Follow-up Study of Individuals with Autoantibodies Against Ro/SSA and La/SSB

NCT06594861 | Recruiting

• 1 other identifier: 2023-04569-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoantibodies

Outcome Measures

Primary Outcomes (1)

• Development of a rheumatic disease

  The number of participants that develop rheumatic disease among the individuals with autoantibodies will be assessed

  From enrolment to a maximum of 9 years of follow-up.

Secondary Outcomes (1)

• Frequency of clinical symptoms

  From enrolment to a maximum of 9 years of follow-up.

Study Arms (2)

Individuals with autoantibodies against Ro/SSA and/or La/SSB

Other: No intervention

Individuals without autoantibodies against Ro/SSA and/or La/SSB

Other: No intervention

Interventions

No intervention OTHER

No intervention.

Individuals with autoantibodies against Ro/SSA and/or La/SSB; Individuals without autoantibodies against Ro/SSA and/or La/SSB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• To be included in the risk group, the following criteria must be met:
• \- At least one instance of testing positive for Ro/SSA or La/SSB, regardless of the method used.
• To be included in the control group, the individual must:
• \- Have no rheumatologic disease and no autoantibodies against Ro/SSA or La/SSB.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Centrum för reumatologi

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sampling includes tubes for serum, plasma, RNA and DNA extraction, as well as for cell separation.

Central Study Contacts

Albin Björk, MD, PhD

CONTACT

+46 8-123 687 04; albin.bjork@ki.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: February 9, 2024
• Primary Completion (Estimated): December 1, 2038
• Study Completion (Estimated): December 1, 2038
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)