A Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous (SC) Abatacept

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Adult RA patients followed up according to local clinical practice only at the hospital wards | |
| Cohort B<br>Adult RA patients followed up according to local clinical practice at the Hospital wards and additionally at their home through a support program | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of socio-demographic data | To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation | 24 months | 
| Patient Rheumatoid Arthritis History | To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation | 24 months | 
| Co-morbidities | To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation | 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 | 24 months | 
| Erythrocyte Sedimentation Rate | To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation | 24 months | 
| Rheumatoid Factor | To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation | 24 months | 
| Anti Citrullinated Peptide Antibody | To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation | 24 months | 
| Prior RA treatments | To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation | 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 | 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 | 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 | 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 | 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 | 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 | 24 months | 
| Adverse Events | To describe the incidence of Adverse Events, by seriousness and relationship with abatacept SC | 24 months | 
| Reason for Withdrawal, where applicable | To describe the incidence of the reasons for withdrawal from the treatment and the study | 24 months | 
| Retention rate | To evaluate the retention rate calculated as the time-to-discontinuation of abatacept SC treatment over the study observation period | 24 months | 
| Cost-utility analysis (CUA) | To perform a cost-utility analysis (CUA) from the National Health System | 24 months | 
| Societal perspective comparing health consequences | Societal perspective comparing health consequences Quality Adjusted Life Years (QALYs) | 24 months | 
| Cost of alternative follow-up strategies | Two alternative follow-up strategies: ESP versus standard control | 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 | 24 months |