Multiple Sclerosis, Relapsing-Remitting
Conditions
Interventions
This is a cohort study with prospective data. The researcher will not perform any procedure and there will be no interference in the doctor's conduct. Data will be collected through an interview form
Sponsors
Universidade Federal de Mato Grosso do Sul
Universidade Federal de Mato Grosso do Sul
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Individuals over 18 years of age; of both sexes; diagnosed with Multiple Sclerosis represented by the G-35 code, which encompasses the group of diseases of the nervous system in the 10th edition of the International Statistical Classification of Diseases and Related Health Problems (ICD 10); assisted by the Specialized component of the Pharmaceutical Assistance of Mato Grosso do Sul; undergoing treatment, for at least three months, with one of the following oral administration medications: Teriflunomide 14mg, Dimethyl fumarate 240mg or Fingolimod 0.5mg; with at least one result of the Expanded Disability Status Scale (EDSS) prior to and one subsequent to the initiation of treatment with the oral medications described above
Exclusion criteria
Exclusion criteria: Individuals with cognitive alterations that make it difficult to remember facts related to their illness; individuals with cognitive alterations that make it difficult to understand the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to confirm the effectiveness of oral drugs that modify the course of the disease, verified by the annual rate of outbreaks, proportion of patients free of outbreaks, proportion of patients free of progression of neurological disability and proportion of patients free of radiological activity of the disease, based on the finding of p value <0.05 in the measurements of the first and second year of follow-up.;Outcome found 1: An increase in the annual outbreak rate was observed, verified by the Wilcoxon test, between the follow-up periods. No significant differences were observed in terms of the proportion of patients free of outbreaks, free of disability progression and free of radiological activity between the groups, verified by the Kruskal-Wallis test.;Expected outcome 2: It is expected to confirm the safety profile of oral disease-modifying drugs, verified from the identification of adverse reactions reported by the patient or documented in their medical health records, but without a necessary causal relationship with the drug.;Outcome found 2: No unexpected adverse reactions arose during the study. There were no hospitalizations or deaths related to treatment. The groups demonstrated similarity in relation to most of the reactions identified. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 3: It is expected to identify high levels of satisfaction with pharmacological treatment for multiple sclerosis, verified by applying the Medication Treatment Satisfaction Questionnaire©, based on the finding of scores above 80 points in biannual measurements.;Outcomes found 3: High levels of satisfaction with treatment were identified, verified by the Medication Treatment Satisfaction Questionnaire©, at all times evaluated. A significant increase in satisfaction scores attributed to the domains effectiveness (p68.0%), as assessed by the Morisky-Green Test and according to the ratio of medication possession, during the first and second year of follow-up.;Expected outcome 5: It is expected to find a low treatment discontinuation, verified by the ratio between the number of patients who discontinued therapy and the total number of patients being followed up, based on the finding of absence of medication dispensing within 90 consecutive days.;Outcome found 5: The treatment discontinuation rate was 37.4%. A lower discontinuation rate was demonstrated in patients using fingolimod. | — |
Countries
Brazil
Contacts
Public ContactCristiane Ferreira
Universidade Federal de Mato Grosso do Sul
Outcome results
None listed