Clinical trial NCT03565601: Prognostic Value of Anti-Ro52 Antibodies in Connective Tissue Diseases (a-Ro52)
Official title: Phenotypic Features and Prognostic Value of Anti-Ro52 (TRIM-21) Antibodies in Connective Tissue Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Connective Tissue Diseases
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with connective tissue disease (differenciated or not) and anti-Ro52 antibodies (as single specificity or associated with other autoantibody specificities) at diagnosis

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 and vasculopathy prevalence and severity, cancers occurence and others clinical features of connective tissue disease patients with anti-Ro52 autoantibodies.


Eligibility criteria: Inclusion Criteria:

* Connective tissue disease (differenciated or not)
* Presence of anti-Ro52 antibodies at diagnosis

Exclusion Criteria:

* Healthy subjects

Primary outcomes:
measure: ILD prevalence
timeFrame: baseline (J0)
Secondary outcomes:
measure: ILD severity
timeFrame: baseline (J0)
measure: Vasculopathy occurence
timeFrame: baseline (J0) and follow-up
measure: Cancer occurence
timeFrame: baseline (J0) and follow-up
Other outcomes:
Locations:
city: Dijon
country: France
facility: Central Hospital
city: Lille
country: France
facility: Central Hospital
city: Metz
country: France
facility: Private Hospital
city: Nancy
country: France
facility: Central Hospital
Study officials:
affiliation: Central Hospital, Nancy, France
name: Roland JAUSSAUD, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Paul DECKER, MR
role: STUDY_DIRECTOR
References:
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citation: Lee AYS. A review of the role and clinical utility of anti-Ro52/TRIM21 in systemic autoimmunity. Rheumatol Int. 2017 Aug;37(8):1323-1333. doi: 10.1007/s00296-017-3718-1. Epub 2017 Apr 17.
citation: Hudson M, Pope J, Mahler M, Tatibouet S, Steele R, Baron M; Canadian Scleroderma Research Group (CSRG); Fritzler MJ. Clinical significance of antibodies to Ro52/TRIM21 in systemic sclerosis. Arthritis Res Ther. 2012 Mar 6;14(2):R50. doi: 10.1186/ar3763.
citation: Gunnarsson R, El-Hage F, Aalokken TM, Reiseter S, Lund MB, Garen T; Norwegian MCTD study group; Molberg O. Associations between anti-Ro52 antibodies and lung fibrosis in mixed connective tissue disease. Rheumatology (Oxford). 2016 Jan;55(1):103-8. doi: 10.1093/rheumatology/kev300. Epub 2015 Aug 28.
citation: Murng SHK, Thomas M. Clinical associations of the positive anti Ro52 without Ro60 autoantibodies: undifferentiated connective tissue diseases. J Clin Pathol. 2018 Jan;71(1):12-19. doi: 10.1136/jclinpath-2015-203587. Epub 2017 Jun 29.
citation: Reiseter S, Gunnarsson R, Mogens Aalokken T, Lund MB, Mynarek G, Corander J, Haydon J, Molberg O. Progression and mortality of interstitial lung disease in mixed connective tissue disease: a long-term observational nationwide cohort study. Rheumatology (Oxford). 2018 Feb 1;57(2):255-262. doi: 10.1093/rheumatology/kex077.
citation: Bauhammer J, Blank N, Max R, Lorenz HM, Wagner U, Krause D, Fiehn C. Rituximab in the Treatment of Jo1 Antibody-associated Antisynthetase Syndrome: Anti-Ro52 Positivity as a Marker for Severity and Treatment Response. J Rheumatol. 2016 Aug;43(8):1566-74. doi: 10.3899/jrheum.150844. Epub 2016 Jun 1.