Peripheral EnthesesNCT02038426
Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not
A study testing BLOOD SAMPLES, Radiographs of the sacroiliac joints and Radiographs of heels in people with Peripheral Entheses, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Purpose: Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not Comparison of the ultrasound semiology of enthesitis in the 3 populations Comparison of the MASEI scores in the 3 populations Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Entheses
- What is being tested?
- BLOOD SAMPLES, Radiographs of the sacroiliac joints and Radiographs of heels
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jan 2015
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Axial spondyloarthritis according to the ASAS classification criteria
- 18-45 years old
- Athletes are defined by sport activities greater than or equal to 6 hours per week
- Non athletes are defined by sport activities lesser than or equal to 1 hour per week
Who cannot join
- - History of heel or ankle surgery
- Recent corticosteroid infiltration of the heel or the ankle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.
Purpose:
- Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not
- Comparison of the ultrasound semiology of enthesitis in the 3 populations
- Comparison of the MASEI scores in the 3 populations
- Conditions
- Peripheral Entheses
- Being tested
- BLOOD SAMPLES, Radiographs of the sacroiliac joints, Radiographs of heels, SCAN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOOD SAMPLESBiological
Radiographs of the sacroiliac jointsDevice
Radiographs of heelsDevice
SCANDevice
| Study group | Role | What they receive |
|---|---|---|
| the patients with SpA | Experimental | Not described Receives: Biological: BLOOD SAMPLES; Device: Radiographs of the sacroiliac joints; Device: Radiographs of heels; Device: SCAN |
| sports subjects | Experimental | Not described Receives: Biological: BLOOD SAMPLES; Device: Radiographs of the sacroiliac joints; Device: Radiographs of heels; Device: SCAN |
| control subjects | Other | Not described Receives: Biological: BLOOD SAMPLES; Device: Radiographs of the sacroiliac joints; Device: Radiographs of heels; Device: SCAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
enthesitis detection
Number of subject having at least an enthesitis in every group of subjects
Measured: 12 months
Secondary outcomes (1)
MASEI scores
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral EnthesesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038426
- Sponsor's protocol ID
- 2013-A00759-36
- Other IDs
- 2013-27
- Status last verified
- Jun 2016
- First submitted
- 1 Aug 2013
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.
- ClinicalTrials.gov ID
- NCT02038426
- Acronym / sponsor ID
- 2013-A00759-36
- Conditions
- Peripheral Entheses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jan 2014 (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.
Purpose:
- Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not
- Comparison of the ultrasound semiology of enthesitis in the 3 populations
- Comparison of the MASEI scores in the 3 populations
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the patients with SpA | Experimental | Biological: BLOOD SAMPLES, Device: Radiographs of the sacroiliac joints, Device: Radiographs of heels, Device: SCAN |
| sports subjects | Experimental | Biological: BLOOD SAMPLES, Device: Radiographs of the sacroiliac joints, Device: Radiographs of heels, Device: SCAN |
| control subjects | Other | Biological: BLOOD SAMPLES, Device: Radiographs of the sacroiliac joints, Device: Radiographs of heels, Device: SCAN |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- - Axial spondyloarthritis according to the ASAS classification criteria
- 18-45 years old
- Athletes are defined by sport activities greater than or equal to 6 hours per week
- Non athletes are defined by sport activities lesser than or equal to 1 hour per week
Key exclusion criteria (2 listed)
- - History of heel or ankle surgery
- Recent corticosteroid infiltration of the heel or the ankle
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 |
|---|---|---|
| BLOOD SAMPLES | Biological | control subjects, sports subjects, the patients with SpA |
| Radiographs of the sacroiliac joints | Device | control subjects, sports subjects, the patients with SpA |
| Radiographs of heels | Device | control subjects, sports subjects, the patients with SpA |
| SCAN | Device | control subjects, sports subjects, the patients with SpA |
Primary outcome
enthesitis detection
Time frame: 12 months
Number of subject having at least an enthesitis in every group of subjects
1 secondary outcome
MASEI scores
Time frame: 12 months
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 13 Jun 2016.
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.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLOOD SAMPLES, Radiographs of the sacroiliac joints and Radiographs of heels in people with Peripheral Entheses, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 2 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 13 Jun 2016. 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 France. 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?
enthesitis detection (time frame: 12 months). 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 13 Jun 2016.