Clinical trial NCT04293510: Evaluation of Janus Kinase_3 in Juvenile Onset Systemic Lupus Erythematosus
Official title: Evaluation of Janus Kinase_3 Expression in Juvenile Onset Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Keywords: Janus-kinase3
active
lupus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 67
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Janus-kinase 3 expression
timeFrame: within 2 years
Secondary outcomes:
measure: correlation
timeFrame: 2 years
Other outcomes:
measure: correlation
timeFrame: 2 years
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.