Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-14 @ 10:15 PM
Study NCT ID:
NCT06594861
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up Study of Individuals with Autoantibodies Against Ro/SSA and La/SSB
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Follow-up of Clinical Manifestations and Inflammation-related Parameters in Individuals with Autoantibodies Against Ro/SSA and La/SSB
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProgreSS
Brief Summary:
In this study, individuals with autoantibodies against Ro/SSA and La/SSB 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, Ro/SSA and La/SSB, are often present.
It is well known that some individuals with autoantibodies against Ro/SSA and/or La/SSB 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 Ro/SSA and/or La/SSB 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 Ro/SSA and La/SSB. 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 Ro/SSA and/or La/SSB 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 (i.e., 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 Ro/SSA and/or La/SSB 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 Ro/SSA and/or La/SSB 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 Ro/SSA and La/SSB. 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 Ro/SSA and/or La/SSB 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 (i.e., 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:
False
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?:
False
Is an FDA AA801 Violation?: