RhA - Rheumatoid ArthritisRDNCT06386380
Adversity and Its Association With the Development and Expression of Rheumatic Diseases
An observational study of RhA - Rheumatoid Arthritis, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran.
Trial summary
Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- RhA - Rheumatoid Arthritis
- What is being tested?
- Rheumatic diseases Mistreatment Scale (RDMS), Routine assessment of patient index data 3 (RAPID-3) and Health Assessment Questionnaire (HAQ)
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Feb 2026
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Who may be able to join
- Patients with a rheumatoid arthritis diagnosis, according to their primary rheumatologist who agrees to participate
Who cannot join
- Patients with a not confirmed rheumatoid arthritis diagnosis
Trial locations and contacts
No sites are listed yet.
About this study
Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. In the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. Some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to DNA modification, and cellular senescence.
With this background, the investigators wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness.
Read the detailed description
To answer this question, the investigators proposed conducting a study on outpatients diagnosed with rheumatoid arthritis treated at the INCMNSZ.
Patients who agree to participate will be asked to answer some questionnaires to report their perception of child abuse and abuse derived from suffering from rheumatoid arthritis, disease activity, disability, quality of life, anxiety, stress, depression, and resilience.
Additionally, a peripheral blood sample will be taken to evaluate cellular senescence through CD27, CD28, and CD57 expression, the relative expression of the p16INK4a gene in CD3+ lymphocytes, HLA-DR, CD25, and CD69, and telomere length. Finally, the expression of the severity of the disease will be determined.
- Conditions
- RhA - Rheumatoid Arthritis
- Being tested
- Rheumatic diseases Mistreatment Scale (RDMS), Routine assessment of patient index data 3 (RAPID-3), Health Assessment Questionnaire (HAQ), WHOQOL-BREF, Depression, Anxiety and Stress Scale (DASS-21)
- Keywords
- Adversity, Rheumatic diseases
- Medical subject headings
- Arthritis, Rheumatoid, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheumatic diseases Mistreatment Scale (RDMS)Other
Also called RD-MS
In 2012, Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS); translation, cultural adaptation, and validation were performed prior to its application.
Routine assessment of patient index data 3 (RAPID-3)Other
Also called RAPID-3
RAPID- 3 measures: function, pain, and patient global status estimate. Each of the three individual measures is scored 0 to 10, for a total of 30
Health Assessment Questionnaire (HAQ)Other
Also called HAQ
The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality.
WHOQOL-BREFOther
WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items
Depression, Anxiety and Stress Scale (DASS-21)Other
Also called DASS-21
DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content.
Brief Resilient Coping ScaleOther
Also called BRCS
The Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner.
Expression of CDKN2A /p16INK4aGenetic
CDKN2A/p16INK4a expression will be measured using the Taqman qPCR assay (TaqMan Universal Master Mix II, with UNG, Applied Biosystems, Foster City, USA) according to the manufacturer's specifications.
Immunophenotype of leukocyte subpopulationsOther
CD4+ and CD8+ subpopulations will be analyzed. Blood samples will be analyzed by 8-color flow cytometry (Becton Dickinson Canto II cytometer) using fluorescently labeled antibodies from Biolegend Inc. (San Diego, USA).
Telomere lengthGenetic
The rLTL will be estimated by quantitative monochromatic multiplex PCR (MM-qPCR). Integrated DNA Technologies, Inc. (IDT, Coralville, IA, USA) will synthesize the primers used for telomere measurements.
Cellular senescenceOther
Expression of co-stimulatory molecules and surface receptors CD27- and CD28-
| Study group | Role | What they receive |
|---|---|---|
| Patients with rheumatoid arthritis | Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences Receives: Other: Rheumatic diseases Mistreatment Scale (RDMS); Other: Routine assessment of patient index data 3 (RAPID-3); Other: Health Assessment Questionnaire (HAQ); Other: WHOQOL-BREF; Other: Depression, Anxiety and Stress Scale (DASS-21); Other: Brief Resilient Coping Scale; Genetic: Expression of CDKN2A /p16INK4a; Other: Immunophenotype of leukocyte subpopulations; Genetic: Telomere length; Other: Cellular senescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adversity and senescence in patients with rheumatoid arthritis
To evaluate whether the presence of adversity (history of abuse in childhood and/or abuse associated with RD) is associated with markers of senescence in patients with rheumatoid arthritis.
Measured: At inclusion (baseline moment) (cross-sectional study)]
Secondary outcomes (2)
Eexpression of the p16INK4a gene in CD3+
Compare the relative expression of the p16INK4a gene in CD3+ lymphocytes between rheumatoid arthritis patients with and without adversity.
Measured: At inclusion (baseline moment) (cross-sectional study)]
Telomere length
Compare telomere length between RA patients with and without adversity.
Measured: At inclusion (baseline moment) (cross-sectional study)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhA - 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia Pascual Ramos, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Investigators
- Virginia MD Pascual-Ramos, MD, Principal investigator, IInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386380
- Sponsor's protocol ID
- IRE-4906
- Acronym
- RD
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baumer Y, Powell-Wiley TM. Interdisciplinary approaches are fundamental to decode the biology of adversity. Cell. 2021 May 27;184(11):2797-2801. doi: 10.1016/j.cell.2021.04.010.
PubMed 34048701
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adversity and Its Association With the Development and Expression of Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT06386380
- Acronym / sponsor ID
- RD / IRE-4906
- Conditions
- RhA - Rheumatoid Arthritis
- Keywords
- Adversity, Rheumatic diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 26 Apr 2024 (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.
Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. In the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. Some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to DNA modification, and cellular senescence.
With this background, the investigators wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness.
Detailed description
To answer this question, the investigators proposed conducting a study on outpatients diagnosed with rheumatoid arthritis treated at the INCMNSZ.
Patients who agree to participate will be asked to answer some questionnaires to report their perception of child abuse and abuse derived from suffering from rheumatoid arthritis, disease activity, disability, quality of life, anxiety, stress, depression, and resilience.
Additionally, a peripheral blood sample will be taken to evaluate cellular senescence through CD27, CD28, and CD57 expression, the relative expression of the p16INK4a gene in CD3+ lymphocytes, HLA-DR, CD25, and CD69, and telomere length. Finally, the expression of the severity of the disease will be determined.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatoid arthritis | – | Other: Rheumatic diseases Mistreatment Scale (RDMS), Other: Routine assessment of patient index data 3 (RAPID-3), Other: Health Assessment Questionnaire (HAQ), Other: WHOQOL-BREF, Other: Depression, Anxiety and Stress Scale (DASS-21), Other: Brief Resilient Coping Scale, Genetic: Expression of CDKN2A /p16INK4a, Other: Immunophenotype of leukocyte subpopulations, Genetic: Telomere length, Other: Cellular senescencePatients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Key inclusion criteria (1 listed)
- Patients with a rheumatoid arthritis diagnosis, according to their primary rheumatologist who agrees to participate
Key exclusion criteria (1 listed)
- Patients with a not confirmed rheumatoid arthritis diagnosis
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 |
|---|---|---|
| Rheumatic diseases Mistreatment Scale (RDMS)Also: RD-MSIn 2012, Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS); translation, cultural adaptation, and validation were performed prior to its application. | Other | Patients with rheumatoid arthritis |
| Routine assessment of patient index data 3 (RAPID-3)Also: RAPID-3RAPID- 3 measures: function, pain, and patient global status estimate. Each of the three individual measures is scored 0 to 10, for a total of 30 | Other | Patients with rheumatoid arthritis |
| Health Assessment Questionnaire (HAQ)Also: HAQThe HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality. | Other | Patients with rheumatoid arthritis |
| WHOQOL-BREFWHOQOL-BREF is a 26-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items | Other | Patients with rheumatoid arthritis |
| Depression, Anxiety and Stress Scale (DASS-21)Also: DASS-21DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content. | Other | Patients with rheumatoid arthritis |
| Brief Resilient Coping ScaleAlso: BRCSThe Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner. | Other | Patients with rheumatoid arthritis |
| Expression of CDKN2A /p16INK4aCDKN2A/p16INK4a expression will be measured using the Taqman qPCR assay (TaqMan Universal Master Mix II, with UNG, Applied Biosystems, Foster City, USA) according to the manufacturer's specifications. | Genetic | Patients with rheumatoid arthritis |
| Immunophenotype of leukocyte subpopulationsCD4+ and CD8+ subpopulations will be analyzed. Blood samples will be analyzed by 8-color flow cytometry (Becton Dickinson Canto II cytometer) using fluorescently labeled antibodies from Biolegend Inc. (San Diego, USA). | Other | Patients with rheumatoid arthritis |
| Telomere lengthThe rLTL will be estimated by quantitative monochromatic multiplex PCR (MM-qPCR). Integrated DNA Technologies, Inc. (IDT, Coralville, IA, USA) will synthesize the primers used for telomere measurements. | Genetic | Patients with rheumatoid arthritis |
| Cellular senescenceExpression of co-stimulatory molecules and surface receptors CD27- and CD28- | Other | Patients with rheumatoid arthritis |
Primary outcome
Adversity and senescence in patients with rheumatoid arthritis
Time frame: At inclusion (baseline moment) (cross-sectional study)]
To evaluate whether the presence of adversity (history of abuse in childhood and/or abuse associated with RD) is associated with markers of senescence in patients with rheumatoid arthritis.
2 secondary outcomes
Eexpression of the p16INK4a gene in CD3+
Time frame: At inclusion (baseline moment) (cross-sectional study)]
Telomere length
Time frame: At inclusion (baseline moment) (cross-sectional study)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Results publication: PubMed 34048701Baumer Y, Powell-Wiley TM. Interdisciplinary approaches are fundamental to decode the biology of adversity. Cell. 2021 May 27;184(11):2797-2801. doi: 10.1016/j.cell.2021.04.010.
- 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.
Virginia MD Pascual-Ramos, MD principal investigator
IInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Questions about this trial
What is this clinical trial studying?
An observational study of RhA - Rheumatoid Arthritis, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginia MD Pascual-Ramos, MD (525555734111 ext. 533, virtichu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adversity and senescence in patients with rheumatoid arthritis (time frame: At inclusion (baseline moment) (cross-sectional study)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06386380, which also lists 1 linked publication.
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 3 May 2024.