Multiple Sclerosis Clinical Trial
— RWD_ocreOfficial title:
Real-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin America
It has been almost 25 years since the publication of the pivotal trial results for the first
disease-modifying therapy (DMT) for RRMS. Currently disease modifying therapies (DMTs) for MS
approved by the European Medicine Agency (EMA) and Food and Drug Administration (FDA) include
interferon beta (IFNβ) 1-a and 1-b, glatiramer acetate (GA), mitoxantrone, natalizumab,
fingolimod, teriflunomide, dimethyl fumarate, alemtuzumab, daclizumab and ocrelizumab.
Despite evidence about ocrelizumab exist in many patients from eurpe and North America,
scarce real world evidence exists about epidemiolofcal aspects of patients that used
ocrelizumab in Latin America.
The aim of this study is therefore to evaluate patient profiles and persistence to treatment
during follow up in a retrospective study of patients who had been prescribed ocrelizumab for
the treatment of MS in Latin America (LATAM). The investigators will include MS patients that
received ocrelizumab in Latin America and describe epidemiological aspects and persistence to
treatment during the last 12 months.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - multiple sclerosis patients that received ocrelizumab Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Argentina | Edgard Carnero | Buenos Aires | |
Argentina | Juan Ignacio Rojas | Buenos Aires | |
Argentina | Juan Ignacio Rojas | Buenos Aires | |
Argentina | Juan Ignacio Rojas | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Hospital Italiano de Buenos Aires |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients discontinuing the treatment with ocrelizumab in the last 12 months after inclusion | To describe the number of patients that discontinue the use of ocrelizumab during the last 12 months | 12 months | |
Primary | Multiple sclerosis phenotype | to describe the MS phenotype of patients that received ocrelizumab in LATAM | 12 months | |
Secondary | Gender | to describe the gender of patients that received ocrelizumab in LATAM | 12 months | |
Secondary | Age at study entry | To describe the age of patients that received ocrelizumab at study entry | 12 months |
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