NCT03620188

Brief Summary

The PaGoPsA study objective is to ascertain if guideline-based psoriatic arthritis clinical care achieves individual patient goals as articulated by patients, and to identify predictors of achieving individual patient goals from psoriatic arthritis treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

August 3, 2018

Last Update Submit

September 18, 2023

Conditions

Keywords

Patient treatment goals

Outcome Measures

Primary Outcomes (1)

  • Predictors of reaching PsA treatment goals/treatment success from a patient perspective.

    The primary outcome determination is based on the patients' report of whether they are/are not at goal with their PsA treatment.

    12-16 weeks

Secondary Outcomes (5)

  • To define a status of PsA treatment where patient treatment goals have been met.

    52 weeks

  • Improvement thresholds (treatment success) that correspond to a patient transition from goals not met to met.

    12-16 weeks

  • Worsening thresholds (treatment failure) if transition is from goals met to not met.

    12-16 weeks

  • Prevalence of treatment success in guideline -based treatment in psoriatic arthritis from the patients' perspective

    52 weeks

  • Stability of a state of treatment goals met at subsequent study visits.

    52 weeks

Interventions

Standard of care in PsA is outline in treatment guidelines as adjustment of therapy every 3 months until goals of treatment are being met. Goals of treatment are defined as remission or low disease activity.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with a diagnosis of psoriatic arthritis meeting CASPAR classification criteria for psoriatic arthritis who are followed every 3-4 months for regular rheumatologic care. Consecutive clinic patients will be recruited.

You may qualify if:

  • English speaking/reading adults
  • Patients of the Johns Hopkins Arthritis Center and/or the Johns Hopkins Psoriatic Arthritis Clinical Program
  • Followed every 3-4 months for regular psoriatic arthritis clinical care
  • Meet Classification Criteria for Psoriatic Arthritis (CASPAR)
  • Able to interact with touch screen computer.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Orbai AM, de Wit M, Mease P, Shea JA, Gossec L, Leung YY, Tillett W, Elmamoun M, Callis Duffin K, Campbell W, Christensen R, Coates L, Dures E, Eder L, FitzGerald O, Gladman D, Goel N, Grieb SD, Hewlett S, Hoejgaard P, Kalyoncu U, Lindsay C, McHugh N, Shea B, Steinkoenig I, Strand V, Ogdie A. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Ann Rheum Dis. 2017 Apr;76(4):673-680. doi: 10.1136/annrheumdis-2016-210242. Epub 2016 Sep 9.

    PMID: 27613807BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Ana-Maria Orbai, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 8, 2018

Study Start

December 20, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations