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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2016-A01851-50 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index/Eular Sjogren's Syndrome Patient Reported Index).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with primary Sjögren's syndrome | Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA) in patients with primary Sjögren's syndrome according to the American-European Consensus Criteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Other | Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA). |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of anti-Ro/SSA IgE positive patients | Comparison of proportion of anti-Ro/SSA IgE positive patients between patients with active pSS and patient without active pSS anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Active pSS is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI) ≥ 5 | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between anti-Ro/SSA IgE titers and pSS's activity. | pSS's activity is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI). Anti-Ro/SSA IgE titers is measured by serial dilutions of the serum. Anti-Ro/SSA IgE titers is the last dilution whose absorbance (in optical density) is higher than positivity threshold. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with primary Sjögren's syndrome
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascal CATHEBRAS, MD PhD | Contact | (0)477828342 | +33 | pascal.cathebras@chu-st-etienne.fr |
| Florence RANCON, CRA | Contact | (0)477120284 | +33 | florence.rancon@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pascal CATHEBRAS, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Pierre Oudot | Not yet recruiting | Bourgoin | 38300 | France |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples
| Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level | Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). The symptomatology level is measured by the Score Eular Sjogren's Syndrome Patient Reported Index (ESSPRI). If ESSPRI≥5: symptomatology whose intensity felt by the patient is not acceptable. If ESSPRI<5: symptomatology whose intensity felt by the patient is acceptable. | Day 1 |
| Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma | Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). There is a medical monitoring every years by medical record and/or by phone know that a development of lymphoma. | 5 years |
| Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature | Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Interferon alpha signature level is measured by real-time Polymerase Chain Reaction (PCR). They calculate the average of delta cycle threshold in messenger ribonucleic acid (mRNA) of regulate gene by interferon alpha. | Day 1 |
| Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics | Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Composite outcome of clinical and biologic characteristics is describe below. Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test. Biologic characteristics: anti-Ro/SSA IgE titers, rheumatoid factor titers and number of totals lymphocytes and T cluster of differentiation 4 (CD4) lymphocytes. | Day 1 |
| Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics | Anti-La/SSB IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Composite outcome of clinical and biologic characteristics is describe below. Clinical characteristics: type of affected organs, lymphoma medical history, allergic disorders, scores Eular Sjögren Syndrome Disease Activity Index (ESSDAI), Eular Sjogren's Syndrome Patient Reported Index (ESSPRI) and analogue visual scale disease patient and doctor, saliva flow and Schirmer test. Biologic characteristics: anti-La/SSB IgE titers, rheumatoid factor titers and number of totals lymphocytes and T CD4 lymphocytes. | Day 1 |
| CHU Estaing - Clermont Ferrand | Recruiting | Clermont-Ferrand | 63000 | France |
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| CHU Grenoble Alpes | Recruiting | Grenoble | 38700 | France |
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| Hôpital de la Croix Rousse | Recruiting | Lyon | 69317 | France |
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| CH Lyon Sud | Recruiting | Lyon | 69495 | France |
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| Hôpital Edouard Herriot - CHU Lyon | Not yet recruiting | Lyon | France |
|
| CHU Reims | Not yet recruiting | Reims | France |
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| Chu Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
|
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |