Prognostic Value of Anti-Ro52 Antibodies in Connective Tissue Diseases (a-Ro52)
a-Ro52
Phenotypic Features and Prognostic Value of Anti-Ro52 (TRIM-21) Antibodies in Connective Tissue Diseases
1 other identifier
observational
400
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedDecember 9, 2019
November 1, 2019
1.7 years
June 5, 2018
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
ILD prevalence
Clinical (cough, dyspnea) and/or radiological (tomodensitometry) data
baseline (J0)
Secondary Outcomes (3)
ILD severity
baseline (J0)
Vasculopathy occurence
baseline (J0) and follow-up
Cancer occurence
baseline (J0) and follow-up
Study Arms (2)
CTD patients with anti-Ro52 antibodies
Connective tissue disease patients with anti-Ro52 antibodies at diagnosis
CTD patients without anti-Ro52 antibodies
Connective tissue disease patients without anti-Ro52 antibodies at diagnosis
Interventions
Clinical data, radiological data and laboratory tests follow-up
Eligibility Criteria
Patients with connective tissue disease (differenciated or not) and anti-Ro52 antibodies (as single specificity or associated with other autoantibody specificities) at diagnosis
You may qualify if:
- Connective tissue disease (differenciated or not)
- Presence of anti-Ro52 antibodies at diagnosis
You may not qualify if:
- Healthy subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Central Hospital
Dijon, France
Central Hospital
Lille, France
Private Hospital
Metz, France
Central Hospital
Nancy, France
Related Publications (7)
Ghillani P, Andre C, Toly C, Rouquette AM, Bengoufa D, Nicaise P, Goulvestre C, Gleizes A, Dragon-Durey MA, Alyanakian MA, Chretien P, Chollet-Martin S, Musset L, Weill B, Johanet C. Clinical significance of anti-Ro52 (TRIM21) antibodies non-associated with anti-SSA 60kDa antibodies: results of a multicentric study. Autoimmun Rev. 2011 Jul;10(9):509-13. doi: 10.1016/j.autrev.2011.03.004. Epub 2011 Apr 5.
PMID: 21447407BACKGROUNDLee 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.
PMID: 28417151BACKGROUNDHudson 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.
PMID: 22394602BACKGROUNDGunnarsson 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.
PMID: 26320136BACKGROUNDMurng 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.
PMID: 28663326BACKGROUNDReiseter 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.
PMID: 28379478BACKGROUNDBauhammer 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.
PMID: 27252419BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roland JAUSSAUD, Pr
Central Hospital, Nancy, France
- STUDY DIRECTOR
Paul DECKER, MR
Central Hospital, Nancy, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2018
First Posted
June 21, 2018
Study Start
January 1, 2019
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
December 9, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share