Systemic Lupus ErythematosusNCT06255743
(Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-ds DNA Antibodies) and Relation to Depression and Anxiety in SLE
A study testing Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies in people with Systemic Lupus Erythematosus, run by Sohag University at 1 site in Egypt.
Trial summary
the study determine the relation between the degree of (Depression and Anxiety) in Systemic Lupus Erythematosus Patients by zung self rating depression scale and zung self rating anxiety scale and (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2024to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who fulfill the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria or 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematosus.
- Patients who is able to give informed consent to join the study.
Who cannot join
- - Any patient with any autoimmune disease other than systemic lupus erythematosus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Faculty of Medicine
Sohag
Osama S Daif Allah, Assistant Professor, 01006425746, hebamaher1919@gmail.com
Heba M Kamaly, Assistant lecture, 01093128552, hebamaher1919@gmail.com
About this study
Official title: (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies) Correlate With Depression and Anxiety in Systemic Lupus Erythematosus Patients
the study determine the relation between the degree of (Depression and Anxiety) in Systemic Lupus Erythematosus Patients by zung self rating depression scale and zung self rating anxiety scale and (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies
- Keywords
- Depression -Anxiety-Anti-Ribosomal P Protein Antibody - Anti-U1 Antibody - Anti-Nucleosome Antibody - Anti-Double Strad DNA Antibody
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA AntibodiesDiagnostic test
determine Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies) and its relation to the degree of Depression and Anxiety in Systemic Lupus Erythematosus Patients
| Study group | Role | What they receive |
|---|---|---|
| case | Experimental | cases diagnosed systemic lupus erythematosus we measure degree of depression and anxiety and relation to (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-ds DNA Antibodies) Receives: Diagnostic Test: Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
the degree of depression
by using zung self-rating depression scale
Measured: 1 year
the degree of anxiety
by using zung self-rating anxiety scale
Measured: 1 year
Secondary outcomes (4)
Anti-Ribosomal P Protein antibody
was examined by ANA profile by immunoblot based assay with which the plasma of heparin-anticoagulated venous blood and there of IgG antibodies reacted against the auto-antigens are tested.
Measured: 1 year
Anti-U1 RNP antibody
was examined by ANA profile by immunoblot based assay with which the plasma of heparin-anticoagulated venous blood and there of IgG antibodies reacted against the auto-antigens are tested.
Measured: 1 year
Anti-Nucleosome antibody
was examined by ANA profile by immunoblot based assay with which the plasma of heparin-anticoagulated venous blood and there of IgG antibodies reacted against the auto-antigens are tested.
Measured: 1 year
Anti-Double Strad DNA Antibody
was examined by ANA profile by immunoblot based assay with which the plasma of heparin-anticoagulated venous blood and there of IgG antibodies reacted against the auto-antigens are tested.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start14 Feb 2024 (estimated)
- Primary completion14 Dec 2024 (estimated)
- Study completion14 Feb 2025 (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 Systemic Lupus ErythematosusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Maher Kamaly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255743
- Sponsor's protocol ID
- Soh-Med-24-01-07MD
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amoura Z, Koutouzov S, Chabre H, Cacoub P, Amoura I, Musset L, Bach JF, Piette JC. Presence of antinucleosome autoantibodies in a restricted set of connective tissue diseases: antinucleosome antibodies of the IgG3 subclass are markers of renal pathogenicity in systemic lupus erythematosus. Arthritis Rheum. 2000 Jan;43(1):76-84. doi: 10.1002/1529-0131(200001)43:13.0.CO;2-I.
PubMed 10643702Benito-Garcia E, Schur PH, Lahita R; American College of Rheumatology Ad Hoc Committee on Immunologic Testing Guidelines. Guidelines for immunologic laboratory testing in the rheumatic diseases: anti-Sm and anti-RNP antibody tests. Arthritis Rheum. 2004 Dec 15;51(6):1030-44. doi: 10.1002/art.20836. No abstract available.
PubMed 15593352Diamond B, Bloom O, Al Abed Y, Kowal C, Huerta PT, Volpe BT. Moving towards a cure: blocking pathogenic antibodies in systemic lupus erythematosus. J Intern Med. 2011 Jan;269(1):36-44. doi: 10.1111/j.1365-2796.2010.02318.x.
PubMed 21158976Schattner E, Shahar G, Lerman S, Shakra MA. Depression in systemic lupus erythematosus: the key role of illness intrusiveness and concealment of symptoms. Psychiatry. 2010 Winter;73(4):329-40. doi: 10.1521/psyc.2010.73.4.329.
PubMed 21198385Gao HX, Campbell SR, Cui MH, Zong P, Hee-Hwang J, Gulinello M, Putterman C. Depression is an early disease manifestation in lupus-prone MRL/lpr mice. J Neuroimmunol. 2009 Feb 15;207(1-2):45-56. doi: 10.1016/j.jneuroim.2008.11.009. Epub 2009 Jan 3.
PubMed 19121871
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies) Correlate With Depression and Anxiety in Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT06255743
- Acronym / sponsor ID
- Soh-Med-24-01-07MD
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Depression -Anxiety-Anti-Ribosomal P Protein Antibody - Anti-U1 Antibody - Anti-Nucleosome Antibody - Anti-Double Strad DNA Antibody
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Feb 2024 (estimated)
- Primary completion
- 14 Dec 2024 (estimated)
- Study completion
- 14 Feb 2025 (estimated)
- First posted
- 13 Feb 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.
the study determine the relation between the degree of (Depression and Anxiety) in Systemic Lupus Erythematosus Patients by zung self rating depression scale and zung self rating anxiety scale and (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case | Experimental | Diagnostic Test: Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodiescases diagnosed systemic lupus erythematosus we measure degree of depression and anxiety and relation to (Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-ds DNA Antibodies) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who fulfill the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria or 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematosus.
- Patients who is able to give informed consent to join the study.
Key exclusion criteria (1 listed)
- - Any patient with any autoimmune disease other than systemic lupus erythematosus.
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 |
|---|---|---|
| Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodiesdetermine Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies) and its relation to the degree of Depression and Anxiety in Systemic Lupus Erythematosus Patients | Diagnostic test | case |
Primary outcome
the degree of depression
Time frame: 1 year
by using zung self-rating depression scale
the degree of anxiety
Time frame: 1 year
by using zung self-rating anxiety scale
4 secondary outcomes
Anti-Ribosomal P Protein antibody
Time frame: 1 year
Anti-U1 RNP antibody
Time frame: 1 year
Anti-Nucleosome antibody
Time frame: 1 year
Anti-Double Strad DNA Antibody
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 10643702Amoura Z, Koutouzov S, Chabre H, Cacoub P, Amoura I, Musset L, Bach JF, Piette JC. Presence of antinucleosome autoantibodies in a restricted set of connective tissue diseases: antinucleosome antibodies of the IgG3 subclass are markers of renal pathogenicity in systemic lupus erythematosus. Arthritis Rheum. 2000 Jan;43(1):76-84. doi: 10.1002/1529-0131(200001)43:13.0.CO;2-I.
- Background: PubMed 15593352Benito-Garcia E, Schur PH, Lahita R; American College of Rheumatology Ad Hoc Committee on Immunologic Testing Guidelines. Guidelines for immunologic laboratory testing in the rheumatic diseases: anti-Sm and anti-RNP antibody tests. Arthritis Rheum. 2004 Dec 15;51(6):1030-44. doi: 10.1002/art.20836. No abstract available.
- Background: PubMed 21158976Diamond B, Bloom O, Al Abed Y, Kowal C, Huerta PT, Volpe BT. Moving towards a cure: blocking pathogenic antibodies in systemic lupus erythematosus. J Intern Med. 2011 Jan;269(1):36-44. doi: 10.1111/j.1365-2796.2010.02318.x.
- Background: PubMed 21198385Schattner E, Shahar G, Lerman S, Shakra MA. Depression in systemic lupus erythematosus: the key role of illness intrusiveness and concealment of symptoms. Psychiatry. 2010 Winter;73(4):329-40. doi: 10.1521/psyc.2010.73.4.329.
- Background: PubMed 19121871Gao HX, Campbell SR, Cui MH, Zong P, Hee-Hwang J, Gulinello M, Putterman C. Depression is an early disease manifestation in lupus-prone MRL/lpr mice. J Neuroimmunol. 2009 Feb 15;207(1-2):45-56. doi: 10.1016/j.jneuroim.2008.11.009. Epub 2009 Jan 3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Ribosomal P Protein,Anti-U1 RNP, Anti-Nucleosome and Anti-Double Strad DNA Antibodies in people with Systemic Lupus Erythematosus, 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Osama S Daif Allah, Assistant Professor (01006425746, hebamaher1919@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the degree of depression (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06255743, 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 13 Feb 2024.