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Rheumatoid ArthritisNCT07105566

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

An observational study of Rheumatoid Arthritis, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
serum TPI
How many people
70 participants
Where
No sites listed yet
Study dates
Sep 2025to Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Adult

Study population: Adult RA patients and age- and sex-matched healthy controls will be included

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Nada Mohsen contact

01020930427

nadamohsen702@gmail.com

About this study

Official title: Serum Triosephosphate Isomerase Level in Pateints With Rheumatoid Arthritis : Relation to Disease 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
Read the detailed description

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

Being tested
serum TPI
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • serum TPIDiagnostic test

    Also called ultrasound

    serum TPI level

Study groups in NCT07105566
Study groupRoleWhat they receive
casesRheumatoid Arthritis pateints
Receives: Diagnostic Test: serum TPI
controlshealthy controls
Receives: Diagnostic Test: serum TPI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: baseline

Secondary outcomes (1)

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

    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)

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07105566
Sponsor's protocol ID
TPI level in RA patients
Status last verified
Aug 2025
First submitted
16 Jul 2025
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Smolen JS, Aletaha D, Barton A, Burmester GR, Emery P, Firestein GS, Kavanaugh A, McInnes IB, Solomon DH, Strand V, Yamamoto K. Rheumatoid arthritis. Nat Rev Dis Primers. 2018 Feb 8;4:18001. doi: 10.1038/nrdp.2018.1.

    PubMed 29417936

  • Zuo J, Tang J, Lu M, Zhou Z, Li Y, Tian H, Liu E, Gao B, Liu T, Shao P. Glycolysis Rate-Limiting Enzymes: Novel Potential Regulators of Rheumatoid Arthritis Pathogenesis. Front Immunol. 2021 Nov 24;12:779787. doi: 10.3389/fimmu.2021.779787. eCollection 2021.

    PubMed 34899740

  • Escal J, Neel T, Hodin S, Boussoualim K, Amouzougan A, Coassy A, Locrelle H, Thomas T, Delavenne X, Marotte H. Proteomics analyses of human plasma reveal triosephosphate isomerase as a potential blood marker of methotrexate resistance in rheumatoid arthritis. Rheumatology (Oxford). 2024 May 2;63(5):1368-1376. doi: 10.1093/rheumatology/kead390.

    PubMed 37527020

  • Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.

    PubMed 20872595

  • Medina YF, Ruiz-Gaviria RE, Buitrago-Lopez A, Villota C. Physical articular examination in the activity of rheumatoid arthritis: a systematic review of the literature : Systematic review of the literature regarding physical examination in rheumatoid arthritis. Clin Rheumatol. 2018 Jun;37(6):1457-1464. doi: 10.1007/s10067-018-4015-4. Epub 2018 Feb 20.

    PubMed 29464524

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nada Mohsen (01020930427, nadamohsen702@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Triosephosphate Isomerase (TPI) concentration (ng/mL) in Rheumatoid Arthritis (RA) patients (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07105566, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

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