NCT07105566

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Sep 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Sep 2025Oct 2027

First Submitted

Initial submission to the registry

July 16, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

July 16, 2025

Last Update Submit

August 2, 2025

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (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.

    baseline

Secondary Outcomes (1)

  • Correlation of serum TPI with Rheumatoid Arthritis disease activity markers

    baseline

Study Arms (2)

cases

Rheumatoid Arthritis pateints

Diagnostic Test: serum TPI

controls

healthy controls

Diagnostic Test: serum TPI

Interventions

serum TPIDIAGNOSTIC_TEST

serum TPI level

Also known as: ultrasound
casescontrols

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 29417936BACKGROUND

  • 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.

    PMID: 34899740BACKGROUND

  • 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.

    PMID: 37527020BACKGROUND

  • 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.

    PMID: 20872595BACKGROUND

  • 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.

    PMID: 29464524BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Safaa Mahran, proff

    World Health Organization

    STUDY DIRECTOR

Central Study Contacts

Nada Mohsen

CONTACT

01020930427nadamohsen702@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2025

First Posted

August 6, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share