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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03188081
Other study ID # IM101-645
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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