Adversity and Its Association With the Development and Expression of Rheumatic Diseases

NCT06386380 | Not Yet Recruiting

• 1 other identifier: IRE-4906
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

RhA - Rheumatoid Arthritis

Keywords

Adversity; Rheumatic diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  At inclusion (baseline moment) (cross-sectional study)]

Secondary Outcomes (2)

• Eexpression of the p16INK4a gene in CD3+

  At inclusion (baseline moment) (cross-sectional study)]

• Telomere length

  At inclusion (baseline moment) (cross-sectional study)]

Study Arms (1)

Patients with rheumatoid arthritis

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

Interventions

Rheumatic diseases Mistreatment Scale (RDMS) OTHER

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

Patients with rheumatoid arthritis

Routine assessment of patient index data 3 (RAPID-3) OTHER

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

Patients with rheumatoid arthritis

Health Assessment Questionnaire (HAQ) OTHER

The HAQ is based on five patient-centered dimensions: disability, pain, medication effects, costs of care, and mortality.

Also known as: HAQ

Patients with rheumatoid arthritis

WHOQOL-BREF OTHER

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

Patients with rheumatoid arthritis

Depression, Anxiety and Stress Scale (DASS-21) OTHER

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

Patients with rheumatoid arthritis

Brief Resilient Coping Scale OTHER

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

Patients with rheumatoid arthritis

Expression of CDKN2A /p16INK4a GENETIC

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.

Patients with rheumatoid arthritis

Immunophenotype of leukocyte subpopulations OTHER

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).

Patients with rheumatoid arthritis

Telomere length GENETIC

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.

Patients with rheumatoid arthritis

Cellular senescence OTHER

Expression of co-stimulatory molecules and surface receptors CD27- and CD28-

Patients with rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences

You may qualify if:

• Patients with a rheumatoid arthritis diagnosis, according to their primary rheumatologist who agrees to participate

You may not qualify if:

• Patients with a not confirmed rheumatoid arthritis diagnosis

Sponsors & Collaborators

• National Institute of Medical Sciences and Nutrition, Salvador Zubiran: lead

Related Publications (1)

• 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.

  PMID: 34048701 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

A 10 ml peripheral blood sample will be taken by venipuncture with the Vacutainer® system in tubes with EDTA anticoagulant. DNA will be extracted using the commercial Wizard® system (Promega TM cat: A1620) based on salt precipitation. The extracted DNA will be quantified in a Nanodrop spectrophotometer, diluted, and preserved at -20°C until use. The Institute's Cellular Immunology and Genetics laboratories will analyze the DNA.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Rheumatic Diseases

Interventions

ametantrone; Cyclin-Dependent Kinase Inhibitor p16; Cellular Senescence

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclin-Dependent Kinase Inhibitor Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Cell Cycle Proteins; Proteins; Tumor Suppressor Proteins; Neoplasm Proteins; Cell Physiological Phenomena; Aging; Growth and Development; Physiological Phenomena

Study Officials

• Virginia MD Pascual-Ramos, MD

  IInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia MD Pascual-Ramos, MD

CONTACT

525555734111; virtichu@gmail.com

Irazu MD Contreras-Yáñez, MD

CONTACT

525555734111; virtichu@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share