NCT04234633

Brief Summary

The investigators aim to compare the clinical characteristics and outcomes of SLE between male and female Egyptian patients at Assuit University Hospital.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 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

January 11, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 11, 2020

Last Update Submit

January 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presentation, complication, and mortality among males and female patients with SLE

    Using percentages, we will track the number of patients that develop certain clinical conditions (such as arthritis, malar rash, .... ), complications (such as nephritis), and mortality rates. These numbers and percentages will be used to compare males with females (incidence rates for each event will be calculated).

    2 years

Study Arms (1)

SLE patients

Any SLE patients between 18 and 40 years old.

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Any SLE patients between 18and 40 years old will be eligible to be included in our study.

You may qualify if:

  • Any SLE patients between 18and 40 years old will be eligible to be included in our study.

You may not qualify if:

  • Patients below the age of 18 or above 40.
  • Any other autoimmune disease.
  • Cardiovascular, neurological, renal complications due to other co-morbidity such as DM and HTN.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Mok CC, Lau CS, Chan TM, Wong RW. Clinical characteristics and outcome of southern Chinese males with systemic lupus erythematosus. Lupus. 1999;8(3):188-96. doi: 10.1191/096120399678847605.

  • Soto ME, Vallejo M, Guillen F, Simon JA, Arena E, Reyes PA. Gender impact in systemic lupus erythematosus. Clin Exp Rheumatol. 2004 Nov-Dec;22(6):713-21.

  • El Hadidi KT, Medhat BM, Abdel Baki NM, Abdel Kafy H, Abdelrahaman W, Yousri AY, Attia DH, Eissa M, El Dessouki D, Elgazzar I, Elgengehy FT, El Ghobashy N, El Hadary H, El Mardenly G, El Naggar H, El Nahas AM, El Refai RM, El Rwiny HA, Elsman RM, Galal M, Ghoniem S, Maged LA, Sally SM, Naji H, Saad S, Shaaban M, Sharaf M, Sobhy N, Soliman RM, El Hadidi TS. Characteristics of systemic lupus erythematosus in a sample of the Egyptian population: a retrospective cohort of 1109 patients from a single center. Lupus. 2018 May;27(6):1030-1038. doi: 10.1177/0961203317751856. Epub 2018 Feb 10.

Study Officials

  • Ahmed Aeltaih, MBBch

    Assuit University Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Aeltaih, MBBch

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 11, 2020

First Posted

January 21, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

January 21, 2020

Record last verified: 2020-01