Multiple Sclerosis Registry in Argentina (RelevarEM) (RelevarEM)
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|ClinicalTrials.gov Identifier: NCT03375177|
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : August 6, 2019
|First Submitted Date||December 7, 2017|
|First Posted Date||December 15, 2017|
|Last Update Posted Date||August 6, 2019|
|Actual Study Start Date||March 25, 2018|
|Estimated Primary Completion Date||July 16, 2021 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures
||Demographic outcomes [ Time Frame: 2 years ]
age and sex of MS patients registered
|Original Primary Outcome Measures||Same as current|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Multiple Sclerosis Registry in Argentina (RelevarEM)|
|Official Title||Multiple Sclerosis Registry in Argentina (RelevarEM)|
|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.|
Multiple sclerosis (MS) is a chronic degenerative disease of autoimmune etiology that affects young adults between 18 and 35 years of age, being the first cause of physical disability of non-traumatic origin in several countries of the world.
MS is characterized histopathologically by the presence of inflammatory plaques in the white matter associated with the presence of axonal damage. Clinically, four evolutionary courses can be distinguished from the disease: a form in which inflammatory outbreaks occur that affect the brain and that the patient refers to as relapses and remissions (RRMS). This form, in most cases and after years of evolution, enters a sustained progression of the disability known as secondary progressive phase (SPMS) being another clinical form of the disease. In a smaller percentage of patients, the disease may have a progressive course from the beginning with the presence of some interposed outbreaks, a form known as progressive with relapses (PRMS), and finally the fourth form of presentation of the disease may be manifest with progression of disability from the outset without originating outbreaks in the course of the same known as primary progressive form (PPMS).
South America is a low-middle risk area for MS with a reported prevalence of between 1.48 and 36 cases per 100,000 population. The cause of observed differences in disease frequency between Europe and North America relative to South America is unknown to date. It is suggested that genetic predisposition would mainly contribute to the geographical variation in the prevalence of MS; however, this factor alone can not explain the overall differences in risk between populations.
The frequency and distribution of this condition has been described in several parts of the world, but it is still necessary to identify it more precisely in the countries and regions of South America.
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 MS 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.
It is important to mention that the data to be collected are part of the data of the daily clinical practice without implying for the patient or the doctor additional work as well as unnecessary procedures.
Objectives Primary objective The creation of a national registry system for MS patients with retrospective and prospective survey of epidemiological, diagnostic, prognostic, treatment, follow-up and survival data.
Methods The project aims to be a strictly observational longitudinal record, which will follow the results of the usual clinical practice for patients with MS. There will be no experimental interventions in the registry.
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.
1. Patients who meet the diagnostic criteria for MS according to validated criteria.
Design The registry behaves as a cohort study, with sample capture of prevalent cases and consecutive incident cases.
Data collection Sample Two consecutive strategies are proposed for the inclusion of the largest random sample of prevalent cases and all incident cases.
Once the patient is identified and consented to participate, the requested data will be entered into a collection platform specifically designed for this purpose. The platform on which the registry will be used will be a web platform with restricted access by user and password specific to each researcher. The registers entered will be displayed only by the investigator (personal register) and once the same one wishes, it will be able to share the registry with the global base (central registry) to carry out global communications. When sharing the registry, it will be anonymised and only data related to the demographics and clinic will be accessible, and patient data such as name, surname will not be visible to analysts if it is loaded.
Variables to be collected
Variables to be analyzed to evaluate the objectives of the project are:
6- Expanded disability status scale (EDSS) 7. Initial therapy used. 8. Clinical and radiological activity during follow-up: presence of new relapses during clinical follow-up and / or new MRI lesions and EDSS.
9. Specific treatment changes for the disease during follow-up 10. Reasons for change of treatment 11. Evolution to secondary progressive forms of the disease 12. Safety issues during follow up
Statistical analysis plan This is an open-ended Registry, and sample size is not based on statistical considerations. A descriptive analysis is the main objective of the registry regarding demographic, clinical aspects, disease activity and safety issues at registry entry and during the follow up. Statistical analyses will be performed on clinical parameters such as relapse and disability outcomes, included in the minimum dataset. Analyses may also be performed on other parameters included in the uploaded datasets.
Data protection The regulatory requirements and protection of personal data must be completed according to the regulations corresponding to each participant.
Each researcher in the registry should explain in detail to each potential participant the record consists of and should provide the possibility to ask questions that will be answered in a timely manner. Every patient who wishes to participate in the registry must consent, according to each regulation, authorizing that their information, codified and anonymized, be shared with other records for analysis and communication.
An institutional ethics committee must approve the registration or declare that it is exempt from the need for approval as well as its informed consent.
The data will be uploaded by the principal investigators of each participating center. The different variables to be collected will be obtained from the daily clinical practice of each professional.
Patient Confidentiality As mentioned in the previous point, the patient's name, address, date of birth, or telephone number will only be left in the personal registry and at the moment of sharing the registration to the central registry will not be entered. The records will then be identified by a unique code generated by the initials of the investigator and the registration number of that patient.
At all times, the protection of the patient's identity and data will be observed in accordance with the legal regulations in force national law of protection of personal data 25.326 (Habeas Data), in accordance with the international legislation on registration of diseases and protection of personal data and private, according to the 18th World Medical Assembly of Helsinki (1964) when applicable. The right to non-participation in the registry will be respected at all times without this implying in any case any type of discrimination, differential treatment or mistreatment towards the patient.
Exclusion of registration If, at any point in time, the patient or the investigator decides to withdraw the registration of certain patients from the central registry, they may be excluded from future submissions of information to the central registry. The information previously incorporated in the decision to withdraw the registration of the central registry will remain in the same. In case the investigator wants to withdraw its participation in the registry, it should be notified one month in advance to the scientific advisory committee. The information previously uploaded to the central registry will be removed from the analysis as well as future communications.
|Study Type||Observational [Patient Registry]|
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||8 Years|
|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.|
|Intervention||Other: Natural history of disease
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment||Same as current|
|Estimated Study Completion Date||June 23, 2024|
|Estimated Primary Completion Date||July 16, 2021 (Final data collection date for primary outcome measure)|
Patients who do not meet the criteria of MS Patients who decide not to participate in the registry.
|Ages||Child, Adult, Older Adult|
|Accepts Healthy Volunteers||No|
|Listed Location Countries||Argentina|
|Removed Location Countries|
|Other Study ID Numbers||3312|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||
|Responsible Party||Juan Igancio Rojas, Hospital Italiano de Buenos Aires|
|Study Sponsor||Hospital Italiano de Buenos Aires|
|PRS Account||Hospital Italiano de Buenos Aires|
|Verification Date||July 2019|