Psoriatic Arthritis Research Collaborative: Biologic Sub-Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-31

Study Completion Date

2023-08-16

Brief Summary

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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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Detailed Description

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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.

Conditions

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Psoriatic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Group

This is an observational study with only one group/cohort with no intervention

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No