Psoriatic Arthritis Research Collaborative: Biologic Sub-Study

Psoriatic Arthritis Clinical Trial

— PARC-B  

Official title:

Psoriatic Arthritis Research Collaborative: Biologic Sub-Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378336
• Other study ID #: 828357
• Status: Completed
• Start date: December 31, 2017
• Est. completion date: August 16, 2023

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	NYU School of Medicine	New York	New York
United States	Hospital at the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	NYU Langone Health, The Cleveland Clinic, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Function Response to Biologic Therapy as measured by RAPID3	Patient's perception of response to therapy as related to patient functionality. Measured by RAPID3 at baseline and 3 month visit.	3 Months
Secondary	Patient Function Response to Biologic Therapy as measured by HAQ-DI	Patient's perception of response to therapy as related to patient functionality. Measured by HAQ-DI survey at baseline and 3 month visit.	3 Months
Secondary	Patient Quality of Life Response to Biologic Therapy as measured by PROMIS10	Patient's perception of response to therapy as related to quality of life. Measured by PROMIS10 at baseline and 3 month visit.	3 Months
Secondary	Patient Quality of Life Response to Biologic Therapy as measured by PSAID	Patient's perception of response to therapy as related to quality of life. Measured by PSAID survey at baseline and 3 month visit.	3 Months
Secondary	Physician assessment of disease response to biologic therapy as measured by swollen joint count.	Physician assessment of disease activity as measured by swollen joint count.	3 Months
Secondary	Physician assessment of disease response to biologic therapy as measured by tender joint count.	Physician assessment of disease activity as measured by tender joint count.	3 Months
Secondary	Disease Activity and Response to Biologic Therapy as measured by Patient Pain Assessment	Disease Activity and Response to Biologic Therapy as measured by Patient Pain Assessment at baseline and 3 month visit.	3 Months
Secondary	Disease Activity and Response to Biologic Therapy as measured by Physician Global Assessment	Disease Activity and Response to Biologic Therapy as measured by Physician Global Assessment at baseline and 3 month visit.	3 Months
Secondary	Disease Activity and Response to Biologic Therapy as measured by Patient Global Assessment	Disease Activity and Response to Biologic Therapy as measured by Patient Global Assessment at baseline and 3 month visit.	3 Months