Psoriatic Arthritis Research Collaborative: Biologic Sub-Study (PARC-B)

University of Pennsylvania

Status: Completed

Conditions: Psoriatic Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT03378336

828357

Details and patient eligibility

About

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.

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.

Enrollment: 171 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

171 participants in 1 patient group

Observational Group

Description:

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