Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM

NCT03784547 | Unknown DMC FDA Drug

• 1 other identifier: RWD_Ocrelizumab LATAM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; Latin america

Outcome Measures

Primary Outcomes (2)

• 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

• Multiple sclerosis phenotype

  to describe the MS phenotype of patients that received ocrelizumab in LATAM

  12 months

Secondary Outcomes (2)

• Gender

  12 months

• Age at study entry

  12 months

Study Arms (1)

multiple sclerosis patients

multiple sclerosis patients receiving ocrelizumab 600 mg endovenous every 6 months

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

already described

Also known as: no other

multiple sclerosis patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients must meet the following inclusion criteria: MS patients who received ocrelizumab to treat their disease

You may qualify if:

• \- multiple sclerosis patients that received ocrelizumab

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (4)

Juan Ignacio Rojas

Buenos Aires, 1453, Argentina

NOT YET RECRUITING

Juan Ignacio Rojas

Buenos Aires, 1453, Argentina

COMPLETED

Juan Ignacio Rojas

Buenos Aires, 1453, Argentina

RECRUITING

Edgard Carnero

Buenos Aires, Argentina

COMPLETED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Juan I Rojas, MD

CONTACT

+5491169001957; juan.rojas@hiba.org.ar

Edgardo Cristiano, MD

CONTACT

00541149590200; cristiano.edgardo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 24, 2018
• Study Start: February 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (4)