Rheumatoid ArthritisBIOGENOPRATNCT05808309
Identification of Genomic Biomarkers for Rheumatoid Arthritis With Late Onset
An observational study of Rheumatoid Arthritis, run by Centre Hospitalier Sud Francilien.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Salivary sampling
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2025to 1 Jan 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients followed by the rheumatology service of CHSF
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the detailed description
The purpose of this protocol is to identify a genomic signature specific of late onset RA and to contribute to the characterization of dedicated therapeutic targets. Collection of patients will be held at the rheumatology service of CHSF (Corbeil-Essonnes, France) and salivary samples will be collected for further genomic analyses conducted by GenHotel lab (Univ Evry - Univ Paris-Saclay, Evry, France).
First, analysis of whole genome/DNA sequences will allow to identify specific variants of late onset RA. Such identified biomarkers would help differential diagnosis and contribute to earlier initiation of care for RA relatives at risk of developing RA. Second, analysis of RNA sequences, including coding protein genes and non-coding RNA, will give information about gene expression and regulation, and molecular pathways. Comparison of patient groups will allow discrimination of biomarkers and molecular signature specific to the disease and to its onset phenotypes. Integration of such genomic data in the RA disease map (consisted of a network of biological pathways), and further modeling approaches, will highlight late onset RA particularities on which research of therapeutic target could be focused on.
To complete genomic analysis, methylome and proteome data will be produced in a second phase. Such data will help in identification of regulation process leading to a protein profile specific of late onset RA.
An ancillary study is planned from familial samples identified after analysis of data collected from RA patients. Risk genetic markers identification is facilitated in a familial context of analyses. Furthermore, non RA individuals in familial sample provide a control sample allowing better discrimination between family-dependent and phenotype-dependent genomic markers
- Conditions
- Rheumatoid Arthritis
- Being tested
- Salivary sampling
- Keywords
- Late onset rheumatoid arthritis, Genomic biomarkers, Whole genome sequences, RNAseq, Proteome, Methylome
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary samplingOther
Salivary sampling for genomic material (DNA and RNA (for primary outcome measures); proteins and DNA methylation (for secondary outcome measures)
| Study group | Role | What they receive |
|---|---|---|
| PRp | Patients with a diagnostic of rheumatoid arthritis with an age of onset before 60 years Receives: Other: Salivary sampling | |
| PRt | Patients with a diagnostic of rheumatoid arthritis with an age of onset from 65 years Receives: Other: Salivary sampling | |
| Tem | Patients with a diagnostic of osteoarthritis without RA Receives: Other: Salivary sampling | |
| Ap | Relatives to PRt, with RA (with any age of onset) or without RA Receives: Other: Salivary sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic signature for late onset rheumatoid arthritis
Genomic DNA analysis
Measured: at day 0
Gene expression for late onset rheumatoid arthritis
RNA analysis
Measured: at day 0
Secondary outcomes (2)
Methylome for late onset rheumatoid arthritis
DNA methylation profile
Measured: at day 0
Proteome for late onset rheumatoid arthritis
Protein profile
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start28 May 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth PETIT-TEIXEIRA, Study director, Laboratoire GenHotel Université d'Evry Val d'Essonne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808309
- Sponsor's protocol ID
- 2022/0023
- Acronym
- BIOGENOPRAT
- Status last verified
- Aug 2025
- First submitted
- 29 Mar 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genomic Biomarkers for Rheumatoid Arthritis With Late Onset
- ClinicalTrials.gov ID
- NCT05808309
- Acronym / sponsor ID
- BIOGENOPRAT / 2022/0023
- Conditions
- Rheumatoid Arthritis
- Keywords
- Late onset rheumatoid arthritis, Genomic biomarkers, Whole genome sequences, RNAseq, Proteome, Methylome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 28 May 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this protocol is to identify a genomic signature specific of late onset RA and to contribute to the characterization of dedicated therapeutic targets. Collection of patients will be held at the rheumatology service of CHSF (Corbeil-Essonnes, France) and salivary samples will be collected for further genomic analyses conducted by GenHotel lab (Univ Evry - Univ Paris-Saclay, Evry, France).
First, analysis of whole genome/DNA sequences will allow to identify specific variants of late onset RA. Such identified biomarkers would help differential diagnosis and contribute to earlier initiation of care for RA relatives at risk of developing RA. Second, analysis of RNA sequences, including coding protein genes and non-coding RNA, will give information about gene expression and regulation, and molecular pathways. Comparison of patient groups will allow discrimination of biomarkers and molecular signature specific to the disease and to its onset phenotypes. Integration of such genomic data in the RA disease map (consisted of a network of biological pathways), and further modeling approaches, will highlight late onset RA particularities on which research of therapeutic target could be focused on.
To complete genomic analysis, methylome and proteome data will be produced in a second phase. Such data will help in identification of regulation process leading to a protein profile specific of late onset RA.
An ancillary study is planned from familial samples identified after analysis of data collected from RA patients. Risk genetic markers identification is facilitated in a familial context of analyses. Furthermore, non RA individuals in familial sample provide a control sample allowing better discrimination between family-dependent and phenotype-dependent genomic markers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRp | – | Other: Salivary samplingPatients with a diagnostic of rheumatoid arthritis with an age of onset before 60 years |
| PRt | – | Other: Salivary samplingPatients with a diagnostic of rheumatoid arthritis with an age of onset from 65 years |
| Tem | – | Other: Salivary samplingPatients with a diagnostic of osteoarthritis without RA |
| Ap | – | Other: Salivary samplingRelatives to PRt, with RA (with any age of onset) or without RA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed by the rheumatology service of CHSF
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary samplingSalivary sampling for genomic material (DNA and RNA (for primary outcome measures); proteins and DNA methylation (for secondary outcome measures) | Other | Ap, PRp, PRt, Tem |
Primary outcome
Genomic signature for late onset rheumatoid arthritis
Time frame: at day 0
Genomic DNA analysis
Gene expression for late onset rheumatoid arthritis
Time frame: at day 0
RNA analysis
2 secondary outcomes
Methylome for late onset rheumatoid arthritis
Time frame: at day 0
Proteome for late onset rheumatoid arthritis
Time frame: at day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth PETIT-TEIXEIRA study director
Laboratoire GenHotel Université d'Evry Val d'Essonne
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Centre Hospitalier Sud Francilien.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic signature for late onset rheumatoid arthritis (time frame: at day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.