NCT02470481

Brief Summary

The purpose of this study is to conduct full psychometric testing of the Early Arthritis for Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations

Trial Health

90
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 Mar 2015

Geographic Reach
3 countries

5 active sites

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

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

June 10, 2015

Last Update Submit

September 1, 2016

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Psoriatic Arthritis

    Percentage of participants with psoriatic arthritis will be assessed using formula: Number of participants diagnosed with psoriatic arthritis divided by total number of participants with psoriasis attending the dermatology clinic.

    Baseline up to Day 28

Study Arms (1)

Cohort 1

Participants with psoriatic arthritis among psoriasis particiants attending dermatology clinics.

Other: No Intervention

Interventions

No InterventionOTHER

This is an obervational study

Cohort 1

Eligibility Criteria

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

Participants with psoriatic arthritis among psoriasis participants attending dermatology clinics.

You may qualify if:

  • Patient must be a man or woman aged 18 to 65 years of age, inclusive
  • The patient must have an established diagnosis of psoriasis (based upon clinical evidence, and documented medical history \[19\])
  • The patient must be able to read and write in the target language (English, Mandarin or Korean; or other relevant target languages)
  • Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study

You may not qualify if:

  • An established diagnosis of psoriatic arthritis
  • Ever have received systemic treatment with a disease modifying antirheumatic drug (DMARD) for arthritis or spondylitis (inflammatory back pain)
  • Ever have received systemic treatment with a biologic therapy for psoriasis (including infliximab, golimumab, ustekinumab, adalimumab or etanercept)
  • A history of employment in or are currently employed in the healthcare industry; or
  • Participated in the translation and linguistic validation of the EARP questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Fitzroy, Australia

Location

Unknown Facility

New Lambton, Australia

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

  • Jo SJ, Foley P, Oakley SP, Zhang J, Zheng M, Shin K, McGonagle D, Gisondi P, Tinazzi I, Butcher BE, Handel M. Initial assessment of the early arthritis for psoriatic patients diagnostic questionnaire in dermatology clinics in Australia, Korea and China. Int J Rheum Dis. 2019 Aug;22(8):1512-1520. doi: 10.1111/1756-185X.13604. Epub 2019 May 22.

    PMID: 31115158DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 12, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 2, 2016

Record last verified: 2016-09

Locations

CN(2)KR(1)AU(2)