NCT05394922 Glycosylation Analysis of Lupus Anti-DNA Antibodies (GALA)
| NCT ID | NCT05394922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Lupus Erythematosus Disseminatus |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-08-23 |
| Primary Completion | 2026-02-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2022-08-23 with a primary completion date of 2026-02-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Systemic lupus erythematosus (SLE) is a severe autoimmune disease in which patients often develop numerous autoantibodies (Abs). Unfortunately, none of the SLE specific Abs described so far (anti-DNA, -C1q, -nucleosome) are correlated enough to the disease activity to be used as a useful biomarker and reliably help in the therapeutic decision. Abs effector functions, including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP) and antibody-mediated complement activation, are conditioned by the structure of the crystallizable fragment (Fc) and especially the N-linked oligosaccharide structures attached to the asparagine-297 in the CH2 domain of the Fc region. It has been shown that the decrease in galactosylation, sialylation and fucolylation is generally associated with inflammatory function of circulating IgG whereas Abs with sialic acid, fucose and/or galactose in Asn-297 are anti-inflammatory. This major role of Ab glycosylation in the regulation of the effector and pathogenic functions of Abs have been well documented in rheumatoid arthritis and ANCA associated vasculitis with a good correlation between Ab sialylation and disease activity. In lupus, it has been shown that glycosylation of total IgG is also altered and correlated with disease activity but glycosylation analysis of the LES specific Abs is still lacking. The aim of this study is to analyse by mass spectrometry (MS) the different glycoforms of anti-DNA Abs in lupus patients and find a correlation with disease activity.
Eligibility Criteria
Inclusion Criteria: * Patients presenting with LED according to the ACR/EULAR 2019 criteria, all clinical forms combined, quiescent or in flare with positive native anti-DNA antibodies, providing oral informed consent. Exclusion Criteria: * Patients under protection of justice or unable to receive a clear information. * High probability of non-compliance with the protocol or withdrawal during the study * Already involved in another interventional clinical study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05394922 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lupus Erythematosus Disseminatus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05394922 currently recruiting?
Yes, NCT05394922 is actively recruiting participants. Contact the research team at t-vincent@chu-montpellier.fr for enrollment information.
Where is the NCT05394922 trial being conducted?
This trial is being conducted at Montpellier, France, Nîmes, France.
Who is sponsoring the NCT05394922 clinical trial?
NCT05394922 is sponsored by University Hospital, Montpellier. The trial plans to enroll 140 participants.
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