VascERe
Vasculitis Egyptian Registry
Project Managers
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Prof. Medhat Shalaby
Al Azhar unveristy
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Prof. Amira Shahin
Cairo University
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Prof. Howaida Mansour
Ain Shams University
Objectives
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General Objective
Concerning the initial treatment of Vasculitis in daily practice this project proposes to describe the Egyptian daily clinical practice reality, delayed diagnosis, use/abuse of management recommendations, the unmet needs with DMARDs and immunosuppressive drugs.
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Specific Objectives
Primary objectives
in patients diagnosed with Vasculitis, the time between the diagnosis and the initiation of therapy, 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.
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Secondary objectives
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• Early diagnosis and start of DMARDs and/or immunosuppressive drugs.
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• To estimate the incidence and prevalence of GCA among Egyptian populations.
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• To estimate the incidence and prevalence of Takayasu’s arteritis among Egyptian populations.
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• To estimate the incidence and prevalence of Behcet’s syndrome among Egyptians.
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• To estimate the incidence and prevalence of Wegner Granulomatosis among Egyptians.
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• To estimate the incidence and prevalence of PAN among Egyptians.
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• To estimate the average time between the onset of symptoms and the first diagnosis.
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• To estimate the average time between diagnosis and the first dosage of treatment.
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• To estimate the average time between visits.
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• To estimate the frequency of patients who start the drug and failed to achieve remission.
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• To evaluate the frequency of adverse events to DMARDs.
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• 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)
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Demographic variable
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Serological subset
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Clinical settings (outpatient / hospital / center analysis)
Analysis plan
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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
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Analysis of secondary outcomes
Secondary outcomes will be estimated in a similar way to primary ones
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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.