A Prospective, Multicentric, Observational Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life RA Patients Treated With Abatacept SC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- Adherence ratio
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent to participate in the study signed by the patient
- •Age ≥ 18 years at the date of consent subscription
- •Diagnosis of active Rheumatoid Arthritis moderate to severe as per the 1987 American College of Rheumatology (ACR) criteria/2010 ACR/ European League Against Rheumatism (EULAR) RA Classification Criteria
- •Naïve of abatacept
- •Initiated with abatacept SC either as 1st or 2nd line biologic treatment after inadequate response to previous therapy with one or more DMARDs according to Summary of Product Characteristics (SmPC) locally approved
Exclusion Criteria
- •Participating in clinical trial or other non-interventional studies, excluding registries
- •Inability to read and write
- •Any condition that in the investigator's opinion might jeopardize the follow-up and the data collection for the entire study observation period (24 months)
Outcomes
Primary Outcomes
Adherence ratio
Time Frame: 24 months
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
Change in Medication Adherence Questionnaire (MAQ)
Time Frame: 12 months and 24 months
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)
Secondary Outcomes
- Erythrocyte Sedimentation Rate(24 months)
- Rheumatoid Factor(24 months)
- Anti Citrullinated Peptide Antibody(24 months)
- Clinical measurements (disease indices and relevant subcomponents)(24 months)
- Co-morbidities(24 months)
- Patient Rheumatoid Arthritis History(24 months)
- Low disease activity rate measured by MAQ(24 months)
- Patient's reported assessment of health measured by Pain VAS(24 months)
- Patient's reported assessment of health measured by HAQ-DI(24 months)
- Health related quality of life measured by EQ-5D(24 months)
- Remission rate measured by MAQ(24 months)
- Concomitant medication for RA (Synthetic DMARDs and corticosteroids)(24 months)
- Distribution of socio-demographic data(24 months)
- Prior RA treatments(24 months)
- DAS28 score measured by MAQ(24 months)
- Adverse Events(24 months)
- Reason for Withdrawal, where applicable(24 months)
- Retention rate(24 months)
- Societal perspective comparing health consequences(24 months)
- Cost-utility analysis (CUA)(24 months)
- Cost of alternative follow-up strategies(24 months)