An observational study in RhA - Rheumatoid Arthritis, sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran · Observational
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.
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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 110 is below the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →National Institute of Medical Sciences and Nutrition, Salvador Zubiran is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All the patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
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
In 2012, Giraldo-Rodríguez developed and validated the Geriatric Mistreatment Scale (GAS); translation, cultural adaptation, and validation were performed prior to its application.
Also known as: RD-MS
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
Also known as: RAPID-3
The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality.
Also known as: HAQ
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
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.
Also known as: DASS-21
The Brief Resilient Coping Scale is a 4-item measure designed to capture tendencies to cope with stress in a highly adaptive manner.
Also known as: BRCS
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.
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).
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.
Expression of co-stimulatory molecules and surface receptors CD27- and CD28-
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.
Time frame: At inclusion (baseline moment) (cross-sectional study)]
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.
Time frame: At inclusion (baseline moment) (cross-sectional study)]
Telomere length
Compare telomere length between RA patients with and without adversity.
Time frame: At inclusion (baseline moment) (cross-sectional study)]
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jun 2024; primary completion for Jan 2026, 19 months later.
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This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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National Institute of Medical Sciences and Nutrition, Salvador Zubiran