Quality of life
Conditions
Interventions
Participants will be divided into groups according to the use of medication for Multiple Sclerosis. The unexposed group will consist of 35 individuals whose first sclerosis treatment was natalizumab.
D12.776.124.486.485.114.224.060.813
Sponsors
Faculdade de Ciências Farmacêuticas, Alimentos e Nutrição da Universidade Federal de Mato Grosso do Sul
Faculdade de Ciências Farmacêuticas, Alimentos e Nutrição da Universidade Federal de Mato Grosso do Sul
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients diagnosed with Multiple Sclerosis, according to the 10th edition of the International Code of Diseases (ICD 10), classified as G35, diagnosed according to revised and adapted McDonalds criteria will be included in the research; of both sexes; aged over 18 years; who have been on natalizumab treatment for at least 3 months, presenting at least one Expanded Disability Status Scale (EDSS) assessment prior to the use of natalizumab and a subsequent assessment
Exclusion criteria
Exclusion criteria: Individuals with cognitive alterations that make it difficult to remember facts related to their disease and to understand the research will be excluded, as well as those who do not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expect outcome 1, evaluate the clinical effectiveness of natalizumab in patients with multiple sclerosis by checking the annualized relapse rate, presence of neurological disability progression, rate of disease progression, presence of new lesions in brain and spinal ressonance. ;Outcome found 1, During the follow-up period, four outbreak episodes were recorded. When considering the total cohort, the annualized rate of relapse during the follow-up period corresponded to 0.09±0.374, the proportion of patients without relapses was 93.5% and 81.7% had no worsening in EDSS. Furthermore, 83.3% were free of radiological alterations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expect outcome 2, analyze the safety profile by reporting and recording adverse events. The presence of alterations in the laboratory profile, infections, hepatic, gastrointestinal, cardiac, neurological, visual and generalized complaints will be considered adverse effects.;Expect outcome 3, analyzing individuals' satisfaction with natalizumab treatment for multiple sclerosis will be determined by applying the Brazilian version of the Treatment Satisfaction Questionnaire for Medication instrument. This instrument has cross-cultural translation and validation into Portuguese, consisting of a survey of 11 questions distributed in four domains effectiveness, side effects, convenience, overall satisfaction and will be applied as part of the interview to facilitate the participants' understanding of the questions. The score varies from 0 to 100 in each domain and will be calculated as recommended by the authors of the instrument.;Expect outcome 4,to analyze the quality of life of individuals being treated with natalizumab using the Multiple Sclerosis Quality of Life questionnaire 54. This instrument has a cross cultural translation and validation in Portuguese and is composed of 54 questions, with 52 items grouped into 12 subscales and two distinct questions dealing with the change in health status and the patient's assessment of satisfaction with sexual . ;Outcome found 2, regarding the safety of the medication, 51 patients (85.3%) reported at least one adverse reaction, totaling 104 reactions. Respiratory infections were the most frequent among patients. It is important to report that no participant presented progressive multifocal leukoencephalopathy and no unexpected reactions were identified during the study period. ;Outcome found 3, high satisfaction rates above 80% were identified in relation to effectiveness, side effects, convenience and overall satisfaction with drug treatment according to the TSQM instrument.;Outcome found 4, quality of life, in the emotiona | — |
Countries
Brazil
Contacts
Public ContactErica Pereira
Universidade Federal de Mato Grosso do Sul
Outcome results
None listed