Clinical trial NCT06386380: Adversity and Its Association With the Development and Expression of Rheumatic Diseases
Official title: Adversity and Its Association With the Development and Expression of Rheumatic Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: RhA - Rheumatoid Arthritis
Keywords: Adversity
Rheumatic diseases
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with a not confirmed rheumatoid arthritis diagnosis

Primary outcomes:
measure: Adversity and senescence in patients with rheumatoid arthritis
timeFrame: At inclusion (baseline moment) (cross-sectional study)]
Secondary outcomes:
measure: Eexpression of the p16INK4a gene in CD3+
timeFrame: At inclusion (baseline moment) (cross-sectional study)]
measure: Telomere length
timeFrame: At inclusion (baseline moment) (cross-sectional study)]
Other outcomes:
Locations:
Study officials:
affiliation: IInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
name: Virginia MD Pascual-Ramos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.