Analysis of glycosylation in lupus anti-DNA antibodies
Glycosylation Analysis of Anti-DNA Auto-antibodies as Biomarker in the Follow up of Patients With Lupus Erythematosus Disseminated (GALA)
This study looks at how certain sugars on antibodies in people with lupus might change over time and how those changes relate to their disease activity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT05394922 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the glycosylation patterns of anti-DNA antibodies in patients with systemic lupus erythematosus (SLE). A total of 140 adult patients will be recruited from the University Hospital of Montpellier and Nîmes, and followed for one year. Blood samples will be collected at the start, after one year, and during any disease flare, with serum stored for analysis. The glycosylation status of the antibodies will be determined using mass spectrometry and correlated with disease activity measured by the SLEDAI score.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with systemic lupus erythematosus who have positive native anti-DNA antibodies.
Not a fit: Patients who are unable to provide informed consent or are involved in other interventional studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved biomarkers for monitoring disease activity in lupus patients.
How similar studies have performed: While glycosylation analysis in antibodies is a recognized area of research, this specific approach in lupus has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier and 1 other locations
- Montpellier University Hospital — Montpellier, France (Recruiting)
- Nimes University Hospital — Nîmes, France (Recruiting)
Study contacts
- Study coordinator: Thierry VINCENT, MD
- Email: t-vincent@chu-montpellier.fr
- Phone: +334 67 33 71 35
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.