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

Rheumatoid Arthritis Clinical Trial

— TIGHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188081
• Other study ID #: IM101-645
• Status: Completed
• Start date: August 2, 2017
• Est. completion date: August 24, 2020

Study information

• Verified date: June 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: August 24, 2020
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Italy	Local Institution	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Italy, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls