The primary objective of this study is to investigate whether an Educational Supported Program (ESP), including tight control procedures implemented through patient home care, has positive impact in terms of better adherence to the therapy with abatacept SC at 12 months after treatment start (1st injection). In the scope of this objective the adherence is measured by the Medication Adherence Questionnaire (MAQ).
Study Type
OBSERVATIONAL
Enrollment
171
Local Institution
Brescia, Italy
Change in Medication Adherence Questionnaire (MAQ)
To investigate whether an Educational Support Program (ESP), including tight control procedures implemented through patient home care, has positive impact in terms of better adherence to the therapy with abatacept SC at 12 months and 24 months after treatment start (1st injection)
Time frame: 12 months and 24 months
Adherence ratio
Percentage ratio between the total number of injections taken in a treatment period and the total number of injections expected to be taken in the same treatment period according to rheumatologist prescription
Time frame: 24 months
Distribution of socio-demographic data
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Time frame: 24 months
Patient Rheumatoid Arthritis History
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Time frame: 24 months
Co-morbidities
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Time frame: 24 months
Clinical measurements (disease indices and relevant subcomponents)
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Time frame: 24 months
Erythrocyte Sedimentation Rate
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Time frame: 24 months
Rheumatoid Factor
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Time frame: 24 months
Anti Citrullinated Peptide Antibody
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Time frame: 24 months
Prior RA treatments
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Time frame: 24 months
Patient's reported assessment of health measured by HAQ-DI
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation and to investigate whether a better adherence to the abatacept SC therapy is associated to a better health status of the patient population
Time frame: 24 months
Health related quality of life measured by EQ-5D
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation and to investigate whether a better adherence to the abatacept SC therapy is associated to a better health status of the patient population
Time frame: 24 months
Remission rate measured by MAQ
To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population
Time frame: 24 months
Low disease activity rate measured by MAQ
To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population
Time frame: 24 months
DAS28 score measured by MAQ
To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population
Time frame: 24 months
Concomitant medication for RA (Synthetic DMARDs and corticosteroids)
To describe the use of concomitant medication for RA (Synthetic DMARDs and corticosteroids) over the study observation period
Time frame: 24 months
Adverse Events
To describe the incidence of Adverse Events, by seriousness and relationship with abatacept SC
Time frame: 24 months
Reason for Withdrawal, where applicable
To describe the incidence of the reasons for withdrawal from the treatment and the study
Time frame: 24 months
Retention rate
To evaluate the retention rate calculated as the time-to-discontinuation of abatacept SC treatment over the study observation period
Time frame: 24 months
Cost-utility analysis (CUA)
To perform a cost-utility analysis (CUA) from the National Health System
Time frame: 24 months
Societal perspective comparing health consequences
Societal perspective comparing health consequences Quality Adjusted Life Years (QALYs)
Time frame: 24 months
Cost of alternative follow-up strategies
Two alternative follow-up strategies: ESP versus standard control
Time frame: 24 months
Patient's reported assessment of health measured by Pain VAS
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation and to investigate whether a better adherence to the abatacept SC therapy is associated to a better health status of the patient population
Time frame: 24 months
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