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
• Results First Submitted: 2024-07-17
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Results First Posted: 2025-05-09
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

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 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.

Secondary Outcome Measures

Name	Time	Method
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 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.
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 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.
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 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).
Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count.	3 Months	Physician assessment of disease activity as measured by change in swollen joint count from baseline to 3 months.
Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count.	3 Months	Physician assessment of disease activity as measured by change in tender joint count from baseline to 3 months.
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 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.
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 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.
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 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.

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