Clinical trial NCT03188081: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-15
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Medication Adherence Questionnaire (MAQ)
timeFrame: 12 months and 24 months
measure: Adherence ratio
timeFrame: 24 months
Secondary outcomes:
measure: Distribution of socio-demographic data
timeFrame: 24 months
measure: Patient Rheumatoid Arthritis History
timeFrame: 24 months
measure: Co-morbidities
timeFrame: 24 months
measure: Clinical measurements (disease indices and relevant subcomponents)
timeFrame: 24 months
measure: Erythrocyte Sedimentation Rate
timeFrame: 24 months
measure: Rheumatoid Factor
timeFrame: 24 months
measure: Anti Citrullinated Peptide Antibody
timeFrame: 24 months
measure: Prior RA treatments
timeFrame: 24 months
measure: Patient's reported assessment of health measured by HAQ-DI
timeFrame: 24 months
measure: Health related quality of life measured by EQ-5D
timeFrame: 24 months
measure: Remission rate measured by MAQ
timeFrame: 24 months
measure: Low disease activity rate measured by MAQ
timeFrame: 24 months
measure: DAS28 score measured by MAQ
timeFrame: 24 months
measure: Concomitant medication for RA (Synthetic DMARDs and corticosteroids)
timeFrame: 24 months
measure: Adverse Events
timeFrame: 24 months
measure: Reason for Withdrawal, where applicable
timeFrame: 24 months
measure: Retention rate
timeFrame: 24 months
measure: Cost-utility analysis (CUA)
timeFrame: 24 months
measure: Societal perspective comparing health consequences
timeFrame: 24 months
measure: Cost of alternative follow-up strategies
timeFrame: 24 months
measure: Patient's reported assessment of health measured by Pain VAS
timeFrame: 24 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: