Centrum för reumatologi
Stockholm, Sweden
Location status: Recruiting
NCT Number: NCT06594861
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Stockholm, Sweden
Location status: Recruiting
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To be included in the risk group, the following criteria must be met:
To be included in the control group, the individual must:
Exclusion criteria
No intervention.
Time frame: From enrolment to a maximum of 9 years of follow-up.
The number of participants that develop rheumatic disease among the individuals with autoantibodies will be assessed
Time frame: From enrolment to a maximum of 9 years of follow-up.
The frequencies of clinical signs and symtoms thought to be related to anti-SSA/Ro and anti-SSB/La autoantibodies will be assessed
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
Follow-up of Clinical Manifestations and Inflammation-related Parameters in Individuals with Autoantibodies Against Ro/SSA and La/SSB
Acronym: ProgreSS
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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