Psoriasis Clinical Trial

Psoriatic Arthritis Research Collaborative: Biologic Sub-Study

Summary

Psoriatic arthritis (PsA) is an inflammatory arthritis with substantial variation in clinical features. We propose a multicenter collaborative approach to better understand the phenotypes and current management of PsA in the United States.The central goal of this proposal is to obtain the data necessary to design a pragmatic trial in PsA.

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Full Description

Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that can be associated with devastating outcomes including irreversible joint damage. The management of a patient with PsA is extremely challenging due to the high degree of phenotypic heterogeneity. The ultimate goal of this proposal is to prepare pragmatic trials in PsA trials that will encompass all relevant subgroups of patients. The aims of this study specifically focus on responses to biologic therapy among patients with PsA and determining the optimal set of outcome measures for PsA trials.

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Eligibility Criteria

Inclusion Criteria:

Age 18-89
Active PsA (at least one swollen joint or enthesitis) -Meet CASPAR criteria (Table 2) (103) -Initiation of TNFi (etanercept, adalimumab, infliximab, certolizumab, golimumab) (At the time of the submission, TNFi biosimilars have been approved by the FDA but are not available on the US market. Once available, patients starting TNFi biosimilars will similarly be eligible for participation. Patients may have been on the medication in the past but must have had greater than 2 months off the medication.Patients may be taking other traditional DMARDs. A washout period is not required.)

Exclusion Criteria:

Unable to give informed consent
Out of the age range
Switching therapies for skin psoriasis in the setting of well controlled joint and enthesis symptoms.
Patients with only active PsA

Study is for people with:

Psoriasis

Estimated Enrollment:

20

Study ID:

NCT03378336

Recruitment Status:

Completed

Sponsor:

University of Pennsylvania

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There are 4 Locations for this study

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NYU School of Medicine
New York New York, 10003, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Hospital at the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Utah
Salt Lake City Utah, 84132, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Estimated Enrollment:

20

Study ID:

NCT03378336

Recruitment Status:

Completed

Sponsor:


University of Pennsylvania

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