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Prognostic Value of Anti-Ro52 Antibodies in Connective Tissue Diseases (a-Ro52) (a-Ro52)

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ClinicalTrials.gov Identifier: NCT03565601
Recruitment Status : Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:
Anti-Ro52 autoantibodies can be detected in patients with several autoimmune diseases. Clinical significance of anti-Ro52 is controversial. The presence of anti-Ro52 may be a factor associated with disease severity (interstitial lung disease, vasculopathy) and cancers. The aim of this study is to assess interstitial lung disease prevalence and severity, cancers occurence and others clinical features of connective tissue disease patients with anti-Ro52 autoantibodies.

Condition or disease Intervention/treatment
Connective Tissue Diseases Other: Follow-up

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Phenotypic Features and Prognostic Value of Anti-Ro52 (TRIM-21) Antibodies in Connective Tissue Diseases
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Connective tissue disease patients with anti-Ro52 Other: Follow-up
Clinical data, radiological data and laboratory tests follow-up




Primary Outcome Measures :
  1. ILD-GAP index [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Dyspnea [ Time Frame: baseline ]
    NYHA classification

  2. PFT (pulmonary function test) [ Time Frame: baseline ]
    FVC, FEV1, DLCO

  3. CT pattern [ Time Frame: baseline ]
    UIP, NSIP, HSP, unclassifiable ILD

  4. CT lesions extension [ Time Frame: baseline ]
  5. Cancer occurence [ Time Frame: baseline ]
  6. Relapse free survival [ Time Frame: baseline ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with connective tissue disease (differenciated or not) and anti-Ro52 autoantibodies (as single specificity or associated with other autoantibody specificities)
Criteria

Inclusion Criteria:

  • Connective tissue disease (differenciated or not)
  • Presence of anti-Ro52 antibodies (at least one time)

Exclusion Criteria:

  • Healthy subjects

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): NCT03565601


Contacts
Contact: Roland JAUSSAUD, Pr 0383154067 R.JAUSSAUD@chru-nancy.fr
Contact: Paul DECKER, MR decker.paul57130@gmail.com

Locations
France
Central Hospital Not yet recruiting
Dijon, France
Contact: Bernard BONNOTTE, Pr       bernard.bonnotte@chu-dijon.fr   
Principal Investigator: Bernard BONNOTTE, Pr         
Central Hospital Not yet recruiting
Lille, France
Contact: Eric Hachulla, Pr       eric.hachulla@chru-lille.fr   
Principal Investigator: Eric HACHULLA, Pr         
Private Hospital Not yet recruiting
Metz, France
Contact: François MAURIER, Dr       francois.maurier@hp-metz.fr   
Principal Investigator: François MAURIER, Dr         
Central Hospital Not yet recruiting
Nancy, France
Contact: Paul DECKER, MR       decker.paul57130@gmail.com   
Principal Investigator: Roland JAUSSAUD, Pr         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Roland JAUSSAUD, Pr Central Hospital, Nancy, France
Study Director: Paul DECKER, MR Central Hospital, Nancy, France

Publications:

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03565601     History of Changes
Other Study ID Numbers: PSS2018/AR052-DECKER/MS
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Connective Tissue Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs