Evaluation of Janus Kinase_3 in Juvenile Onset Systemic Lupus Erythematosus

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04293510
Collaborator
(none)
67
24

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: renal biopsy and blood sampling

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

Study Type:
Observational
Anticipated Enrollment :
67 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of Janus Kinase_3 Expression in Juvenile Onset Systemic Lupus Erythematosus
Anticipated Study Start Date :
Jul 15, 2020
Anticipated Primary Completion Date :
Jul 15, 2021
Anticipated Study Completion Date :
Jul 15, 2022

Arms and Interventions

Arm Intervention/Treatment
group study 1

children and adolescents who diagnosed as lupus patients

Procedure: renal biopsy and blood sampling
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

Outcome Measures

Primary Outcome Measures

  1. Janus-kinase 3 expression [within 2 years]

    evaluation of Janus-kinase 3 expression in blood and renal tissue of lupus patients during active stage of disease

Secondary Outcome Measures

  1. correlation [2 years]

    relationship between Janus- kinase expression and clinical and laboratory parameters of disease activity

Other Outcome Measures

  1. correlation [2 years]

    relationship between Janus-kinase 3 expression and histopathological classification of renal biopsy in lupus nephritis proven patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 16 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
enas mohamed sayed ahmed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04293510
Other Study ID Numbers:
  • EKNL
First Posted:
Mar 3, 2020
Last Update Posted:
Mar 4, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by enas mohamed sayed ahmed, Principal Investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2020