Follow-up Study of Individuals with Autoantibodies Against Ro/SSA and La/SSB
ConditionAutoantibodies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Below 18 years of age
Inability to consent to their own participation
Ongoing infection or severe illness where the study physician deems participation in the study not to be in the individuals best interest
Inability to read and understand Swedish, and therefore unable to complete the forms and questionnaires included in the project
Trial population
Individuals who have been evaluated at a rheumatology specialist clinic or followed by a pediatric cardiologist due to autoantibodies against Ro/SSA and/or La/SSB are invited to participate in the study. Healthy controls are invited through advertisements.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Individuals with autoantibodies against Ro/SSA and/or La/SSB1 intervention
Group B: Individuals without autoantibodies against Ro/SSA and/or La/SSB1 intervention
Trial outcomes
Primary outcomes
1
Development of a rheumatic disease
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.Secondary outcomes
1
Frequency of clinical symptoms
The frequencies of clinical signs and symtoms thought to be related to anti-SSA/Ro and anti-SSB/La autoantibodies will be assessed
Time frame
From enrolment to a maximum of 9 years of follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov