AutoantibodiesProgreSSNCT06594861
Follow-up Study of Individuals with Autoantibodies Against Ro/SSA and La/SSB
An observational study of Autoantibodies, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoantibodies
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 9 Feb 2024to Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Centrum för reumatologi
Stockholm
Albin Björk, MD, PhD, +46 8-123 687 04, albin.bjork@ki.se
About this study
Official title: Follow-up of Clinical Manifestations and Inflammation-related Parameters in Individuals with Autoantibodies Against Ro/SSA and La/SSB
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.
Read the 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:
- Clinically characterizing at-risk individuals who carry autoantibodies against Ro/SSA and/or La/SSB through medical consultations at a rheumatology specialist clinic.
- Immunologically characterizing at-risk individuals in comparison with healthy individuals through blood sampling and immunological analyses.
- 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.
- Conditions
- Autoantibodies
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with autoantibodies against Ro/SSA and/or La/SSB | Not described Receives: Other: No intervention | |
| Individuals without autoantibodies against Ro/SSA and/or La/SSB | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a rheumatic disease
The number of participants that develop rheumatic disease among the individuals with autoantibodies will be assessed
Measured: 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
Measured: From enrolment to a maximum of 9 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Feb 2024
- Primary completionDec 2038 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutoantibodiesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albin Björk, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594861
- Sponsor's protocol ID
- 2023-04569-01
- Other IDs
- 2023
- Acronym
- ProgreSS
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Clinical Manifestations and Inflammation-related Parameters in Individuals with Autoantibodies Against Ro/SSA and La/SSB
- ClinicalTrials.gov ID
- NCT06594861
- Acronym / sponsor ID
- ProgreSS / 2023-04569-01
- Conditions
- Autoantibodies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- Dec 2038 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Clinically characterizing at-risk individuals who carry autoantibodies against Ro/SSA and/or La/SSB through medical consultations at a rheumatology specialist clinic.
- Immunologically characterizing at-risk individuals in comparison with healthy individuals through blood sampling and immunological analyses.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- At least one instance of testing positive for Ro/SSA or La/SSB, regardless of the method used.
- Have no rheumatologic disease and no autoantibodies against Ro/SSA or La/SSB.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention. | Other | Individuals with autoantibodies against Ro/SSA and/or La/SSB, Individuals without autoantibodies against Ro/SSA and/or La/SSB |
Primary outcome
Development of a rheumatic disease
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
1 secondary outcome
Frequency of clinical symptoms
Time frame: From enrolment to a maximum of 9 years of follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoantibodies, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albin Björk, MD, PhD (+46 8-123 687 04, albin.bjork@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a rheumatic disease (time frame: From enrolment to a maximum of 9 years of follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.