NCT04293510

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

February 29, 2020

Last Update Submit

March 3, 2020

Conditions

Systemic Lupus Erythematosus

Keywords

Janus-kinase3activelupus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • correlation

    2 years

Other Outcomes (1)

  • correlation

    2 years

Study Arms (2)

group study 1

children and adolescents who diagnosed as lupus patients

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

Interventions

renal biopsy and blood samplingPROCEDURE

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

group study 1

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Age younger than 16 years.
  • Active disease stage
  • Patients with biopsy proven lupus nephritis according to ISN/RPS classification criteria of lupus nephritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 15575979BACKGROUND

  • 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.

    PMID: 17804842BACKGROUND

  • 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.

    PMID: 14747370BACKGROUND

  • 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.

    PMID: 15922144BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

frozen renal tissue and whole blood

MeSH Terms

Conditions

Lupus Erythematosus, SystemicMotor Activity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Enas Mohamed Sayed Ahmed

CONTACT

01004870406enasmhmd05@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 29, 2020

First Posted

March 3, 2020

Study Start

July 15, 2020

Primary Completion

July 15, 2021

Study Completion

July 15, 2022

Last Updated

March 4, 2020

Record last verified: 2020-03