AGR+PNI as Predictors of Systemic Lupus Erythematosus Disease Activity

NCT ID: NCT07043153

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to evaluate the clinical utility of combining the albumin to globulin ratio (AGR) and the prognostic nutritional index (PNI) as a predictive model for assessing disease activity in patients with systemic lupus erythematosus (SLE). By correlating these nutritional and inflammatory markers with clinical manifestations and laboratory parameters, we hope to establish a simple, non-invasive, and cost-effective tool to aid in monitoring disease activity in Systemic lupus erythematosus patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active SLE group:patients with active (SLE), fulfilling the ACR/EULAR classification criteria,

Albumin to globulin ratio and prognostic nutritional index model

Intervention Type DIAGNOSTIC_TEST

Measurement of albumin to globulin ratio and prognostic nutritional index in participants to assess disease activity in systemic lupus erythematosus patients

Healthy controls:Age and sex-matched healthy individuals without any history of autoimmune diseases

Albumin to globulin ratio and prognostic nutritional index model

Intervention Type DIAGNOSTIC_TEST

Measurement of albumin to globulin ratio and prognostic nutritional index in participants to assess disease activity in systemic lupus erythematosus patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Albumin to globulin ratio and prognostic nutritional index model

Measurement of albumin to globulin ratio and prognostic nutritional index in participants to assess disease activity in systemic lupus erythematosus patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* · Age ≥ 18 years.

* Both sexes.
* Patients diagnosed with SLE who fulfilling the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and matched controls.

Exclusion Criteria

* Co-existing chronic inflammatory or autoimmune diseases.
* Age \<18 years
* Malignancy.
* Pregnancy or lactation.
* Chronic liver or renal insufficiency.
* Malignant hematologic diseases.
* Active hepatitis.
* Acute infection within the previous four weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hala Abdellatif Hamed

Resident of Physical Medicine, Rheumatology and Rehabilitation Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Esam M Abualfadl, Professor

Role: STUDY_CHAIR

Sohag University

Rabab H Ali, MD

Role: STUDY_DIRECTOR

Sohag University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag University hospitals

Sohag, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hala A Hamid, Master

Role: CONTACT

20 01122385665

Esam M Abualfadl, Professor

Role: CONTACT

20 01125677779

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Magdy M Amin, Professor

Role: primary

0934602963

References

Explore related publications, articles, or registry entries linked to this study.

Idborg H, Eketjall S, Pettersson S, Gustafsson JT, Zickert A, Kvarnstrom M, Oke V, Jakobsson PJ, Gunnarsson I, Svenungsson E. TNF-alpha and plasma albumin as biomarkers of disease activity in systemic lupus erythematosus. Lupus Sci Med. 2018 Jun 4;5(1):e000260. doi: 10.1136/lupus-2018-000260. eCollection 2018.

Reference Type BACKGROUND
PMID: 29955370 (View on PubMed)

Guo X, Shao J, Zhai B, Zou Q, Yan J, Gu H, Wang G. Relationship and prognostic significance between preoperative serum albumin to globulin ratio and CT features of non-small cell lung cancer. Eur J Radiol. 2020 Jul;128:109039. doi: 10.1016/j.ejrad.2020.109039. Epub 2020 May 4.

Reference Type BACKGROUND
PMID: 32417713 (View on PubMed)

Barber MRW, Drenkard C, Falasinnu T, Hoi A, Mak A, Kow NY, Svenungsson E, Peterson J, Clarke AE, Ramsey-Goldman R. Global epidemiology of systemic lupus erythematosus. Nat Rev Rheumatol. 2021 Sep;17(9):515-532. doi: 10.1038/s41584-021-00668-1. Epub 2021 Aug 3.

Reference Type BACKGROUND
PMID: 34345022 (View on PubMed)

Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis. 2019 Sep;78(9):1151-1159. doi: 10.1136/annrheumdis-2018-214819. Epub 2019 Aug 5.

Reference Type BACKGROUND
PMID: 31383717 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med--25-6-1MS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AntiDFS70 Lupus Nephritis
NCT06119763 RECRUITING
Interleukin23 in Systemic Lupus
NCT06713187 RECRUITING NA
miR-101-3p and Autotaxin in SLE Patients
NCT07252141 NOT_YET_RECRUITING