Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594861
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Follow-up Study of Individuals with Autoantibodies Against RoSSA and LaSSB
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Follow-up of Clinical Manifestations and Inflammation-related Parameters in Individuals with Autoantibodies Against RoSSA and LaSSB
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProgreSS
Brief Summary:
In this study individuals with autoantibodies against RoSSA and LaSSB will be followed with regard to clinical manifestations and immunological parameters to identify immunological changes environmental factors and early clinical symptoms that characterize the progression from serological autoreactivity to clinically manifest disease
Detailed Description:
Autoimmune diseases are a diverse group of conditions characterized by chronic inflammation and tissue damage In systemic autoimmune diseases such as Sjögren disease and systemic lupus erythematosus SLE two specific types of autoantibodies targeting the bodys own proteins RoSSA and LaSSB are often present
It is well known that some individuals with autoantibodies against RoSSA andor LaSSB never develop any systemic rheumatic disease while in others the presence of these autoantibodies is a sign of impending disease The condition of so-called serological autoreactivity which can persist for decades and how clinical disease subsequently develops is very little studied There is currently a lack of knowledge regarding the environmental factors that contribute to the emergence of autoantibodies against RoSSA andor LaSSB and the immunological mechanisms that lead to disease development in some individuals but not in others
This project aims to enhance the understanding of the condition of serological autoreactivity against RoSSA and LaSSB The specific goal is to identify immunological changes environmental factors and early clinical symptoms that characterize the progression from serological autoreactivity to clinically apparent disease Understanding the immunological mechanisms that trigger the transition to disease is crucial for enabling earlier diagnosis and treatment as well as for better comprehending the fundamental mechanisms underlying the development of autoimmune disease
This will be achieved by
1 Clinically characterizing at-risk individuals who carry autoantibodies against RoSSA andor LaSSB through medical consultations at a rheumatology specialist clinic
2 Immunologically characterizing at-risk individuals in comparison with healthy individuals through blood sampling and immunological analyses
3 Collecting data on exposure to environmental and lifestyle factors that could potentially increase the risk of autoimmunity
Study participants are offered annual follow-up assessments for four years after the inclusion visit ie a total of 4 study visits per participant Participants that develop new symptoms during the study are be offered additional medical visits for assessment At the final follow-up visit participants will be asked for their consent to be contacted by phone to inquire about any new symptoms and to schedule new blood tests after two and five years respectively
It is well known that some individuals with autoantibodies against RoSSA andor LaSSB never develop any systemic rheumatic disease while in others the presence of these autoantibodies is a sign of impending disease The condition of so-called serological autoreactivity which can persist for decades and how clinical disease subsequently develops is very little studied There is currently a lack of knowledge regarding the environmental factors that contribute to the emergence of autoantibodies against RoSSA andor LaSSB and the immunological mechanisms that lead to disease development in some individuals but not in others
This project aims to enhance the understanding of the condition of serological autoreactivity against RoSSA and LaSSB The specific goal is to identify immunological changes environmental factors and early clinical symptoms that characterize the progression from serological autoreactivity to clinically apparent disease Understanding the immunological mechanisms that trigger the transition to disease is crucial for enabling earlier diagnosis and treatment as well as for better comprehending the fundamental mechanisms underlying the development of autoimmune disease
This will be achieved by
1 Clinically characterizing at-risk individuals who carry autoantibodies against RoSSA andor LaSSB through medical consultations at a rheumatology specialist clinic
2 Immunologically characterizing at-risk individuals in comparison with healthy individuals through blood sampling and immunological analyses
3 Collecting data on exposure to environmental and lifestyle factors that could potentially increase the risk of autoimmunity
Study participants are offered annual follow-up assessments for four years after the inclusion visit ie a total of 4 study visits per participant Participants that develop new symptoms during the study are be offered additional medical visits for assessment At the final follow-up visit participants will be asked for their consent to be contacted by phone to inquire about any new symptoms and to schedule new blood tests after two and five years respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None