Psoriatic Arthritis Research Collaborative: Biologic Sub-Study

Completed

• Conditions: Psoriatic Arthritis

• Registration Number: NCT03378336
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-19
• Study Start: 2017-12-31
• Primary Completion: 2023-08-16
• Study Completion: 2023-08-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Function Response to Biologic Therapy as measured by RAPID3	3 Months	Patient's perception of response to therapy as related to patient functionality. Measured by RAPID3 at baseline and 3 month visit.

Secondary Outcome Measures

Name	Time	Method
Patient Quality of Life Response to Biologic Therapy as measured by PSAID	3 Months	Patient's perception of response to therapy as related to quality of life. Measured by PSAID survey at baseline and 3 month visit.
Physician assessment of disease response to biologic therapy as measured by tender joint count.	3 Months	Physician assessment of disease activity as measured by tender joint count.
Disease Activity and Response to Biologic Therapy as measured by Patient Global Assessment	3 Months	Disease Activity and Response to Biologic Therapy as measured by Patient Global Assessment at baseline and 3 month visit.
Patient Function Response to Biologic Therapy as measured by HAQ-DI	3 Months	Patient's perception of response to therapy as related to patient functionality. Measured by HAQ-DI survey at baseline and 3 month visit.
Physician assessment of disease response to biologic therapy as measured by swollen joint count.	3 Months	Physician assessment of disease activity as measured by swollen joint count.
Disease Activity and Response to Biologic Therapy as measured by Physician Global Assessment	3 Months	Disease Activity and Response to Biologic Therapy as measured by Physician Global Assessment at baseline and 3 month visit.
Patient Quality of Life Response to Biologic Therapy as measured by PROMIS10	3 Months	Patient's perception of response to therapy as related to quality of life. Measured by PROMIS10 at baseline and 3 month visit.
Disease Activity and Response to Biologic Therapy as measured by Patient Pain Assessment	3 Months	Disease Activity and Response to Biologic Therapy as measured by Patient Pain Assessment at baseline and 3 month visit.

Trial Locations

Locations (4)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Hospital at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

NYU School of Medicine; 🇺🇸 New York, New York, United States