Systemic SclerosisNCT06029335
Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases
An observational study of Systemic Sclerosis and Systemic Lupus Erythematosus, run by University of Pecs at 1 site in Hungary.
Trial summary
Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis, Systemic Lupus Erythematosus, Myopathies, Inflammatory
- How many people
- 400 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2020to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Consecutive patients were enrolled into the study originating from the Rheumatology and Immunology Department, Medical School, University of Pécs. Control healthy groups including consecutive sex and age-matched healthy individuals are invited to participate.
Who may be able to join
- Systemic autoimmune diseases
- Healthy individuals - as controls
Who cannot join
- Diseases of the central nervous system
- Presence of pregnancy
Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Pécs, Department of Rheumatology and Immunology
Pécs, 7632
About this study
Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. However, these symptoms significantly impact patients' routines and quality of life. The study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases.
Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF, Galectin-3, and Pentraxin as well as results of functional, quality of life, and neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.
- Conditions
- Systemic Sclerosis, Systemic Lupus Erythematosus, Myopathies, Inflammatory, Rheumatoid Arthritis, Healthy
- Medical subject headings
- Scleroderma, Systemic, Lupus Erythematosus, Systemic, Myositis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diffuse cutaneous Systemic sclerosis | Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Limited cutaneous Systemic sclerosis | Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Primary Raynaud's | Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Healthy | Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Rheumatoid arthritis | Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Inflammatory myopathies | Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. | |
| Systemic lupus erythematosus | Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-mental State Examination
Complex Cognitive measure
Measured: 12 months
The Functional Assessment of Chronic Illness Therapy F
health-related quality of life measure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Sep 2020
- Primary completion10 Oct 2022
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr Varjú Cecília, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029335
- Sponsor's protocol ID
- 35147-3/2020/ EÜIG
- Other IDs
- 05570-6/2023
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are not publicly available due to ethical issues.
Publications
Olah C, Schwartz N, Denton C, Kardos Z, Putterman C, Szekanecz Z. Cognitive dysfunction in autoimmune rheumatic diseases. Arthritis Res Ther. 2020 Apr 15;22(1):78. doi: 10.1186/s13075-020-02180-5.
PubMed 32293528Krampek L, Kiss F, Farkas N, Faludi R, Nagy G, Szabo A, Czirjak L, Varju C. Risk factors of cognitive function impairment in patients with systemic sclerosis. Clin Exp Rheumatol. 2025 Aug;43(8):1481-1491. doi: 10.55563/clinexprheumatol/isx6h8. Epub 2025 Aug 1.
PubMed 40757427
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06029335
- Acronym / sponsor ID
- 35147-3/2020/ EÜIG
- Conditions
- Systemic Sclerosis, Systemic Lupus Erythematosus, Myopathies, Inflammatory, Rheumatoid Arthritis, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 8 Sep 2023 (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.
Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. However, these symptoms significantly impact patients' routines and quality of life. The study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases.
Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF, Galectin-3, and Pentraxin as well as results of functional, quality of life, and neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Diffuse cutaneous Systemic sclerosis | – | –Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. |
| Limited cutaneous Systemic sclerosis | – | –Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. |
| Primary Raynaud's | – | –Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. |
| Healthy | – | –Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. |
| Rheumatoid arthritis | – | –Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. |
| Inflammatory myopathies | – | –Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. |
| Systemic lupus erythematosus | – | –Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients were enrolled into the study originating from the Rheumatology and Immunology Department, Medical School, University of Pécs. Control healthy groups including consecutive sex and age-matched healthy individuals are invited to participate.
Key inclusion criteria (2 listed)
- Systemic autoimmune diseases
- Healthy individuals - as controls
Key exclusion criteria (2 listed)
- Diseases of the central nervous system
- Presence of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini-mental State Examination
Time frame: 12 months
Complex Cognitive measure
The Functional Assessment of Chronic Illness Therapy F
Time frame: 12 months
health-related quality of life measure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 32293528Olah C, Schwartz N, Denton C, Kardos Z, Putterman C, Szekanecz Z. Cognitive dysfunction in autoimmune rheumatic diseases. Arthritis Res Ther. 2020 Apr 15;22(1):78. doi: 10.1186/s13075-020-02180-5.
- Derived from this study: PubMed 40757427Krampek L, Kiss F, Farkas N, Faludi R, Nagy G, Szabo A, Czirjak L, Varju C. Risk factors of cognitive function impairment in patients with systemic sclerosis. Clin Exp Rheumatol. 2025 Aug;43(8):1481-1491. doi: 10.55563/clinexprheumatol/isx6h8. Epub 2025 Aug 1.
- Individual participant dataSharing planned: No. Data are not publicly available due to ethical issues.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Systemic Sclerosis and Systemic Lupus Erythematosus, run by University of Pecs at 1 site in Hungary.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-mental State Examination (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06029335, which also lists 2 linked publications.
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 11 Sep 2023.