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Multiple Sclerosis Registry in Argentina (RelevarEM) (RelevarEM)

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ClinicalTrials.gov Identifier: NCT03375177
Recruitment Status : Not yet recruiting
First Posted : December 15, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Juan Igancio Rojas, Hospital Italiano de Buenos Aires

Brief Summary:
The main reason for RelevarEM project is the creation of a registry based on a web platform to facilitate the collection of epidemiological data of multiple sclerosis patients from multiple sources in Argentina. The platform will provide the data in a global way that will show the frequency and distribution of the disease in our environment at low cost.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Natural history of disease

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Years
Official Title: Multiple Sclerosis Registry in Argentina (RelevarEM)
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Natural history of disease
    registry plan


Primary Outcome Measures :
  1. Demographic outcomes [ Time Frame: 2 years ]
    age and sex of MS patients registered



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
Any patient diagnosed with MS can be entered into the registry. In order to reduce the possibility of bias in the selection, it is sought to include all the patients with MS that are in follow-up or so considered by each participant or researcher.
Criteria

Inclusion Criteria:

  • 1. Patients who meet the diagnostic criteria for MS according to validated criteria

Exclusion Criteria:

Patients who do not meet the criteria of MS Patients who decide not to participate in the registry.


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): NCT03375177


Contacts
Contact: Juan I Rojas, MD 541149590200 ext 4512 juan.rojas@hospitalitaliano.org.ar

Locations
Argentina
Hospital Italiano de Buenos Aires Not yet recruiting
Buenos Aires, Argentina, 1411
Contact: Juan I Rojas, MD, MSc    541149590200 ext 4512    juan.rojas@hospitalitaliano.org.ar   
Contact: Edgardo Cristiano, MD    541149590200 ext 4512    edgardo.cristiano@hiba.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires

Additional Information:
Publications:
Noseworthy, J.H., et al., Multiple sclerosis. N Engl J Med, 2000. 343(13): p. 938-52. 2. Lublin, F.D. and S.C. Reingold, Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis. Neurology, 1996. 46(4): p. 907-11. 3. Cristiano, E., L. Patrucco, and J.I. Rojas, A systematic review of the epidemiology of multiple sclerosis in South America. Eur J Neurol, 2008. 15(12): p. 1273-8. 4. Ebers, G.C., Environmental factors and multiple sclerosis. Lancet Neurol, 2008. 7(3): p. 268-77. 5. Patrucco, L., et al., HLA-DRB1 and multiple sclerosis in Argentina. Eur J Neurol, 2009. 16(3): p. 427-9. 6. Pittock, S.J., et al., Seroprevalence of aquaporin-4-IgG in a northern California population representative cohort of multiple sclerosis. JAMA Neurol, 2014. 71(11): p. 1433-6. 7. Polman, C.H., et al., Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol, 2011. 69(2): p. 292-302.

Responsible Party: Juan Igancio Rojas, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT03375177     History of Changes
Other Study ID Numbers: 3312
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juan Igancio Rojas, Hospital Italiano de Buenos Aires:
multiple sclerosis
Argentina
epidemiology
registry

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases