
Arthritis, Psoriatic, Psoriasis

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	An Observational Study to Evaluate the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy

Further study details as provided by Wyeth:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	156
Study Start Date:	February 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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 -).

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303186

Locations

Italy

Potenza, Italy, 85100

Reggio E., Italy, 42100

Firenze, Italy, 50138

Prato, Italy, 59100

Napoli, Italy, 80131

Roma, Italy, 00161

Cagliari, Italy, 09042

Benevento, Italy, 82037

Padova, Italy, 35128

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Italy, decresg@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A-101750
Study First Received:	March 14, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00303186
Health Authority:	Italy: Ministry of Health

Keywords provided by Wyeth:

Rheumatoid Arthritis

Study placed in the following topic categories:

Spinal Diseases
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Spondylarthropathy
Arthritis, Rheumatoid
Bone Diseases

Musculoskeletal Diseases
Psoriasis
Arthritis
Spondylarthritis
Skin Diseases, Papulosquamous
Spondylarthropathies

ClinicalTrials.gov processed this record on January 16, 2009