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

Not yet recruiting

• Conditions: RhA - Rheumatoid Arthritis
• Interventions: 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

• Registration Number: NCT06386380
• Lead Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran

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.

Study Timeline

• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03
• Study Start: 2024-06-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with rheumatoid arthritis	Routine assessment of patient index data 3 (RAPID-3)	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Patients with rheumatoid arthritis	Brief Resilient Coping Scale	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Patients with rheumatoid arthritis	Telomere length	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Patients with rheumatoid arthritis	Rheumatic diseases Mistreatment Scale (RDMS)	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Patients with rheumatoid arthritis	Health Assessment Questionnaire (HAQ)	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Patients with rheumatoid arthritis	WHOQOL-BREF	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Patients with rheumatoid arthritis	Immunophenotype of leukocyte subpopulations	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Patients with rheumatoid arthritis	Depression, Anxiety and Stress Scale (DASS-21)	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Patients with rheumatoid arthritis	Expression of CDKN2A /p16INK4a	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences
Patients with rheumatoid arthritis	Cellular senescence	Patients with rheumatoid arthritis outpatients from the National Institute of Medical Sciences

Primary Outcome Measures

Name	Time	Method
Adversity and senescence in patients with rheumatoid arthritis	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.

Secondary Outcome Measures

Name	Time	Method
Eexpression of the p16INK4a gene in CD3+	At inclusion (baseline moment) (cross-sectional study)]	Compare the relative expression of the p16INK4a gene in CD3+ lymphocytes between rheumatoid arthritis patients with and without adversity.
Telomere length	At inclusion (baseline moment) (cross-sectional study)]	Compare telomere length between RA patients with and without adversity.