Primary Sjögren's SyndromeASSESSNCT03040583
The ASSESS National Multi-center Prospective Cohort
An observational study of Primary Sjögren's Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjögren's Syndrome "SS") was set up in 2006 thanks to a grant of the French Ministry of Health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren's Syndrome
- How many people
- 395 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Sep 2030
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: expected population number is 395 patients
Who may be able to join
- aged of 18 years or more
- Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
Who cannot join
- secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, 94270
Xavier MARIETTE, 01.45.21.37.58, xavier.mariette@aphp.fr
About this study
Official title: Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)
The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjögren's Syndrome "SS") was set up in 2006 thanks to a grant of the French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included consecutive patients with Primary Sjögren's Syndrome "pSS" fulfilling American-European Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This study was followed for 5 years with the grant of the French Ministry of Health and this study will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for a duration of 20 years, a thorough standardized paper case report form (CRF) was filled prospectively by clinicians.
Read the detailed description
Primary Sjögren's syndrome (pSS) affects 0,1% of the population. This systemic autoimmune disease is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. The previous or present systemic complications included skin, articular, lung, kidney, peripheral and central nervous system, muscular involvement and vasculitis, as well as lymphoma occurrence were recorded. For previous lymphoma, the diagnosis and the histological subtypes were confirmed by reanalysis of the medical and histological records. The objective of this cohort was to assess systemic complications (signs) and evolution of patients with pSS and to determine the evolution and factors predictors of lymphoma of systemic complications and lymphoma in pSS during a 20-years prospective follow-up. This cohort was successful in rheumatology field, 395 patients was recruited for 2 years in 15 French centers (10 rheumatology and internal medicine 5) and followed for 5 years until July 2014.
The primary objective of this cohort is to assess the evolution of Primitive Sjogren Syndrome patients and to determine predictors factors of lymphoma and systemic complications during a 20-years prospective follow-up.
- Conditions
- Primary Sjögren's Syndrome
- Being tested
- No intervention
- Keywords
- Primary Sjögren's syndrome (PSS), auto-immune diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Patients data will be collected during their disease follow-up
| Study group | Role | What they receive |
|---|---|---|
| ASSESS (PHRC) patients | Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with systemic complications during the follow-up assessed with European League Against Rheumatism (EULAR) Sjögren Syndrome Disease Activity index (ESSDAI) activity score and ESSPRI score
To assess the evolution of patients with primary Sjogren's Syndrome, determine the incidence of systemic complications
Measured: From the beginning of the study until the end of the 20 years follow-up
Variation of complications during the follow-up assessed with ESSDAI activity score and EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score
Measured: From the beginning of the study until the end of the 20 years follow-up
number of patient developing a lymphoma
To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome
Measured: From the beginning of the study until the end of the 20 years follow-up
Secondary outcomes (4)
number of patients with cancer
To analysis the incidence of cancer in patients with pSS.
Measured: From the beginning of the study until the end of the 20 years follow-up
number of patients with cardiovascular complication
To analysis the incidence of cardiovascular complications in patients with pSS.
Measured: From the beginning of the study until the end of the 20 years follow-up
List of drugs taken by the patients
To understand better the pathophysiology of the disease (new therapeutic targets for the pathology)
Measured: From the beginning of the study until the end of the 20 years follow-up
Biological report (Blood test)
To Evaluate the role of biomarkers
Measured: From the beginning of the study until the end of the 20 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startSep 2016
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 395 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie
- Responsible party
- Sponsor
- Investigators
- Xavier Mariette, Principal investigator, SFR/AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040583
- Sponsor's protocol ID
- P060228
- Acronym
- ASSESS
- Status last verified
- Mar 2020
- First submitted
- 13 Jan 2017
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Szafors P, Lukas C, Combe B, Gottenberg JE, Mariette X, Seror R, Morel J. Stability and prognostic value of B-cell markers in primary SS: results from the French ASSESS cohort. Rheumatology (Oxford). 2026 Jun 30;65(7):keag339. doi: 10.1093/rheumatology/keag339.
PubMed 42384910Duret PM, Schleiss C, Kawka L, Meyer N, Ye T, Saraux A, Devauchelle-Pensec V, Seror R, Larroche C, Perdriger A, Sibilia J, Vallat L, Fornecker LM, Nocturne G, Mariette X, Gottenberg JE. Association Between Bruton's Tyrosine Kinase Gene Overexpression and Risk of Lymphoma in Primary Sjogren's Syndrome. Arthritis Rheumatol. 2023 Oct;75(10):1798-1811. doi: 10.1002/art.42550. Epub 2023 Jul 28.
PubMed 37115807
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)
- ClinicalTrials.gov ID
- NCT03040583
- Acronym / sponsor ID
- ASSESS / P060228
- Conditions
- Primary Sjögren's Syndrome
- Keywords
- Primary Sjögren's syndrome (PSS), auto-immune diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie
- Study start
- Sep 2016
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 2 Feb 2017 (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.
The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjögren's Syndrome "SS") was set up in 2006 thanks to a grant of the French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included consecutive patients with Primary Sjögren's Syndrome "pSS" fulfilling American-European Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This study was followed for 5 years with the grant of the French Ministry of Health and this study will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for a duration of 20 years, a thorough standardized paper case report form (CRF) was filled prospectively by clinicians.
Detailed description
Primary Sjögren's syndrome (pSS) affects 0,1% of the population. This systemic autoimmune disease is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. The previous or present systemic complications included skin, articular, lung, kidney, peripheral and central nervous system, muscular involvement and vasculitis, as well as lymphoma occurrence were recorded. For previous lymphoma, the diagnosis and the histological subtypes were confirmed by reanalysis of the medical and histological records. The objective of this cohort was to assess systemic complications (signs) and evolution of patients with pSS and to determine the evolution and factors predictors of lymphoma of systemic complications and lymphoma in pSS during a 20-years prospective follow-up. This cohort was successful in rheumatology field, 395 patients was recruited for 2 years in 15 French centers (10 rheumatology and internal medicine 5) and followed for 5 years until July 2014.
The primary objective of this cohort is to assess the evolution of Primitive Sjogren Syndrome patients and to determine predictors factors of lymphoma and systemic complications during a 20-years prospective follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASSESS (PHRC) patients | – | Other: No interventionPrimary Sjögren's Syndrome Patients who have already participated to the study ASSESS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- expected population number is 395 patients
Key inclusion criteria (2 listed)
- aged of 18 years or more
- Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
Key exclusion criteria (1 listed)
- secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases
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 |
|---|---|---|
| No interventionPatients data will be collected during their disease follow-up | Other | ASSESS (PHRC) patients |
Primary outcome
Number of patients with systemic complications during the follow-up assessed with European League Against Rheumatism (EULAR) Sjögren Syndrome Disease Activity index (ESSDAI) activity score and ESSPRI score
Time frame: From the beginning of the study until the end of the 20 years follow-up
To assess the evolution of patients with primary Sjogren's Syndrome, determine the incidence of systemic complications
Variation of complications during the follow-up assessed with ESSDAI activity score and EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score
Time frame: From the beginning of the study until the end of the 20 years follow-up
number of patient developing a lymphoma
Time frame: From the beginning of the study until the end of the 20 years follow-up
To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome
4 secondary outcomes
number of patients with cancer
Time frame: From the beginning of the study until the end of the 20 years follow-up
number of patients with cardiovascular complication
Time frame: From the beginning of the study until the end of the 20 years follow-up
List of drugs taken by the patients
Time frame: From the beginning of the study until the end of the 20 years follow-up
Biological report (Blood test)
Time frame: From the beginning of the study until the end of the 20 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Derived from this study: PubMed 42384910Szafors P, Lukas C, Combe B, Gottenberg JE, Mariette X, Seror R, Morel J. Stability and prognostic value of B-cell markers in primary SS: results from the French ASSESS cohort. Rheumatology (Oxford). 2026 Jun 30;65(7):keag339. doi: 10.1093/rheumatology/keag339.
- Derived from this study: PubMed 37115807Duret PM, Schleiss C, Kawka L, Meyer N, Ye T, Saraux A, Devauchelle-Pensec V, Seror R, Larroche C, Perdriger A, Sibilia J, Vallat L, Fornecker LM, Nocturne G, Mariette X, Gottenberg JE. Association Between Bruton's Tyrosine Kinase Gene Overexpression and Risk of Lymphoma in Primary Sjogren's Syndrome. Arthritis Rheumatol. 2023 Oct;75(10):1798-1811. doi: 10.1002/art.42550. Epub 2023 Jul 28.
- Individual participant dataSharing planned: No
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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.
Xavier Mariette principal investigator
SFR/AP-HP
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's Syndrome, run by Assistance Publique - Hôpitaux de Paris 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: looking for participants now, as of the sponsor's last update on 13 Mar 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Mariette (01.45.21.37.58, xavier.mariette@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with systemic complications during the follow-up assessed with European League Against Rheumatism (EULAR) Sjögren Syndrome Disease Activity index (ESSDAI) activity score and ESSPRI score (time frame: From the beginning of the study until the end of the 20 years follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040583, which also lists 2 linked publications.
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 Mar 2020.