Psoriatic Arthritis Research Collaborative: Biologic Sub-Study

NCT03378336 | Completed Results

• 1 other identifier: 828357
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 4

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.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 Months

Secondary Outcomes (8)

• Patient Function Response to Biologic Therapy as Measured by HAQ-DI

  3 Months

• Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10

  3 Months

• Patient Quality of Life Response to Biologic Therapy as Measured by PSAID

  3 Months

• Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count.

  3 Months

• Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count.

  3 Months

Study Arms (1)

Observational Group

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rheumatology clinic patients with active PsA switching to or adding a TNFi.

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• The Cleveland Clinic: collaborator
• NYU Langone Health: collaborator
• University of Utah: collaborator

Study Sites (4)

NYU School of Medicine

New York, New York, 10003, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• Reddy SM, Xue K, Husni ME, Scher JU, Stephens-Shields AJ, Goel N, Koplin J, Craig ET, Walsh JA, Ogdie A. Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease. J Rheumatol. 2024 Feb 1;51(2):139-143. doi: 10.3899/jrheum.2023-0504.

  PMID: 38101918 DERIVED

Related Links

• Responsiveness and Minimum Clinically Important Difference in Patient-Reported Outcome Measures Among Patients With Psoriatic Arthritis: A Prospective Cohort Study
• Use of the Bath Ankylosing Spondylitis Disease Activity Index in Patients With Psoriatic Arthritis With and Without Axial Disease

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 40 mL (4 tubes) of blood will be drawn at each of 2 visits. The blood and information collected throughout this study will be used to build a repository for future research projects. The de-identified information stored in the redcap will available only to the study teams at each of the sites involved in this study and to those PIs for future research. Blood samples will be processed and stored at individual sites. De-identified blood samples may be shipped to a central location for further testing on bio-markers of treatment response and disease progression. Participants may retract permission and ask that their samples be destroyed. Information from these samples is exploratory and will not be shared with participants or included in medical records

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

171 unique participants were enrolled in the study, but there were 266 instances of treatment initiation analyzed (each participant could initiate \>1 therapy). Of the 266 instances of treatment initiation, not all outcome measures were completed at both Baseline and Month 3. Therefore, some outcome measures have a smaller number of units analyzed to include only those completed at both timepoints.

Results Point of Contact

• Title: Dr. Alexis Ogdie-Beatty
• Organization: University of Pennsylvania

alexis.ogdie@pennmedicine.upenn.edu

215-614-2454

Study Officials

• Alexis Ogdie, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 19, 2017
• Study Start: December 31, 2017
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2023
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: This data will be accessible throughout and after completion of the study.
• Access Criteria: The de-identified information stored in the redcap will available only to the study teams at each of the sites involved in this study and to those PIs for future research. Researchers not involved in this study will not be permitted to request or use data or samples from this study.

Locations

US (4)