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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03188081
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-15
• Study Start: 2017-08-02
• Primary Completion: 2020-08-24
• Study Completion: 2020-08-24
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

Read More

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)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence ratio	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)	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 Outcome Measures

Name	Time	Method
Rheumatoid Factor	24 months	To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Anti Citrullinated Peptide Antibody	24 months	To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Patient Rheumatoid Arthritis History	24 months	To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Erythrocyte Sedimentation Rate	24 months	To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Clinical measurements (disease indices and relevant subcomponents)	24 months	To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Co-morbidities	24 months	To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Reason for Withdrawal, where applicable	24 months	To describe the incidence of the reasons for withdrawal from the treatment and the study
Low disease activity rate measured by MAQ	24 months	To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population
Patient's reported assessment of health measured by Pain VAS	24 months	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
Retention rate	24 months	To evaluate the retention rate calculated as the time-to-discontinuation of abatacept SC treatment over the study observation period
DAS28 score measured by MAQ	24 months	To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population
Patient's reported assessment of health measured by HAQ-DI	24 months	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
Health related quality of life measured by EQ-5D	24 months	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
Remission rate measured by MAQ	24 months	To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population
Concomitant medication for RA (Synthetic DMARDs and corticosteroids)	24 months	To describe the use of concomitant medication for RA (Synthetic DMARDs and corticosteroids) over the study observation period
Distribution of socio-demographic data	24 months	To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Prior RA treatments	24 months	To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Adverse Events	24 months	To describe the incidence of Adverse Events, by seriousness and relationship with abatacept SC
Societal perspective comparing health consequences	24 months	Societal perspective comparing health consequences Quality Adjusted Life Years (QALYs)
Cost-utility analysis (CUA)	24 months	To perform a cost-utility analysis (CUA) from the National Health System
Cost of alternative follow-up strategies	24 months	Two alternative follow-up strategies: ESP versus standard control

Trial Locations

Locations (1)

Local Institution; 🇮🇹 Brescia, Italy