PET/CT in Psoriatic Arthritis | NCT01654198

Studies
PET/CT in Psoriatic Arthritis

NCT01654198

Sponsor

University of Pennsylvania

Status

Completed

Last Update Posted

Dec 8, 2020Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Psoriatic Arthritis

Interventions

FDG-PET/CT scan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012Actual

Primary Completion Date

Oct 2, 2018Actual

Completion Date

Oct 2, 2018Actual

First Submitted Date

Jul 27, 2012

First Submission Date that Met QC Criteria

Jul 30, 2012

First Posted Date

Jul 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2020

Last Update Posted Date

Dec 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psoriatic arthritis			Radiation: FDG-PET/CT scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FDG-PET/CT scan	Radiation	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Correlation of local inflammation in joints and enthesis with systemic inflammatory markers including IL6 and high sensitivity CRP.		At the discretion of the PI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Diabetes,
pregnant,
no active PsA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexis R Ogdie, MD, MSCE	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania Division of Rheumatology		Philadelphia	Pennsylvania	19104	United States

Condition Browse Module

MeSH Terms

ID	Term
D015535	Arthritis, Psoriatic

Ancestor Terms

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided