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Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM (RWD_ocre)

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ClinicalTrials.gov Identifier: NCT03784547
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Italiano de Buenos Aires

Brief Summary:

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.


Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Ocrelizumab

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin America
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Group/Cohort Intervention/treatment
multiple sclerosis patients
multiple sclerosis patients receiving ocrelizumab 600 mg endovenous every 6 months
Drug: Ocrelizumab
already described
Other Name: no other




Primary Outcome Measures :
  1. Proportion of patients discontinuing the treatment with ocrelizumab in the last 12 months after inclusion [ Time Frame: 12 months ]
    To describe the number of patients that discontinue the use of ocrelizumab during the last 12 months

  2. Multiple sclerosis phenotype [ Time Frame: 12 months ]
    to describe the MS phenotype of patients that received ocrelizumab in LATAM


Secondary Outcome Measures :
  1. Gender [ Time Frame: 12 months ]
    to describe the gender of patients that received ocrelizumab in LATAM

  2. Age at study entry [ Time Frame: 12 months ]
    To describe the age of patients that received ocrelizumab at study entry



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients must meet the following inclusion criteria:

MS patients who received ocrelizumab to treat their disease

Criteria

Inclusion Criteria:

- multiple sclerosis patients that received ocrelizumab

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784547


Contacts
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Contact: Juan I Rojas, MD +5491169001957 juan.rojas@hiba.org.ar
Contact: Edgardo Cristiano, MD 00541149590200 cristiano.edgardo@gmail.com

Locations
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Argentina
Juan Ignacio Rojas Not yet recruiting
Buenos Aires, Argentina, 1453
Contact: Juan I Rojas    91169001957    juan.rojas@hiba.org.ar   
Juan Ignacio Rojas Completed
Buenos Aires, Argentina, 1453
Juan Ignacio Rojas Recruiting
Buenos Aires, Argentina, 1453
Contact: Juan I Rojas    +5491169001957    rojasjuanignacio@gmail.com   
Principal Investigator: Edgar Carnero, MD         
Edgard Carnero Completed
Buenos Aires, Argentina
Sponsors and Collaborators
Hospital Italiano de Buenos Aires

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Responsible Party: Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT03784547     History of Changes
Other Study ID Numbers: RWD_Ocrelizumab LATAM
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Italiano de Buenos Aires:
multiple sclerosis
Latin america
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs