Evaluating a Biomarker for Disease Activity in Primary Sjögren's Syndrome
Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
This study is testing if measuring a specific type of antibody in the blood can help doctors understand how active the disease is in people with Primary Sjögren's Syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 185 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Drugs / interventions | sifalimumab, rontalizumab, anifrolumab, belimumab |
| Locations | 8 sites (Bourgoin and 7 other locations) |
| Trial ID | NCT03003572 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the presence of autoreactive anti-Ro/SSA immunoglobulin E (IgE) as a potential biomarker for disease activity in patients with Primary Sjögren's Syndrome (pSS). It will include consecutive patients diagnosed with pSS, either newly diagnosed or previously known, and will measure the levels of anti-Ro/SSA IgE in their blood samples. The study will determine if higher levels of this biomarker correlate with active disease, as defined by the EULAR Sjögren Syndrome Disease Activity Index. The findings could enhance the understanding of disease activity and improve patient management.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Primary Sjögren's Syndrome according to established criteria.
Not a fit: Patients with secondary Sjögren's syndrome or other systemic autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable biomarker for monitoring disease activity in patients with Primary Sjögren's Syndrome.
How similar studies have performed: While the specific approach of using anti-Ro/SSA IgE as a biomarker is novel, similar studies have explored biomarkers in autoimmune diseases with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary Sjögren's syndrome according to the American-European Consensus Criteria) * Informed and having signed the study consent form Exclusion Criteria: * Secondary Sjögren's syndrome * Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…) * Incapacity or refusal to sign the informed consent form * Incapacity or refusal to perform the follow-up examinations required by the study * Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion * Has any current signs or symptoms of active infection
Where this trial is running
Bourgoin and 7 other locations
- CH Pierre Oudot — Bourgoin, France (Not_yet_recruiting)
- CHU Estaing - Clermont Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU Grenoble Alpes — Grenoble, France (Recruiting)
- Hôpital de la Croix Rousse — Lyon, France (Recruiting)
- CH Lyon Sud — Lyon, France (Recruiting)
- Hôpital Edouard Herriot - CHU Lyon — Lyon, France (Not_yet_recruiting)
- CHU Reims — Reims, France (Not_yet_recruiting)
- Chu Saint-Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Pascal CATHEBRAS, MD PhD — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Pascal CATHEBRAS, MD PhD
- Email: pascal.cathebras@chu-st-etienne.fr
- Phone: (0)477828342
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.