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NCT Number: NCT03040583

The ASSESS National Multi-center Prospective Cohort

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.

Recruiting

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Key information

Conditions

Primary Sjögren's Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Bicêtre

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

Location status: Recruiting

Location contact

Xavier MARIETTE

CONTACT

[email protected]

01.45.21.37.58

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

No intervention

Other

Patients data will be collected during their disease follow-up

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. number of patients with cancer

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

    To analysis the incidence of cancer in patients with pSS.

  2. number of patients with cardiovascular complication

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

    To analysis the incidence of cardiovascular complications in patients with pSS.

  3. List of drugs taken by the patients

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

    To understand better the pathophysiology of the disease (new therapeutic targets for the pathology)

  4. Biological report (Blood test)

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

    To Evaluate the role of biomarkers

Study contacts

Contact information is provided by the study sponsor or research team.

Jacques-Eric Gottenberg

CONTACT

[email protected]

03.88.12.79.50

Xavier Mariette

CONTACT

[email protected]

01.45.21.37.58

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Societe Francaise de Rhumatologie

Registry information

Official study title

Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)

Acronym: ASSESS

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Feb 2, 2017
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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