SCLERe
Scleroderma Egyptian Registry

Project Managers


  • Prof. Abdelazim Al Hefny
    Ain Shams University
  • Prof. Hesham Hamoud
    Al Azhar University
  • Prof. Fatma Noby
    Aswan University
  • Prof. Manal Hassanin
    Assuit University

Objectives

  • General Objective

      Concerning the initial treatment of Systemic sclerosis in daily practice this project proposes to describe the Egyptian daily clinical practice reality, delayed diagnosis, use/abuse of ACR/EULAR management recommendations, the unmet needs with DMARDs and the immunosuppressive drugs.

  • Specific Objectives:

      Primary objectives in patients diagnosed with SSc, the time between the diagnosis and the initiation of therapy with Conventional DMARDs, to assess the compliance with the EULAR /ACR and T2T recommendations of the initial phase of clinical management to assess the frequency of achievement of the 12 month target.

  • Secondary objectives

    • • Early diagnosis and start of any DMARDs or immunosuppressive drugs
    • • To estimate the incidence and prevalence of Diffuse SSc among Egyptian populations.
    • • To estimate the incidence and prevalence of Limited SSc among Egyptian populations.
    • • To estimate the average time between the onset of symptoms and the first diagnosis.
    • • To estimate the average time between diagnosis and the first dosage of treatment.
    • • To estimate the average time between visits.
    • • To estimate the frequency of patients who start the drug and failed to achieve remission.
    • • To estimate the frequency of prescription of different biological drugs after the failure of
    • • To evaluate the frequency of adverse events to DMARDs.
    • • To evaluate the frequency of adverse events to Immunosuppressive drugs.

Study design

  Mixed cohort study. Prospective Study & Retrospective Study

Recruitment centers:

  All rheumatology departments among the Egyptian universities, in addition to some of the potential rheumatology private clinics will have a unique username and password to login and add his last recruitment patients: Consecutive patients. Recruitment 18 months. Minimum 12 month follow-up (First patient assessed: 30 months) study.

Factors of interest (exposure variables)

  • Demographic variable
  • Serological subset
  • Clinical settings (outpatient / hospital / center analysis)

Analysis plan

  • Analysis of the primary outcome

      Primary outcomes will be estimated as a mean therapeutic delay and as a probability (risk) of achievement of the target / or adherence to recommendations and 95% confidence intervals

  • Analysis of secondary outcomes

      Secondary outcomes will be estimated in a similar way to primary ones

  • Explorative analysis

      The influence of demographic, clinical (serological), therapeutic factors (association with glucocorticoids), organizational (setting), pathway (time to referral, to diagnosis ,to treatment) on the variables of longitudinal outcome (target achievement, treatment survival, adverse events, biological switch) will be explored using regression models appropriate to type of outcome variable.

Project timeline 2018/19 – 2024

# 2018 - 2019 2020 2021 2022 2023 2024
Design & Protocol
Recruitment Centers
Recruitment Doctors
Follow up
Monitoring
Data Cleaning
Analysis
Publication

List Of Cases

New Case

# Date Patient Doctor Site
93254 7/5/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43263 3/19/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43321 3/14/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43246 3/13/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43319 3/13/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43320 3/12/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43203 2/28/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43202 2/28/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43198 2/23/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43197 2/23/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43196 2/23/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43194 2/21/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43193 2/21/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43187 2/20/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43169 2/16/2019 New Patient Prof. Hesham Hamoud Al Azhar University Hospitals BOYS (CAIRO)
43192 2/7/2019 New Patient Prof. Sherif Refaat Al Azhar University Hospitals BOYS (CAIRO)
43191 2/7/2019 New Patient Prof. Sherif Refaat Al Azhar University Hospitals BOYS (CAIRO)

List Of Doctors