Psoriatic ArthritisNCT01654198
PET/CT in Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- FDG-PET/CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 2 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with psoriatic arthritis defined by CASPAR criteria and active joint disease.
Who may be able to join
- Age 18-80,
- active psoriatic arthritis (joint or enthesis inflammation)
Who cannot join
- Diabetes,
- pregnant,
- no active PsA
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Division of Rheumatology
Philadelphia, Pennsylvania, 19104
About this study
Official title: FDG-PET/CT in the Diagnosis and Monitoring of Psoriatic Arthritis
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.
- Conditions
- Psoriatic Arthritis
- Being tested
- FDG-PET/CT scan
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET/CT scanRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis | Not described Receives: Radiation: FDG-PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is inflammation as measured by SUVmax and metabolic volumetric product in the joints and entheses.
Measured: 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.
Measured: At the discretion of the PI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis R Ogdie, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654198
- Sponsor's protocol ID
- 815253
- Status last verified
- Dec 2020
- First submitted
- 27 Jul 2012
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG-PET/CT in the Diagnosis and Monitoring of Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT01654198
- Acronym / sponsor ID
- 815253
- Conditions
- Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis | – | Radiation: FDG-PET/CT scan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with psoriatic arthritis defined by CASPAR criteria and active joint disease.
Key inclusion criteria (2 listed)
- Age 18-80,
- active psoriatic arthritis (joint or enthesis inflammation)
Key exclusion criteria (3 listed)
- Diabetes,
- pregnant,
- no active PsA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG-PET/CT scanFDG-PET/CT is a type of imaging used currently to look for cancer. We are using it to look at inflammation within the joints. | Radiation | Psoriatic arthritis |
Primary outcome
Primary outcome is inflammation as measured by SUVmax and metabolic volumetric product in the joints and entheses.
Time frame: At the discretion of the PI
1 secondary outcome
Correlation of local inflammation in joints and enthesis with systemic inflammatory markers including IL6 and high sensitivity CRP.
Time frame: At the discretion of the PI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis R Ogdie, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome is inflammation as measured by SUVmax and metabolic volumetric product in the joints and entheses. (time frame: At the discretion of the PI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.