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NCT Number: NCT07105566

Triosephosphate Isomerase Level in Relation to Rheumatoid Aerthritis Activity and Structural Damage

1. Assess the serum level of TPI in patients with RA compared to healthy controls. 2. Correlate serum level of TPI and disease activity. 3. Correlation of serum TPI level with US7 damage index

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Key information

About this study

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by persistent synovial inflammation, synovial hyperplasia, and progressive destruction of bone and cartilage. These pathological processes can lead to joint deformities and loss of function, significantly affecting patients' quality of life. In addition to joint damage, RA often manifests with extraarticular complications involving the cardiovascular, pulmonary, and other organ systems. These systemic effects impose a substantial burden on patients' physical and mental well-being, as well as their socioeconomic status .The disease often affects subjects between the ages of 40 and 70; however, it can also occur at a younger age. Globally, the prevalence rate of RA is approximately 1%, with females experiencing a higher incidence . Triosephosphate isomerase (TPI) is a metabolic enzyme that regulates the flow of glycolysis and energy generation by converting dihydroxyacetone phosphate (DHAP) into D- glyceraldehyde 3-phosphate (G3P). TPI is one of the glycolytic enzymes implicated in the pathogenesis of RA.

Additionally, it has been shown to possess functions beyond glycolysis, including potential roles in the nucleus related to cancer pathogenesis and chemotherapy resistance . Some studies showed a significant correlation between elevated TPI levels and RA, with TPI serving as an independent predictor of the disease. With some findings, which include a high sensitivity of 98.5% and specificity of 100%, suggest that TPI could be a valuable biomarker for the early diagnosis and management of RA

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with RA who fulfill 2010 ACR/EULAR classification criteria

Exclusion criteria

  • Individuals with uncontrolled chronic diseases such as hypertension , diabetes, heart disease, liver or kidney disease, other autoimmune disorders and tumors.
  • Pregnant women.
  • Rheumatologic diseases other than RA

Treatment and study plan

serum TPI

Diagnostic Test

serum TPI level

Other names: ultrasound

Primary outcomes

  1. Serum Triosephosphate Isomerase (TPI) concentration (ng/mL) in Rheumatoid Arthritis (RA) patients

    Time frame: baseline

    This outcome assesses the quantitative difference in serum TPI concentrations, measured in nanograms per milliliter (ng/mL), between patients diagnosed with Rheumatoid Arthritis and age- and sex-matched healthy individuals.

Secondary outcomes

  1. Correlation of serum TPI with Rheumatoid Arthritis disease activity markers

    Time frame: baseline

    This outcome assesses the association between serum TPI levels (ng/mL) and established disease activity markers in RA patients, specifically Disease Activity Score in 28 joints with ESR (DAS28-ESR)

Study contacts

Contact information is provided by the study sponsor or research team.

Nada Mohsen

CONTACT

[email protected]

01020930427

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Serum Triosephosphate Isomerase Level in Pateints With Rheumatoid Arthritis : Relation to Disease Activity and Structural Damage

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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