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 (TIGHT)

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

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 Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 171

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25123
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult RA patients, 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 Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort A; Adult RA patients followed up according to local clinical practice only at the hospital wards
Cohort B; 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?

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Actual): August 24, 2020
• Study Completion (Actual): August 24, 2020

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: IM101-645