Evaluation of Janus Kinase_3 in Juvenile Onset Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Evaluation of Janus Kinase_3 Expression in Juvenile Onset Systemic Lupus Erythematosus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04293510
• Other study ID #: EKNL
• Status: Not yet recruiting
• Start date: July 15, 2020
• Est. completion date: July 15, 2022

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: Enas Mohamed Sayed Ahmed
• Phone: 01004870406
• Email: enasmhmd05[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 67
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2021
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Petri M. Review of classification criteria for systemic lupus erythematosus. Rheum Dis Clin North Am. 2005 May;31(2):245-54, vi. Review. — View 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. — View 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. Erratum in: J Am Soc Nephrol. 2004 Mar;15(3):835-6. — View 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. Epub 2004 Nov 30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	correlation	relationship between Janus-kinase 3 expression and histopathological classification of renal biopsy in lupus nephritis proven patients	2 years
Primary	Janus-kinase 3 expression	evaluation of Janus-kinase 3 expression in blood and renal tissue of lupus patients during active stage of disease	within 2 years
Secondary	correlation	relationship between Janus- kinase expression and clinical and laboratory parameters of disease activity	2 years