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Multiple Sclerosis Registry in Argentina (RelevarEM) (RelevarEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03375177
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : August 6, 2019
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

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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)
Actual Study Start Date : March 25, 2018
Estimated Primary Completion Date : July 16, 2021
Estimated Study Completion Date : June 23, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT03375177

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Contact: Juan I Rojas, MD 541149590200 ext 4512

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Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina, 1411
Contact: Juan I Rojas, MD, MSc    541149590200 ext 4512   
Contact: Edgardo Cristiano, MD    541149590200 ext 4512   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Additional Information:
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.

Publications automatically indexed to this study by Identifier (NCT Number):
Kohler M, Kohler E, Vrech C, Pappolla A, Miguez J, Patrucco L, Correale J, Marrodan M, Gaitán MI, Fiol M, Negrotto L, Ysrraelit MC, Cristiano E, Carrá A, Steinberg J, Martinez AD, Curbelo MC, Cohen L, Alonso R, Garcea O, Pita C, Silva B, Luetic G, Deri N, Balbuena ME, Tkachuk V, Carnero Contentti E, Lopez PA, Pettinicchi JP, Caride A, Burgos M, Leguizamon F, Knorre E, Piedrabuena R, Barboza A, Liwacki S, Nofal P, Volman G, Alvez Pinheiro A, Hryb J, Tavolini D, Blaya P, Recchia L, Mainella C, Silva E, Blanche J, Tizio S, Saladino ML, Caceres F, Fernandez Liguori N, Lazaro L, Zanga G, Parada Marcilla M, Fracaro ME, Pagani Cassara F, Vazquez G, Sinay V, Sgrilli G, Divi P, Jacobo M, Reich E, Cabrera LM, Menichini ML, Coppola M, Martos I, Viglione JP, Jose G, Bestoso S, Manzi R, Giunta D, Doldan ML, Alonso Serena M, Rojas JI. Aggressive multiple sclerosis in Argentina: Data from the nationwide registry RelevarEM. J Clin Neurosci. 2021 Jul;89:360-364. doi: 10.1016/j.jocn.2021.05.047. Epub 2021 Jun 1.
Rojas JI, Alonso Serena M, Garcea O, Patrucco L, Carrá A, Correale J, Vrech C, Pappolla A, Miguez J, Doldan ML, Silveira F, Alonso R, Cohen L, Pita C, Silva BA, Fiol M, Gaitán MI, Marrodan M, Negrotto L, Ysrraelit MC, Deri N, Luetic G, Caride A, Carnero Contentti E, Lopez PA, Pettinicchi JP, Curbelo C, Martinez AD, Steinberg JD, Balbuena ME, Tkachuk V, Burgos M, Knorre E, Leguizamon F, Piedrabuena R, Liwacki SDV, Barboza AG, Nofal P, Volman G, Alvez Pinheiro A, Hryb J, Tavolini D, Blaya PA, Silva E, Blanche J, Tizio S, Caceres F, Saladino ML, Zanga G, Fracaro ME, Sgrilli G, Pagani Cassara F, Vazquez G, Sinay V, Menichini ML, Lazaro L, Cabrera LM, Bestoso S, Divi P, Jacobo M, Kohler E, Kohler M, Giunta D, Mainella C, Manzi R, Parada Marcilla M, Viglione JP, Martos I, Reich E, Jose G, Cristiano E, Fernández Liguori N; on behalf RelevarEM investigators. Multiple sclerosis and neuromyelitis optica spectrum disorders in Argentina: comparing baseline data from the Argentinean MS Registry (RelevarEM). Neurol Sci. 2020 Jun;41(6):1513-1519. doi: 10.1007/s10072-019-04230-6. Epub 2020 Jan 20.

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Responsible Party: Juan Igancio Rojas, MD, Hospital Italiano de Buenos Aires Identifier: NCT03375177    
Other Study ID Numbers: 3312
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

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