Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)
The ASSESS National Multi-center Prospective Cohort
Sponsors
Source
Assistance Publique - Hôpitaux de Paris
Oversight Info
Has Dmc
Yes
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.
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.
Overall Status
Recruiting
Start Date
2016-09-01
Completion Date
2030-09-01
Primary Completion Date
2030-09-01
Study Type
Observational [Patient Registry]
Primary Outcome
Measure |
Time Frame |
|
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 |
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 |
From the beginning of the study until the end of the 20 years follow-up |
Secondary Outcome
Measure |
Time Frame |
|
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 |
Number Of Groups
1
Enrollment
395
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
Patients data will be collected during their disease follow-up
Arm Group Label
ASSESS (PHRC) patients
Eligibility
Study Pop
expected population number is 395 patients
Sampling Method
Probability Sample
Criteria
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Xavier Mariette |
Principal Investigator |
SFR/AP-HP |
Overall Contact
Location
Facility |
Status |
Contact |
|
Hopital Bicêtre Le Kremlin Bicêtre Val De Marne 94270 France |
Recruiting |
Location Countries
Country
France
Verification Date
2017-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
ASSESS (PHRC) patients
Description
Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
Firstreceived Results Date
N/A
Overall Contact Backup
Acronym
ASSESS
Target Duration
20 Years
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
January 13, 2017
Study First Submitted Qc
January 31, 2017
Study First Posted
February 2, 2017
Last Update Submitted
February 20, 2017
Last Update Submitted Qc
February 20, 2017
Last Update Posted
February 23, 2017
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.