Systemic Lupus Erythematosus DiseaseNCT07043153
AGR+PNI as Predictors of Systemic Lupus Erythematosus Disease Activity
An observational study of Systemic Lupus Erythematosus Disease, run by Sohag University at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus Disease
- What is being tested?
- Albumin to globulin ratio and prognostic nutritional index model
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2025to Jun 2026
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Group 1:patients aged 18 year and older both males and females diagnosed with systemic lupus erythematosus fulfilling the systemic lupus international collaborating clincs (SLICC) admitted to Physical Medicine, Rheumatology and Rehabilitation Department .
Who may be able to join
- · Age ≥ 18 years.
- Both sexes.
- Patients diagnosed with SLE who fulfilling the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and matched controls.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Esam M Abualfadl, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor, 0934602963, Portal@med.sohag.edu.eg
About this study
Official title: Using Combination of Albumin to Globulin Ratio and Prognostic Nutritional Index Model for Predicting Disease Activity in Patients With Systemic Lupus Erythematosus
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.
- Conditions
- Systemic Lupus Erythematosus Disease
- Being tested
- Albumin to globulin ratio and prognostic nutritional index model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin to globulin ratio and prognostic nutritional index modelDiagnostic test
Measurement of albumin to globulin ratio and prognostic nutritional index in participants to assess disease activity in systemic lupus erythematosus patients
| Study group | Role | What they receive |
|---|---|---|
| Active SLE group:patients with active (SLE), fulfilling the ACR/EULAR classification criteria, | Not described Receives: Diagnostic Test: Albumin to globulin ratio and prognostic nutritional index model | |
| Healthy controls:Age and sex-matched healthy individuals without any history of autoimmune diseases | Not described Receives: Diagnostic Test: Albumin to globulin ratio and prognostic nutritional index model |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the utility of the albumin-to-globulin ratio (AGR) as reliable, non-invasive biomarker for predicting disease activity in patients with systemic lupus erythematosus (SLE).
Measured: From 6 month to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start5 Aug 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Abdellatif Hamed, Sohag University
- Investigators
- Esam M Abualfadl, Professor, Study chair, Sohag UniversityRabab H Ali, MD, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043153
- Sponsor's protocol ID
- Soh-Med--25-6-1MS
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29955370Guo 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.
PubMed 32417713Barber 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.
PubMed 34345022Aringer 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.
PubMed 31383717
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Combination of Albumin to Globulin Ratio and Prognostic Nutritional Index Model for Predicting Disease Activity in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07043153
- Acronym / sponsor ID
- Soh-Med--25-6-1MS
- Conditions
- Systemic Lupus Erythematosus Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active SLE group:patients with active (SLE), fulfilling the ACR/EULAR classification criteria, | – | Diagnostic Test: Albumin to globulin ratio and prognostic nutritional index model |
| Healthy controls:Age and sex-matched healthy individuals without any history of autoimmune diseases | – | Diagnostic Test: Albumin to globulin ratio and prognostic nutritional index model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Group 1:patients aged 18 year and older both males and females diagnosed with systemic lupus erythematosus fulfilling the systemic lupus international collaborating clincs (SLICC) admitted to Physical Medicine, Rheumatology and Rehabilitation Department .
Key inclusion criteria (3 listed)
- · Age ≥ 18 years.
Key exclusion criteria (8 listed)
- Co-existing chronic inflammatory or autoimmune diseases.
- Age <18 years
- Malignancy.
- Pregnancy or lactation.
- Chronic liver or renal insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin to globulin ratio and prognostic nutritional index modelMeasurement of albumin to globulin ratio and prognostic nutritional index in participants to assess disease activity in systemic lupus erythematosus patients | Diagnostic test | Active SLE group:patients with active (SLE), fulfilling the ACR/EULAR classification criteria,, Healthy controls:Age and sex-matched healthy individuals without any history of autoimmune diseases |
Primary outcome
assess the utility of the albumin-to-globulin ratio (AGR) as reliable, non-invasive biomarker for predicting disease activity in patients with systemic lupus erythematosus (SLE).
Time frame: From 6 month to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Results publication: PubMed 29955370Idborg 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.
- Results publication: PubMed 32417713Guo 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.
- Results publication: PubMed 34345022Barber 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.
- Results publication: PubMed 31383717Aringer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esam M Abualfadl, Professor contact
Esam M Abualfadl, Professor study chair
Sohag University
Rabab H Ali, MD study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus Disease, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hala A Hamid, Master (20 01122385665, Hala.hamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the utility of the albumin-to-globulin ratio (AGR) as reliable, non-invasive biomarker for predicting disease activity in patients with systemic lupus erythematosus (SLE). (time frame: From 6 month to one year). 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 NCT07043153, which also lists 4 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 13 May 2026.