Systemic Lupus ErythematosusNCT04293510
Evaluation of Janus Kinase_3 in Juvenile Onset Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
Trial summary
One of the best understood mechanisms by which cytokines activate signals, thus eliciting specific responses in target cells, involves enzymes such as Janus kinases (JAKs) and transcriptional factors such as signal transducers and activators of transcription (STATs). Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- renal biopsy and blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2020to 15 Jul 2022
- Phase
- Observational
- 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 7 to 16 years
- All sexes
- Child
Study population: This will include children and adolescents who fulfill the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria of systemic lupus erythromatosus during a period of 2 years.
Who may be able to join
- Age younger than 16 years.
- Active disease stage
- Patients with biopsy proven lupus nephritis according to ISN/RPS classification criteria of lupus nephritis
Who cannot join
- Lupus patients in remission.
- Lupus patients with end stage renal disease.
- Lupus patients with secondary thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS).
- patients with moderate or severe infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Janus Kinase_3 Expression in Juvenile Onset Systemic Lupus Erythematosus
One of the best understood mechanisms by which cytokines activate signals, thus eliciting specific responses in target cells, involves enzymes such as Janus kinases (JAKs) and transcriptional factors such as signal transducers and activators of transcription (STATs). For immune mediated diseases, both activating and inactivating mutations of JAKs and STATs may cause abnormalities in immune homeostasis. Polymorphisms of JAK/STAT genes have been linked to susceptibility for rheumatoid arthritis (RA) , systemic lupus erythematosus (SLE), psoriatic arthritis (PA) and inflammatory bowel disease (IBD) .
Janus_kinase 3 expression will be evaluated in the serum and renal tissue of lupus patients during active stage of the disease through this study
Read the detailed description
Investigators will assess the relationship between the expression of Janus_kinase 3 and the clinical and laboratory parameters of disease activity . Disease activity will be assessed through the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Also, investigators will evaluate the relationship between Janus_ kinase 3 expression and histopathological classes of lupus nephritis according to the 2003 International Society of Nephrology/ Renal Pathology Society (ISN/RPS) classification of lupus nephritis. This will be done through Janus_kinase 3 assessment in the blood and renal tissue of lupus patients.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- renal biopsy and blood sampling
- Keywords
- Janus-kinase3, active, lupus
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal biopsy and blood samplingProcedure or surgery
renal biopsy and blood sampling will be taken from lupus patients for evaluation of Janus-kinase 3
| Study group | Role | What they receive |
|---|---|---|
| group study 1 | children and adolescents who diagnosed as lupus patients Receives: Procedure: renal biopsy and blood sampling | |
| group study 2 | age and sex matched healthy children free from any infection with no family history of immunological diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Janus-kinase 3 expression
evaluation of Janus-kinase 3 expression in blood and renal tissue of lupus patients during active stage of disease
Measured: within 2 years
Secondary outcomes (1)
correlation
relationship between Janus- kinase expression and clinical and laboratory parameters of disease activity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start15 Jul 2020 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Jul 2022 (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 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
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, enas mohamed sayed ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293510
- Sponsor's protocol ID
- EKNL
- Status last verified
- Mar 2020
- First submitted
- 29 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yamaoka K, Saharinen P, Pesu M, Holt VE 3rd, Silvennoinen O, O'Shea JJ. The Janus kinases (Jaks). Genome Biol. 2004;5(12):253. doi: 10.1186/gb-2004-5-12-253. Epub 2004 Nov 30.
PubMed 15575979Remmers EF, Plenge RM, Lee AT, Graham RR, Hom G, Behrens TW, de Bakker PI, Le JM, Lee HS, Batliwalla F, Li W, Masters SL, Booty MG, Carulli JP, Padyukov L, Alfredsson L, Klareskog L, Chen WV, Amos CI, Criswell LA, Seldin MF, Kastner DL, Gregersen PK. STAT4 and the risk of rheumatoid arthritis and systemic lupus erythematosus. N Engl J Med. 2007 Sep 6;357(10):977-86. doi: 10.1056/NEJMoa073003.
PubMed 17804842Weening JJ, D'Agati VD, Schwartz MM, Seshan SV, Alpers CE, Appel GB, Balow JE, Bruijn JA, Cook T, Ferrario F, Fogo AB, Ginzler EM, Hebert L, Hill G, Hill P, Jennette JC, Kong NC, Lesavre P, Lockshin M, Looi LM, Makino H, Moura LA, Nagata M. The classification of glomerulonephritis in systemic lupus erythematosus revisited. J Am Soc Nephrol. 2004 Feb;15(2):241-50. doi: 10.1097/01.asn.0000108969.21691.5d.
PubMed 14747370Petri M. Review of classification criteria for systemic lupus erythematosus. Rheum Dis Clin North Am. 2005 May;31(2):245-54, vi. doi: 10.1016/j.rdc.2005.01.009.
PubMed 15922144
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Janus Kinase_3 Expression in Juvenile Onset Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04293510
- Acronym / sponsor ID
- EKNL
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Janus-kinase3, active, lupus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 3 Mar 2020 (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.
One of the best understood mechanisms by which cytokines activate signals, thus eliciting specific responses in target cells, involves enzymes such as Janus kinases (JAKs) and transcriptional factors such as signal transducers and activators of transcription (STATs). For immune mediated diseases, both activating and inactivating mutations of JAKs and STATs may cause abnormalities in immune homeostasis. Polymorphisms of JAK/STAT genes have been linked to susceptibility for rheumatoid arthritis (RA) , systemic lupus erythematosus (SLE), psoriatic arthritis (PA) and inflammatory bowel disease (IBD) .
Janus_kinase 3 expression will be evaluated in the serum and renal tissue of lupus patients during active stage of the disease through this study
Detailed description
Investigators will assess the relationship between the expression of Janus_kinase 3 and the clinical and laboratory parameters of disease activity . Disease activity will be assessed through the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Also, investigators will evaluate the relationship between Janus_ kinase 3 expression and histopathological classes of lupus nephritis according to the 2003 International Society of Nephrology/ Renal Pathology Society (ISN/RPS) classification of lupus nephritis. This will be done through Janus_kinase 3 assessment in the blood and renal tissue of lupus patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group study 1 | – | Procedure: renal biopsy and blood samplingchildren and adolescents who diagnosed as lupus patients |
| group study 2 | – | –age and sex matched healthy children free from any infection with no family history of immunological diseases |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- This will include children and adolescents who fulfill the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria of systemic lupus erythromatosus during a period of 2 years.
Key inclusion criteria (3 listed)
- Age younger than 16 years.
Key exclusion criteria (4 listed)
- Lupus patients in remission.
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 |
|---|---|---|
| renal biopsy and blood samplingrenal biopsy and blood sampling will be taken from lupus patients for evaluation of Janus-kinase 3 | Procedure or surgery | group study 1 |
Primary outcome
Janus-kinase 3 expression
Time frame: within 2 years
evaluation of Janus-kinase 3 expression in blood and renal tissue of lupus patients during active stage of disease
1 secondary outcome
correlation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Background: PubMed 15575979Yamaoka K, Saharinen P, Pesu M, Holt VE 3rd, Silvennoinen O, O'Shea JJ. The Janus kinases (Jaks). Genome Biol. 2004;5(12):253. doi: 10.1186/gb-2004-5-12-253. Epub 2004 Nov 30.
- Background: PubMed 17804842Remmers EF, Plenge RM, Lee AT, Graham RR, Hom G, Behrens TW, de Bakker PI, Le JM, Lee HS, Batliwalla F, Li W, Masters SL, Booty MG, Carulli JP, Padyukov L, Alfredsson L, Klareskog L, Chen WV, Amos CI, Criswell LA, Seldin MF, Kastner DL, Gregersen PK. STAT4 and the risk of rheumatoid arthritis and systemic lupus erythematosus. N Engl J Med. 2007 Sep 6;357(10):977-86. doi: 10.1056/NEJMoa073003.
- Background: PubMed 14747370Weening JJ, D'Agati VD, Schwartz MM, Seshan SV, Alpers CE, Appel GB, Balow JE, Bruijn JA, Cook T, Ferrario F, Fogo AB, Ginzler EM, Hebert L, Hill G, Hill P, Jennette JC, Kong NC, Lesavre P, Lockshin M, Looi LM, Makino H, Moura LA, Nagata M. The classification of glomerulonephritis in systemic lupus erythematosus revisited. J Am Soc Nephrol. 2004 Feb;15(2):241-50. doi: 10.1097/01.asn.0000108969.21691.5d.
- Background: PubMed 15922144Petri M. Review of classification criteria for systemic lupus erythematosus. Rheum Dis Clin North Am. 2005 May;31(2):245-54, vi. doi: 10.1016/j.rdc.2005.01.009.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
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 4 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Enas Mohamed Sayed Ahmed (01004870406, enasmhmd05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Janus-kinase 3 expression (time frame: within 2 years). 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 NCT04293510, 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 4 Mar 2020.