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

Connective Tissue Diseases Clinical Trial

— a-Ro52  

Official title:

Phenotypic Features and Prognostic Value of Anti-Ro52 (TRIM-21) Antibodies in Connective Tissue Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03565601
• Other study ID #: PSS2018/AR052-DECKER/MS
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2019
• Source: Central Hospital, Nancy, France
• Contact: Roland JAUSSAUD, Pr
• Phone: 0383154067
• Email: R.JAUSSAUD[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Connective tissue disease (differenciated or not)

• Presence of anti-Ro52 antibodies at diagnosis

Exclusion Criteria:

• Healthy subjects

Related Conditions & MeSH terms

• Connective Tissue Diseases

Intervention

Other:
• Follow-up
Clinical data, radiological data and laboratory tests follow-up

Locations

Country	Name	City	State
France	Central Hospital	Dijon
France	Central Hospital	Lille
France	Private Hospital	Metz
France	Central Hospital	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

Ghillani P, André 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. — View Citation

Gunnarsson R, El-Hage F, Aaløkken TM, Reiseter S, Lund MB, Garen T; Norwegian MCTD study group, Molberg Ø. 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. — View 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. — View 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. Review. — View 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. — View Citation

Reiseter S, Gunnarsson R, Mogens Aaløkken T, Lund MB, Mynarek G, Corander J, Haydon J, Molberg Ø. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ILD prevalence	Clinical (cough, dyspnea) and/or radiological (tomodensitometry) data	baseline (J0)
Secondary	ILD severity	PFT (pulmonary function test): FVC, FEV1, DLCO (percentages of predicted values)	baseline (J0)
Secondary	Vasculopathy occurence	Raynaud disease, digital ulcers or gangrene	baseline (J0) and follow-up
Secondary	Cancer occurence		baseline (J0) and follow-up