NCT03040583

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Sep 2016Sep 2030

Study Start

First participant enrolled

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

14 years

First QC Date

January 13, 2017

Last Update Submit

March 12, 2020

Conditions

Primary Sjögren's Syndrome

Keywords

Primary Sjögren's syndrome (PSS)auto-immune diseases

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    From the beginning of the study until the end of the 20 years follow-up

Secondary Outcomes (4)

  • number of patients with cancer

    From the beginning of the study until the end of the 20 years follow-up

  • number of patients with cardiovascular complication

    From the beginning of the study until the end of the 20 years follow-up

  • List of drugs taken by the patients

    From the beginning of the study until the end of the 20 years follow-up

  • Biological report (Blood test)

    From the beginning of the study until the end of the 20 years follow-up

Study Arms (1)

ASSESS (PHRC) patients

Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS

Other: No intervention

Interventions

No interventionOTHER

Patients data will be collected during their disease follow-up

ASSESS (PHRC) patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

expected population number is 395 patients

You may qualify if:

  • aged of 18 years or more
  • Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS

You may not qualify if:

  • secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Bicêtre

Le Kremlin-Bicêtre, Val De Marne, 94270, France

RECRUITING

Related Publications (1)

  • Duret 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.

    PMID: 37115807DERIVED

Study Officials

  • Xavier Mariette

    SFR/AP-HP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Mariette

CONTACT

01.45.21.37.58xavier.mariette@aphp.fr

Jacques-Eric Gottenberg

CONTACT

03.88.12.79.50jacques-Eric.gottenberg@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

February 2, 2017

Study Start

September 1, 2016

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)