Clinical trial NCT03378336: Psoriatic Arthritis Research Collaborative: Biologic Sub-Study
Official title: Psoriatic Arthritis Research Collaborative: Biologic Sub-Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: NYU Langone Health
name: University of Utah
First posted: 2017-12-19
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatology clinic patients with active PsA switching to or adding a TNFi.

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.

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

Primary outcomes:
measure: Patient Function Response to Biologic Therapy as Measured by RAPID3
timeFrame: 3 Months
Secondary outcomes:
measure: Patient Function Response to Biologic Therapy as Measured by HAQ-DI
timeFrame: 3 Months
measure: Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10
timeFrame: 3 Months
measure: Patient Quality of Life Response to Biologic Therapy as Measured by PSAID
timeFrame: 3 Months
measure: Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count.
timeFrame: 3 Months
measure: Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count.
timeFrame: 3 Months
measure: Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment
timeFrame: 3 Months
measure: Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment
timeFrame: 3 Months
measure: Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment
timeFrame: 3 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Hospital at the University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Pennsylvania
name: Alexis Ogdie, MD
role: PRINCIPAL_INVESTIGATOR
References: