Primary Sjögren SyndromeAMISSNCT03126383
Inflammatory Myopathies in Primary Sjögren's Syndrome
An observational study of Primary Sjögren Syndrome, run by University Hospital, Brest at 1 site in France.
Trial summary
The AMISS study will characterize the features of muscle disease in patients with primary Sjogren's syndrome (pSS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren Syndrome
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2017to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Sjögren's syndrome
Who may be able to join
- diagnosis of Primary Sjögren's syndrome according to the ACR/EULAR classification criteria
- inflammatory muscle involvement, as diagnosed by the treating physician
Who cannot join
- Diagnosis of inflammatory myopathy before the diagnosis of pSS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Inflammatory Muscle Involvement in Patients With Primary Sjögren's Syndrome
The AMISS study will characterize the features of muscle disease in patients with primary Sjogren's syndrome (pSS).
Read the detailed description
Muscle disease is associated with pSS, but this association is not well defined. The AMISS study, a retrospective observational multicentric study, will recruit patients with pSS and muscle involvement in order to characterize in details the features of this association (epidemiological aspects, clinical presentation, biological, radiological and histological findings, treatments and outcomes).
- Conditions
- Primary Sjögren Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients fulfilling classification criteria for inflammatory myopathies
Among the patients included in the AMISS study, we will assess the proportion of patients who fulfill the classification criteria for the different inflammatory myopathies.
Measured: At diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start16 Mar 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126383
- Sponsor's protocol ID
- AMISS (29BRC17.0031)
- Acronym
- AMISS
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2017
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Inflammatory Muscle Involvement in Patients With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT03126383
- Acronym / sponsor ID
- AMISS / AMISS (29BRC17.0031)
- Conditions
- Primary Sjögren Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- 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.
The AMISS study will characterize the features of muscle disease in patients with primary Sjogren's syndrome (pSS).
Detailed description
Muscle disease is associated with pSS, but this association is not well defined. The AMISS study, a retrospective observational multicentric study, will recruit patients with pSS and muscle involvement in order to characterize in details the features of this association (epidemiological aspects, clinical presentation, biological, radiological and histological findings, treatments and outcomes).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Sjögren's syndrome
Key inclusion criteria (2 listed)
- diagnosis of Primary Sjögren's syndrome according to the ACR/EULAR classification criteria
- inflammatory muscle involvement, as diagnosed by the treating physician
Key exclusion criteria (1 listed)
- Diagnosis of inflammatory myopathy before the diagnosis of pSS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients fulfilling classification criteria for inflammatory myopathies
Time frame: At diagnosis
Among the patients included in the AMISS study, we will assess the proportion of patients who fulfill the classification criteria for the different inflammatory myopathies.
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 25 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Primary Sjögren Syndrome, run by University Hospital, Brest 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 2 inclusion and 1 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 25 Jun 2026. 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?
Proportion of patients fulfilling classification criteria for inflammatory myopathies (time frame: At diagnosis). 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 25 Jun 2026.