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.
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 Type
OBSERVATIONAL
Enrollment
171
NYU School of Medicine
New York, New York, United States
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
Patient Function Response to Biologic Therapy as Measured by RAPID3
Patient's perception of response to therapy as related to patient functionality. Measured by a change in RAPID3 score from baseline to 3 month visit. RAPID3 (Routine Assessment of Patient Index Data 3) is a pooled index of the 3 patient-reported American College of Rheumatology Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: \>12 = high; 6.1-12 = moderate; 3.1-6 = low; \< or =3 = remission.
Time frame: 3 Months
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 change in HAQ-DI score from baseline to 3 month visit. The HAQ-DI (Health Assessment Questionnaire - Disability Index) covers 20 items in eight domains related to measuring difficulty in performing activities of daily living. Each question is rated on a 0-3 scale, where 0 indicates "without difficulty" and 3 indicates "unable to do." The highest score in each domain is accepted as the score in that domain. Scores for the 8 domains are averaged to compute final score between 0 and 3. Scores 0-1 indicate mild to moderate disability, 1-2 indicate moderate to severe disability, and 2-3 indicate severe to very severe disability.
Time frame: 3 Months
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 change in PROMIS10 Physical Health score from baseline to 3 month visit. PROMIS10 (Patient-Reported Outcomes Measurement Information System) Physical Health is a 10-item questionnaire, each with a five point scale from Poor to Excellent. PROMIS uses Item Response Theory (IRT) statistical model that links individual questions to a presumed underlying trait or concept of global health represented by all items in the scale; instruments are scored using item-level calibrations ("response pattern scoring") in an online tool (T-Score range 0-100). Increasing score indicates improvement.
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Time frame: 3 Months
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 change in PSAID score from baseline to 3 month visit. PSAID (PsA Impact of Disease) is a questionnaire composed of 12 health domains, examining different perspectives (both physical and psychological). Each domain is evaluated by a single question with a range from 0-10 in which higher results indicate a greater impact of the disease. Individual domain scores are weighted to indicate those with a greater effect, then the sum of weighted domain scores is divided by 20 to compute the final score (range 0-10).
Time frame: 3 Months
Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count.
Physician assessment of disease activity as measured by change in swollen joint count from baseline to 3 months.
Time frame: 3 Months
Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count.
Physician assessment of disease activity as measured by change in tender joint count from baseline to 3 months.
Time frame: 3 Months
Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment
Disease Activity and Response to Biologic Therapy as measured by change in Patient Pain Assessment from baseline to 3 month visit. The Patient Pain Assessment is measured on a scale of 0-100 where a higher score indicates worse pain.
Time frame: 3 Months
Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment
Disease Activity and Response to Biologic Therapy as measured by change in Physician Global Assessment from baseline to 3 month visit. Physician Global Assessment is measured on a scale from 0-10 where a higher score indicates greater disease impact.
Time frame: 3 Months
Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment
Disease Activity and Response to Biologic Therapy as measured by change in Patient Global Assessment from baseline to 3 month visit. Patient Global Assessment is measured on a scale of 0-10 where a higher score indicates greater disease impact.
Time frame: 3 Months