Multiple Sclerosis Clinical Trial
Official title:
Multiple Sclerosis Registry in Argentina (RelevarEM)
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.
Inclusion criteria
1. Patients who meet the diagnostic criteria for MS according to validated criteria.
Exclusion criteria
1. Patients who do not meet the criteria of MS
2. Patients who decide not to participate in the registry.
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:
1. Demographic: age, sex, place of residence at the time of onset of the disease and at the
time of entry to the registry
2. Administrative: type of current medical coverage
3. Baseline characteristics: Comorbidities, year of diagnosis, complementary studies made
for that diagnosis and treatment used for comorbidity.
4. Disease activity prior to admission to the registry: date and number of previous
relapses and location of relapses.
5. Clinical presentation: characteristics of the first symptom, functional system affected,
recovery of that first symptom, systems affected, recovery of that first relapse and
findings of resonance (performed with the first clinical episode).
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.
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