SpondyloarthropathyNCT06554392
Identification of Serum Level of Glutathione Peroxidase 4
An observational study of Spondyloarthropathy, run by Assiut University at 1 site in Egypt.
Trial summary
Analysis of the level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients. The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spondyloarthropathy
- What is being tested?
- Blood sample
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Jul 2028
- How long will I take part?
- 3 Years
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Patients will be selected from AS and axial psoriatic arthritis patients presented sequentially at the outpatient clinic and inpatient unit of the Department of Rheumatology, Rehabilitation and Physical Medicine. Faculty of Medicine .Assiut University.in addition to age and sex matched controls.
Who may be able to join
- Patients diagnosed as ankylosing spondylitis according to ASAS criteria . [13]
- Patients diagnosed as psoriatic arthritis according to CASPAR criteria. [14]
- Age (>18).
Who cannot join
- Patient with other autoimmune Rheumatic diseases.
- patients with any of the following conditions: I) severe liver and kidney dysfunction; II) hematopoietic diseases; III) infectious diseases; IV) tumors; or V) other wasting diseases. [15]
- patients received certain drugs (for example, sulfasalazine, artemisinin, statins), and experimental reagents (such as erastin) .[16]
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine- Assiut University
Asyut, 71515
Marwa Mahmoud abdelaziz, M.D, 0201069052233, marwa.ali3@med.aun.edu.eg
About this study
Official title: Identification of Glutathione Peroxidase 4 in Detecting Ferroptosis in Ankylosing Spondylitis and Axial Psoriatic Arthritis Patients .
- Analysis of the level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.
- The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.
Read the detailed description
Ferroptosis, first reported by Dixon et al. in 2012, is a form of non-apoptotic cell death driven by iron-dependent lipid reactive oxygen species (ROS) and accelerated by the accumulation of lipid peroxides, ultimately leading to oxidative damage to phospholipid membranes and cell death .
Ferroptosis could be induced by iron metabolism disorder, lipid peroxidation accumulation, deficiency of glutathione (GSH) and inactivation of the antioxidant enzyme glutathione peroxidase 4 (GPX4).
The morphological features of ferroptotic cells manifest as an aberrant mitochondrial ultrastructure, including a reduction in mitochondrial volume, an increase in mitochondrial membrane density, and the disappearance of mitochondrial cristae in ferroptotic cells .
Recent studies have increasingly reported on complex associations between ferroptosis and the immune system . The regulatory activity of ferroptosis in immune function and inflammation is multifaceted and involves innate, acquired, and autoimmunity.
Accumulating evidence in recent times has shown an association of ferroptosis with the pathogenesis and development of autoimmune diseases .
Spondyloarthropathy comprises a group of chronic inflammatory rheumatic diseases, including ankylosing spondylitis, reactive arthritis (Reiter syndrome), arthritis or spondylitis associated with inflammatory bowel disease, and psoriatic arthritis, as well as undifferentiated spondyloarthritis. These afflictions predominantly affect the axial skeleton, causing pain and stiffness.
Currently, research on ferroptosis is still in its early stages; therefore, exploring the pathogenesis of ferroptosis and its role in various diseases, and proposing effective and targeted treatment methods have significant theoretical significance and practical value.
- Conditions
- Spondyloarthropathy
- Being tested
- Blood sample
- Medical subject headings
- Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
Blood sample from each subject to detect Glutathione Peroxidase 4.
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing Spondylitis patients | Identification of Glutathione Peroxidase 4 in blood. Receives: Diagnostic Test: Blood sample | |
| Axial Psoriatic Arthritis Patients | Identification of Glutathione Peroxidase 4 in blood. Receives: Diagnostic Test: Blood sample | |
| healthy controls | Identification of Glutathione Peroxidase 4 in blood. Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.
Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients to detect ferroptosis process in those patients.
Measured: baseline
Secondary outcomes (1)
The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.
The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthropathyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 85 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mahmoud Abdelaziz, Assiut University
- Investigators
- Nesreen Ibrahim, M.D, Study director, Rheumatology,Rehabilition Department ,Assiut universityMarwa Mahmoud Abdelaziz, M.D, Principal investigator, Rheumatology,Rehabilition Department ,Assiut universityNada Mohamad, Study chair, Rheumatology,Rehabilition Department ,Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554392
- Sponsor's protocol ID
- Glutathione Peroxidase 4
- Status last verified
- Nov 2026
- First submitted
- 11 Aug 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dixon SJ, Lemberg KM, Lamprecht MR, Skouta R, Zaitsev EM, Gleason CE, Patel DN, Bauer AJ, Cantley AM, Yang WS, Morrison B 3rd, Stockwell BR. Ferroptosis: an iron-dependent form of nonapoptotic cell death. Cell. 2012 May 25;149(5):1060-72. doi: 10.1016/j.cell.2012.03.042.
PubMed 22632970Chen R, Zhu S, Zeng L, Wang Q, Sheng Y, Zhou B, Tang D, Kang R. AGER-Mediated Lipid Peroxidation Drives Caspase-11 Inflammasome Activation in Sepsis. Front Immunol. 2019 Aug 8;10:1904. doi: 10.3389/fimmu.2019.01904. eCollection 2019.
PubMed 31440260Yuan S, Wei C, Liu G, Zhang L, Li J, Li L, Cai S, Fang L. Sorafenib attenuates liver fibrosis by triggering hepatic stellate cell ferroptosis via HIF-1alpha/SLC7A11 pathway. Cell Prolif. 2022 Jan;55(1):e13158. doi: 10.1111/cpr.13158. Epub 2021 Nov 22.
PubMed 34811833Gao M, Yi J, Zhu J, Minikes AM, Monian P, Thompson CB, Jiang X. Role of Mitochondria in Ferroptosis. Mol Cell. 2019 Jan 17;73(2):354-363.e3. doi: 10.1016/j.molcel.2018.10.042. Epub 2018 Dec 20.
PubMed 30581146Chen X, Kang R, Kroemer G, Tang D. Ferroptosis in infection, inflammation, and immunity. J Exp Med. 2021 Jun 7;218(6):e20210518. doi: 10.1084/jem.20210518. Epub 2021 May 12.
PubMed 33978684
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Glutathione Peroxidase 4 in Detecting Ferroptosis in Ankylosing Spondylitis and Axial Psoriatic Arthritis Patients .
- ClinicalTrials.gov ID
- NCT06554392
- Acronym / sponsor ID
- Glutathione Peroxidase 4
- Conditions
- Spondyloarthropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 15 Aug 2024 (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.
- Analysis of the level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.
- The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.
Detailed description
Ferroptosis, first reported by Dixon et al. in 2012, is a form of non-apoptotic cell death driven by iron-dependent lipid reactive oxygen species (ROS) and accelerated by the accumulation of lipid peroxides, ultimately leading to oxidative damage to phospholipid membranes and cell death .
Ferroptosis could be induced by iron metabolism disorder, lipid peroxidation accumulation, deficiency of glutathione (GSH) and inactivation of the antioxidant enzyme glutathione peroxidase 4 (GPX4).
The morphological features of ferroptotic cells manifest as an aberrant mitochondrial ultrastructure, including a reduction in mitochondrial volume, an increase in mitochondrial membrane density, and the disappearance of mitochondrial cristae in ferroptotic cells .
Recent studies have increasingly reported on complex associations between ferroptosis and the immune system . The regulatory activity of ferroptosis in immune function and inflammation is multifaceted and involves innate, acquired, and autoimmunity.
Accumulating evidence in recent times has shown an association of ferroptosis with the pathogenesis and development of autoimmune diseases .
Spondyloarthropathy comprises a group of chronic inflammatory rheumatic diseases, including ankylosing spondylitis, reactive arthritis (Reiter syndrome), arthritis or spondylitis associated with inflammatory bowel disease, and psoriatic arthritis, as well as undifferentiated spondyloarthritis. These afflictions predominantly affect the axial skeleton, causing pain and stiffness.
Currently, research on ferroptosis is still in its early stages; therefore, exploring the pathogenesis of ferroptosis and its role in various diseases, and proposing effective and targeted treatment methods have significant theoretical significance and practical value.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ankylosing Spondylitis patients | – | Diagnostic Test: Blood sampleIdentification of Glutathione Peroxidase 4 in blood. |
| Axial Psoriatic Arthritis Patients | – | Diagnostic Test: Blood sampleIdentification of Glutathione Peroxidase 4 in blood. |
| healthy controls | – | Diagnostic Test: Blood sampleIdentification of Glutathione Peroxidase 4 in blood. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from AS and axial psoriatic arthritis patients presented sequentially at the outpatient clinic and inpatient unit of the Department of Rheumatology, Rehabilitation and Physical Medicine. Faculty of Medicine .Assiut University.in addition to age and sex matched controls.
Key inclusion criteria (3 listed)
- Patients diagnosed as ankylosing spondylitis according to ASAS criteria . [13]
- Patients diagnosed as psoriatic arthritis according to CASPAR criteria. [14]
- Age (>18).
Key exclusion criteria (3 listed)
- Patient with other autoimmune Rheumatic diseases.
- patients with any of the following conditions: I) severe liver and kidney dysfunction; II) hematopoietic diseases; III) infectious diseases; IV) tumors; or V) other wasting diseases. [15]
- patients received certain drugs (for example, sulfasalazine, artemisinin, statins), and experimental reagents (such as erastin) .[16]
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 |
|---|---|---|
| Blood sampleBlood sample from each subject to detect Glutathione Peroxidase 4. | Diagnostic test | Ankylosing Spondylitis patients, Axial Psoriatic Arthritis Patients, healthy controls |
Primary outcome
Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients.
Time frame: baseline
Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis patients to detect ferroptosis process in those patients.
1 secondary outcome
The association of glutathione peroxidase 4 (GPX4) with disease activity and severity in ankylosing spondylitis and axial psoriatic arthritis patients.
Time frame: baseline
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 5 Nov 2026.
- Background: PubMed 22632970Dixon SJ, Lemberg KM, Lamprecht MR, Skouta R, Zaitsev EM, Gleason CE, Patel DN, Bauer AJ, Cantley AM, Yang WS, Morrison B 3rd, Stockwell BR. Ferroptosis: an iron-dependent form of nonapoptotic cell death. Cell. 2012 May 25;149(5):1060-72. doi: 10.1016/j.cell.2012.03.042.
- Background: PubMed 31440260Chen R, Zhu S, Zeng L, Wang Q, Sheng Y, Zhou B, Tang D, Kang R. AGER-Mediated Lipid Peroxidation Drives Caspase-11 Inflammasome Activation in Sepsis. Front Immunol. 2019 Aug 8;10:1904. doi: 10.3389/fimmu.2019.01904. eCollection 2019.
- Background: PubMed 34811833Yuan S, Wei C, Liu G, Zhang L, Li J, Li L, Cai S, Fang L. Sorafenib attenuates liver fibrosis by triggering hepatic stellate cell ferroptosis via HIF-1alpha/SLC7A11 pathway. Cell Prolif. 2022 Jan;55(1):e13158. doi: 10.1111/cpr.13158. Epub 2021 Nov 22.
- Background: PubMed 30581146Gao M, Yi J, Zhu J, Minikes AM, Monian P, Thompson CB, Jiang X. Role of Mitochondria in Ferroptosis. Mol Cell. 2019 Jan 17;73(2):354-363.e3. doi: 10.1016/j.molcel.2018.10.042. Epub 2018 Dec 20.
- Background: PubMed 33978684Chen X, Kang R, Kroemer G, Tang D. Ferroptosis in infection, inflammation, and immunity. J Exp Med. 2021 Jun 7;218(6):e20210518. doi: 10.1084/jem.20210518. Epub 2021 May 12.
Related trials for Spondyloarthropathy
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Nesreen Ibrahim, M.D study director
Rheumatology,Rehabilition Department ,Assiut university
Marwa Mahmoud Abdelaziz, M.D principal investigator
Rheumatology,Rehabilition Department ,Assiut university
Nada Mohamad study chair
Rheumatology,Rehabilition Department ,Assiut 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 Spondyloarthropathy, run by Assiut 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 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 Marwa Mahmoud Abdelaziz, M.D (+201069052233, marwa.ali3@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the serum level of glutathione peroxidase 4 (GPX4) in ankylosing spondylitis and axial psoriatic arthritis 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 NCT06554392, 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 5 Nov 2026.