Systemic Lupus ErythematosusNCT05900232
Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus
A study testing Anti _KU antibodies in people with Systemic Lupus Erythematosus, run by Sohag University at 1 site in Egypt.
Trial summary
systemic lupus Erythematosus (SLE) is a multi system autoimmune disorder abroad spectrum of clinical presentations. Diagnosis of SLE depending on Systemic Lupus International Collaborating Clinics (SLICC) Criteria. Read more about this study
- Who is it for?
- Ages 17 to 60 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Anti _KU antibodies
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 1 Nov 2023
- 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 17 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all patients will fulfill the Systemic Lupus International Clinics(SLICC) classification criteria for Systemic Lupus Erythematosus.
Who cannot join
- any patient with any collagen disease other than SLE
Trial locations and contacts
1 site in 1 country.
Osama S Daifallah, Associate Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospitals
Sohag
Magdy M Amin, Professor
About this study
systemic lupus Erythematosus (SLE) is a multi system autoimmune disorder abroad spectrum of clinical presentations.
Diagnosis of SLE depending on Systemic Lupus International Collaborating Clinics (SLICC) Criteria.
Read more
SLICC Criteria requires either that a patient satisfy at least 4 of 17 Criteria including at least 1 of 11 clinical criteria and 1 of 6 immunological criteria or the patient has biopsy -proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA)or anti_double stranded DNA (dsDNA) antibodies.
Anti_KU antibodies included in (ANA), reported in many autoimmune disorders like SLE,Sjogren syndrome, idiopathic lung fibrosis and myositis.
So the aim of the work is to determine the relationship between Anti_KU antibodies and SLE manifestations.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Anti _KU antibodies
- 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 _KU antibodiesDiagnostic test
aim of the work is to determine the relationship between Anti_Ku antibodies and SLE manifestations the study will include 60 SLE cases diagnosed by SLICC criteria and the activity of SLE will be calculated by SELDAI criteria, which is tool composed of 24 clinical and laboratory variables.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti KU antibodies and its relationship with Systemic Lupus Erythematosus manifestations
the study will evaluate the titre of Anti KU
antibodies which is positive or negative in one patient and on the other side what is the manifestation of SLE that found in the same patient if the Anti KU Antibodies titre is positive
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 May 2023
- Primary completion15 Oct 2023 (estimated)
- Study completion1 Nov 2023 (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 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Abdelbasset Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900232
- Sponsor's protocol ID
- Soh-Med-23-05-05MD
- Status last verified
- Jun 2023
- First submitted
- 27 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mosca M, Bombardieri S. Assessing remission in systemic lupus erythematosus. Clin Exp Rheumatol. 2006 Nov-Dec;24(6 Suppl 43):S-99-104.
PubMed 17083771Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
PubMed 22553077Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.
PubMed 22129255Mimori T. Clinical significance of anti-Ku autoantibodies--a serologic marker of overlap syndrome? Intern Med. 2002 Dec;41(12):1096-8. doi: 10.2169/internalmedicine.41.1096. No abstract available.
PubMed 12521194
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti KU Antibodies and Its Relationship With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05900232
- Acronym / sponsor ID
- Soh-Med-23-05-05MD
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 12 Jun 2023 (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.
systemic lupus Erythematosus (SLE) is a multi system autoimmune disorder abroad spectrum of clinical presentations.
Diagnosis of SLE depending on Systemic Lupus International Collaborating Clinics (SLICC) Criteria.
SLICC Criteria requires either that a patient satisfy at least 4 of 17 Criteria including at least 1 of 11 clinical criteria and 1 of 6 immunological criteria or the patient has biopsy -proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA)or anti_double stranded DNA (dsDNA) antibodies.
Anti_KU antibodies included in (ANA), reported in many autoimmune disorders like SLE,Sjogren syndrome, idiopathic lung fibrosis and myositis.
So the aim of the work is to determine the relationship between Anti_KU antibodies and SLE manifestations.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 17 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all patients will fulfill the Systemic Lupus International Clinics(SLICC) classification criteria for Systemic Lupus Erythematosus.
Key exclusion criteria (1 listed)
- any patient with any collagen disease other than SLE
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 _KU antibodiesaim of the work is to determine the relationship between Anti_Ku antibodies and SLE manifestations the study will include 60 SLE cases diagnosed by SLICC criteria and the activity of SLE will be calculated by SELDAI criteria, which is tool composed of 24 clinical and laboratory variables. | Diagnostic test | – |
Primary outcome
Anti KU antibodies and its relationship with Systemic Lupus Erythematosus manifestations
Time frame: 6 months
the study will evaluate the titre of Anti KU antibodies which is positive or negative in one patient and on the other side what is the manifestation of SLE that found in the same patient if the Anti KU Antibodies titre is positive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 17083771Mosca M, Bombardieri S. Assessing remission in systemic lupus erythematosus. Clin Exp Rheumatol. 2006 Nov-Dec;24(6 Suppl 43):S-99-104.
- Background: PubMed 22553077Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
- Background: PubMed 22129255Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.
- Background: PubMed 12521194Mimori T. Clinical significance of anti-Ku autoantibodies--a serologic marker of overlap syndrome? Intern Med. 2002 Dec;41(12):1096-8. doi: 10.2169/internalmedicine.41.1096. No abstract available.
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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.
Osama S Daifallah, Associate Professor contact
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 _KU 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 1 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 12 Jun 2023. 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 Nehal A Ahmed, resident (01145379717, nehal011209@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti KU antibodies and its relationship with Systemic Lupus Erythematosus manifestations (time frame: 6 months). 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 NCT05900232, 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 12 Jun 2023.