Oxidative Stress in Autoimmune Rheumatic Diseases

NCT07536529 | Recruiting

• 2 other identifiers: 72/8.01.202542339/17/10/2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatic diseases constitute a group of non-communicable diseases characterized by chronic inflammation. The most common autoimmune rheumatic diseases (ARDs) are rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, myositis, Sjogren's syndrome and systemic scleroderma. These autoimmune disorders lead to joint destruction and adversely influence the human body systemically. One of their characteristics is comorbidity, since patients usually suffer also from other pathologies such as cardiovascular diseases and obesity. In addition, their treatment requires a combination of both biological and conventional pharmaceutical interventions as well as other parameters such as physical activity programs, nutrition, and the use of smart electronic devices. Therefore, the ARDs burden health systems worldwide. Apart from the physiological manifestations of ARDs, specific changes are observed at the cellular and molecular level. A common biochemical/molecular symptom of these diseases is oxidative stress. This condition leads to the disturbance of blood and tissue redox status due to the excessive production of free radicals. Given that free radicals are highly reactive moieties with strong oxidative capacity against biomolecules (i.e., proteins, lipids, DNA), they compromise the efficacy of the intrinsic antioxidant mechanisms and, finally, induce the disruption of redox homeostasis. However, there is no sufficient data linking the levels of redox status of patients with the progression of ARDs over time. Indeed, the onset and symptoms of ARDs are intertwined with the disruption of the patient redox homeostasis and the induction of oxidative stress. Concurrently, the absence of a completely effective pharmaceutical treatment emerges the need for the adoption of novel biomarkers for monitoring the severity of the symptoms and the evolution of ARDs in general. To that end, this study aims at first to investigate the blood redox status of patients with ARDs. Thus, specific redox biomarkers will be evaluated in the blood of patients in three time points (i.e., at Days 1, 180 and 360), and they will be associated with the clinical manifestations of their diseases. The ultimate goal is to clarify whether these biomarkers could putatively exert clinical significance, namely whether they could constitute an additional tool for the monitoring of the progression of these diseases in clinical practice.

Conditions

Inflammatory Joint Diseases; Rheumatoid Arthritis (RA); Psoriatic Arthritis (PsA); Ankylosing Spondylitis (AS)

Keywords

Rheumatoid arthritis; Psoriatic arthritis; Ankylosing spondylitis; Oxidative stress; Antioxidants

Outcome Measures

Primary Outcomes (1)

• Concentration of blood reduced glutathione (GSH)

  The concentration of reduced form of glutathione (GSH) as a crucial intrinsic antioxidant metabolite will be measured spectrophotometrically in erythrocytes.

  GSH concentration will compared between Day 1 and Days 180 and 360

Secondary Outcomes (15)

• Concentration of protein carbonyls in blood

  Protein carbonyl concentration will compared between Day 1 and Days 180 and 360

• Total antioxidant capacity (TAC) of blood

  TAC will be compared between Day 1 and Days 180 and 360

• Activity of erythrocyte catalase

  Catalase activity will be compared between Day 1 and Days 180 and 360

• Concentration of C-reactive protein (CRP) in blood

  CRP conentration will be compared between Day 1 and Days 180 and 360

• Erythrocyte sedimentation rate

  Erythrocyte sedimentation rate will be compared between Day 1 and Days 180 and 360]

Study Arms (5)

Patients with rheumatoid arthritis

No intervention

Patients with psoriatic arthritis

No intervention

Patients with ankylosing spondylitis

No intervention

Patients with systemic lupus erythematosus

No intervention

Patients with scleroderma

No intervention

Eligibility Criteria

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

Study Population

The study population comprises patients of the General University Hospital of Larissa

You may qualify if:

• Adult patients (\>18 years old), with a primary diagnosis of rheumatoid arthritis using the criteria of American College of Rheumatology (ACR)
• Adult patients (\>18 years old), with a primary diagnosis of psoriatic arthritis using the ClASsification criteria for Psoriatic Arthritis (CASPAR)
• Adult patients (\>18 years old), with a primary diagnosis of alkylosing spondyloarthritis using the criteria of Assessment of SpondyloArthritis international Society (ASAS) group
• Adult patients (\>18 years old) irrespective of gender
• Adult patients (\>18 years old) irrespective of ethnicity
• Adult patients (\>18 years old) irrespective of comorbidities
• Adult patients (\>18 years old) irrespective of socioeconomic background
• Adult patients (\>18 years old) with any disease status
• Adult patients (\>18 years old) with any disease duration
• Adult patients (\>18 years old) under any treatment scheme (e.g. non-steroidal anti-inflammatory drugs, steroids, disease-modifying anti-rheumatic drugs including biologics)

You may not qualify if:

• Adult patients (\>18 years old) with concurrent infectious disease
• Adult patients (\>18 years old) in pregnancy
• Patients under 18 years of age

Sponsors & Collaborators

• University of Thessaly: lead
• General University Hospital of Larissa: collaborator
• Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece: collaborator
• Dimitrios P. Bogdanos, Professor, Department of Rheumatology and Clinical Immunology, Larissa University Hospital: collaborator
• George Metsios, Professor, Department of Nutrition and Dietetics, University of Thessaly, Greece: collaborator

Study Sites (1)

General University Hospital of Larissa. Greece

Larissa, Thessaly, Greece

RECRUITING

Related Publications (4)

• Phull AR, Nasir B, Haq IU, Kim SJ. 2018. Oxidative stress, consequences and ROS mediated cellular signaling in rheumatoid arthritis. Chemico-biological interactions, 281, 7, 121-136.

  BACKGROUND

• Nitschke E, Gottesman K, Hamlett P, Mattar L, Robinson J, Tovar A, Rozga M. 2022. Impact of Nutrition and Physical Activity Interventions Provided by Nutrition and Exercise Practitioners for the Adult General Population: A Systematic Review and Meta-Analysis. Nutrients, 14(9): 1729.

  BACKGROUND

• World Health Organization Physical Activity 2022β. Available online: https://www.who.int/news-room/fact-sheets/detail/physical-activity.

  BACKGROUND

• World Health Organization Noncommunicable Diseases 2022α. Available online: https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples; Data from self-reported questionnaires

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 17, 2026
• Study Start: October 6, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

GR (1)