Evaluation of Janus Kinase_3 in Juvenile Onset Systemic Lupus Erythematosus

NCT ID: NCT04293510

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-07-15

Brief Summary

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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

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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

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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group study 1

children and adolescents who diagnosed as lupus patients

renal biopsy and blood sampling

Intervention Type PROCEDURE

renal biopsy and blood sampling will be taken from lupus patients for evaluation of Janus-kinase 3

group study 2

age and sex matched healthy children free from any infection with no family history of immunological diseases

No interventions assigned to this group

Interventions

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renal biopsy and blood sampling

renal biopsy and blood sampling will be taken from lupus patients for evaluation of Janus-kinase 3

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age younger than 16 years.

* Active disease stage
* Patients with biopsy proven lupus nephritis according to ISN/RPS classification criteria of lupus nephritis

Exclusion Criteria

* 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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enas mohamed sayed ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Enas Mohamed Sayed Ahmed

Role: CONTACT

01004870406

References

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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.

Reference Type BACKGROUND
PMID: 15575979 (View on PubMed)

Remmers 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.

Reference Type BACKGROUND
PMID: 17804842 (View on PubMed)

Weening 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.

Reference Type BACKGROUND
PMID: 14747370 (View on PubMed)

Petri 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.

Reference Type BACKGROUND
PMID: 15922144 (View on PubMed)

Other Identifiers

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EKNL

Identifier Type: -

Identifier Source: org_study_id

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