NCT01654198

Brief Summary

When patients with psoriasis develop joint pain, it is often hard to decide whether or not the pain is due to psoriatic arthritis (PsA). At this time, doctors use information from the history and physical exam to determine the diagnosis. X-rays, magnetic resonance imaging (MRI) and ultrasound have been used to help with the diagnosis but all three have limitations. A newer imaging technique, whole body Positron Emission Tomography/Computed Tomography (PET/CT) uses the idea that inflammatory cells take up sugar to locate inflammation in the body. Because patients with PsA have inflammatory cells in their joints and tendons, this type of scan allows the physician to take a picture of the whole body and locate inflammation. The investigators have found that some patients with psoriasis (but without arthritis) have inflammation in joints and tendons even before the patient has symptoms. In this study, the investigators will explore how well PET/CT works for assessing inflammation in patients with PsA. This would be a very exciting tool that could be used to find and treat inflammation before it causes damage or pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 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

Study Start

First participant enrolled

July 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2018

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

6.3 years

First QC Date

July 27, 2012

Last Update Submit

December 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary outcome is inflammation as measured by SUVmax and metabolic volumetric product in the joints and entheses.

    At the discretion of the PI

Secondary Outcomes (1)

  • Correlation of local inflammation in joints and enthesis with systemic inflammatory markers including IL6 and high sensitivity CRP.

    At the discretion of the PI

Study Arms (1)

Psoriatic arthritis

Radiation: FDG-PET/CT scan

Interventions

FDG-PET/CT is a type of imaging used currently to look for cancer. We are using it to look at inflammation within the joints.

Psoriatic arthritis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with psoriatic arthritis defined by CASPAR criteria and active joint disease.

You may qualify if:

  • Age 18-80,
  • active psoriatic arthritis (joint or enthesis inflammation)

You may not qualify if:

  • Diabetes,
  • pregnant,
  • no active PsA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Division of Rheumatology

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, and Plasma Cells

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alexis R Ogdie, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2012

First Posted

July 31, 2012

Study Start

July 1, 2012

Primary Completion

October 2, 2018

Study Completion

October 2, 2018

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations