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

NCT ID: NCT03565601

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Connective Tissue Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CTD patients with anti-Ro52 antibodies

Connective tissue disease patients with anti-Ro52 antibodies at diagnosis

Follow-up

Intervention Type OTHER

Clinical data, radiological data and laboratory tests follow-up

CTD patients without anti-Ro52 antibodies

Connective tissue disease patients without anti-Ro52 antibodies at diagnosis

Follow-up

Intervention Type OTHER

Clinical data, radiological data and laboratory tests follow-up

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Follow-up

Clinical data, radiological data and laboratory tests follow-up

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Healthy subjects
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roland JAUSSAUD, Pr

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Paul DECKER, MR

Role: STUDY_DIRECTOR

Central Hospital, Nancy, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Central Hospital

Dijon, , France

Site Status COMPLETED

Central Hospital

Lille, , France

Site Status COMPLETED

Private Hospital

Metz, , France

Site Status RECRUITING

Central Hospital

Nancy, , France

Site Status COMPLETED

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Roland JAUSSAUD, Pr

Role: CONTACT

Phone: 0383154067

Email: [email protected]

Paul DECKER, MR

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

François MAURIER, Dr

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21447407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28417151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22394602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26320136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28663326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28379478 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27252419 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PSS2018/AR052-DECKER/MS

Identifier Type: -

Identifier Source: org_study_id