Identification of Genomic Biomarkers for Rheumatoid Arthritis With Late Onset

NCT05808309 | Withdrawn

• 1 other identifier: 2022/0023
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rheumatoid arthritis (RA) is a disabling disease leading to joint and bones destruction. This autoimmune disease is multifactorial, and some genetic and environmental risk factors are already described. However, a part of heritability is still unknown. Previous genomics studies dedicated to deciphering this missing heritability did not pay attention to age of onset. The purpose of this protocol is to determine genomic markers which are specific of RA with an age of onset above 65 years old. Indeed, clinical presentation, treatment tolerance and efficiency, and frequent comorbidities of this phenotype are particular. This signature of genomic biomarkers will be integrated in known molecular pathways to highlight specificities, helpful for biological targets identification.

Conditions

Rheumatoid Arthritis

Keywords

Late onset rheumatoid arthritis; Genomic biomarkers; Whole genome sequences; RNAseq; Proteome; Methylome

Outcome Measures

Primary Outcomes (2)

• Genomic signature for late onset rheumatoid arthritis

  Genomic DNA analysis

  at day 0

• Gene expression for late onset rheumatoid arthritis

  RNA analysis

  at day 0

Secondary Outcomes (2)

• Methylome for late onset rheumatoid arthritis

  at day 0

• Proteome for late onset rheumatoid arthritis

  at day 0

Study Arms (4)

PRp

Patients with a diagnostic of rheumatoid arthritis with an age of onset before 60 years

Other: Salivary sampling

PRt

Patients with a diagnostic of rheumatoid arthritis with an age of onset from 65 years

Other: Salivary sampling

Tem

Patients with a diagnostic of osteoarthritis without RA

Other: Salivary sampling

Ap

Relatives to PRt, with RA (with any age of onset) or without RA

Other: Salivary sampling

Interventions

Salivary sampling OTHER

Salivary sampling for genomic material (DNA and RNA (for primary outcome measures); proteins and DNA methylation (for secondary outcome measures)

Ap; PRp; PRt; Tem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed by the rheumatology service of CHSF

You may qualify if:

• patient with RA diagnosed before 60 years (PRp group)
• patient with RA diagnosed from 65 years (PRt group)
• patient without RA followed for osteoarthritis matched with patient of PRt according to age (+/- 1 year) and sex (Tem group).
• relative of patient PRt, without RA or with RA, regardless of age of onset (Ap group)
• patient who agreed to participate in the study and signed an informed consent

You may not qualify if:

• other inflammatory and/or autoimmune known disease for patients of PRp and PRt groups
• first symptoms of osteoarthritis before 40 years, other known inflammatory disease, other known autoimmune disease for Tem group.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Elisabeth PETIT-TEIXEIRA

  Laboratoire GenHotel Université d'Evry Val d'Essonne

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: May 28, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share