Following individuals with specific autoantibodies to understand disease progression
Follow-up of Clinical Manifestations and Inflammation-related Parameters in Individuals with Autoantibodies Against Ro/SSA and La/SSB
This study is tracking people with specific autoantibodies to see how their health changes over time and to learn more about the development of autoimmune diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06594861 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on individuals who have tested positive for autoantibodies against Ro/SSA and La/SSB. Participants will be monitored to assess clinical manifestations and immunological parameters, aiming to identify changes and factors that may lead to the development of autoimmune diseases. The study seeks to enhance understanding of the transition from serological autoreactivity to clinically manifest disease, which is currently poorly understood. By investigating these aspects, the research aims to provide insights that could facilitate earlier diagnosis and treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals who have tested positive for Ro/SSA or La/SSB autoantibodies.
Not a fit: Patients who do not have any rheumatologic disease or autoantibodies against Ro/SSA or La/SSB may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and earlier intervention for individuals at risk of developing autoimmune diseases.
How similar studies have performed: While there is limited research specifically on this transition, studies on autoimmune diseases have shown varying degrees of success in understanding similar mechanisms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Below 18 years of age 2. Inability to consent to their own participation 3. Ongoing infection or severe illness where the study physician deems participation in the study not to be in the individuals best interest 4. Inability to read and understand Swedish, and therefore unable to complete the forms and questionnaires included in the project
Where this trial is running
Stockholm
- Centrum för reumatologi — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Albin Björk, MD, PhD
- Email: albin.bjork@ki.se
- Phone: +46 8-123 687 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.