N/A
N=171
Psoriatic Arthritis Research Collaborative: Biologic Sub-Study
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03378336 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Patient Function Response to Biologic Therapy as Measured by RAPID3 — -1.11 change in score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Function Response to Biologic Therapy as Measured by RAPID3 |
-1.11 | — |
| SECONDARY Patient Function Response to Biologic Therapy as Measured by HAQ-DI |
-0.07 | — |
| SECONDARY Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10 |
1.43 | — |
| SECONDARY Patient Quality of Life Response to Biologic Therapy as Measured by PSAID |
-0.30 | — |
| SECONDARY Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count. |
-0.81 | — |
| SECONDARY Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count. |
-0.63 | — |
| SECONDARY Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment |
-0.75 | — |
| SECONDARY Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment |
-0.30 | — |
| SECONDARY Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment |
-0.24 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03378336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.