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NCT07536529Recruiting

Oxidative Stress in Autoimmune Rheumatic Diseases

Investigation of the Role of Redox Status of Patients With Autoimmune Rheumatic Diseases on Disease Progression: An Epidemiological Study

Source: ClinicalTrials.gov · Last updated 28 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
6 Apr 2026
Start date
6 Oct 2025
Primary completion date
30 Apr 2026
Lead sponsor
University of Thessaly
NCT number
NCT07536529

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 6 Oct 2025 to the primary completion date, 30 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Adult patients (\>18 years old) with concurrent infectious disease

Age

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

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
General University Hospital of Larissa. Greece
Coordinator of this site? Confirm its status
LarissaGreeceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.