Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity (I GET DRY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03003572
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
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).

Condition or disease Intervention/treatment
Primary Sjögren's Syndrome Other: Blood samples

Layout table for study information
Study Type : Observational
Estimated Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Blood samples
Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).




Primary Outcome Measures :
  1. Proportion of anti-Ro/SSA IgE positive patients [ Time Frame: Day 1 ]

    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



Secondary Outcome Measures :
  1. Correlation between anti-Ro/SSA IgE titers and pSS's activity. [ Time Frame: Day 1 ]

    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.


  2. Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level [ Time Frame: Day 1 ]

    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.


  3. Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma [ Time Frame: 5 years ]

    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.


  4. Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature [ Time Frame: Day 1 ]

    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.


  5. Comparison between anti-Ro/SSA IgE positive patients and clinical and biologic characteristics [ Time Frame: Day 1 ]

    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.


  6. Comparison between anti-La/SSB IgE positive patients and clinical and biologic characteristics [ Time Frame: Day 1 ]

    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.



Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary Sjögren's syndrome
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003572


Contacts
Layout table for location contacts
Contact: Pascal CATHEBRAS, MD PhD (0)477828342 ext +33 pascal.cathebras@chu-st-etienne.fr
Contact: Florence RANCON, CRA (0)477120284 ext +33 florence.rancon@chu-st-etienne.fr

Locations
Layout table for location information
France
CH Pierre Oudot Not yet recruiting
Bourgoin-Jallieu, France, 38300
Contact: Marielle ROUX, MD         
Principal Investigator: Marielle ROUX, MD         
CHU Estaing - Clermont Ferrand Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: Marc RUIVARD, MD PhD         
Principal Investigator: Marc RUIVARD, MD PhD         
Sub-Investigator: Virginie RIEU, MD         
Sub-Investigator: Vincent GROBOST, MD         
CHU Grenoble Alpes Recruiting
Grenoble, France, 38700
Contact: Laurence BOULLET, MD PhD         
Principal Investigator: Laurence BOUILLET, MD PhD         
Sub-Investigator: Françoise SARROT-REYNAULD, MD         
Sub-Investigator: Alban DEROUX, MD         
Sub-Investigator: Alexis BOCQUET, MD         
Hôpital de la Croix Rousse Recruiting
Lyon, France, 69317
Contact: Pascal SEVE, MD         
Principal Investigator: Pascal SEVE, MD         
Sub-Investigator: Yvan JAMILLOUX, MD         
Sub-Investigator: Mathieu GERFAUD-VALENTIN, MD         
Sub-Investigator: Claire BERNARD, MD         
Sub-Investigator: Mathilde FRANÇOIS, MD         
CH Lyon Sud Recruiting
Lyon, France, 69495
Contact: Jean-Christophe LEGA, MD         
Principal Investigator: Jean-Christophe LEGA, MD         
Sub-Investigator: Quitterie REYNAUD, MD         
Sub-Investigator: Isabelle DURIEU, MD         
Sub-Investigator: Sabine MAINBOURG, MD         
Hôpital Edouard Herriot - CHU Lyon Not yet recruiting
Lyon, France
Contact: Arnaud HOT, MD PhD         
Principal Investigator: Arnaud HOT, MD PhD         
Sub-Investigator: Cécile-Audrey DUREL, MD         
Chu Saint-Etienne Recruiting
Saint Etienne, France, 42055
Contact: Pascal CATHEBRAS, MD PhD         
Principal Investigator: Pascal CATHEBRAS, MD PhD         
Sub-Investigator: Isabelle GUICHARD, MD         
Sub-Investigator: Jean-Baptiste GAULTIER, MD         
Sub-Investigator: Anne-Emmanuelle DEPINCE-BERGER, MD         
Sub-Investigator: Thierry THOMAS, MD PhD         
Sub-Investigator: Hubert MAROTTE, MD PhD         
Sub-Investigator: Héloïse MUNOZ-PONS, MD         
Sub-Investigator: Martin KILLIAN, MD         
Sub-Investigator: Béatrice PALLOT-PRADES, MD         
Sub-Investigator: Karima BOUSSOUALIM, MD         
Sub-Investigator: Mijola LAMBERT, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Layout table for investigator information
Principal Investigator: Pascal CATHEBRAS, MD PhD CHU SAINT-ETIENNE

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03003572     History of Changes
Other Study ID Numbers: 1608171
ANSM ( Other Identifier: 2016-A01851-50 )
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Sjögren's syndrome
Immunoglobulin E
Anti-Ro/SSA
Autoimmune disease
Biomarker
Additional relevant MeSH terms:
Layout table for MeSH terms
Xerostomia
Mouth Diseases
Dry Eye Syndromes
Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases