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)

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT03188081

IM101-645

Details and patient eligibility

About

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).

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

171 participants in 2 patient groups

Cohort A

Description:

Adult RA patients followed up according to local clinical practice only at the hospital wards

Cohort B

Description:

Adult RA patients followed up according to local clinical practice at the Hospital wards and additionally at their home through a support program