Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

Detailed Description
-----------------
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review

Official Title
-----------------
Evaluation of the Effectiveness of the Abatacept (Orencia®) IV and SC Patient Alert Cards in Patients With Rheumatoid Arthritis in European Economic Area Countries

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient survey (cohort 1): Patients has taken abatacept within the previous 3 months for rheumatoid arthritis Patient is 18 years of age or over HCP survey (cohort 2): a) Physician or nurses working in rheumatology centers, with at least 1 patient taking abatacept in the previous 6 months for rheumatoid arthritis (by prescribing, administering or by follow up) Retrospective chart review study (cohort 3): Patient survey questionnaire completed , Informed Consent Form (ICF) signed Exclusion Criteria: Patient survey: Patient has participated in a clinical trial for their arthritis in the previous 12 months Currently an employee of BMS HCP survey: Physicians or nurse who have recruited patients for the Patient survey Currently an employee of BMS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients survey<br>Adult patients treated with abatacept for rheumatoid arthritis | |
| HCP survey<br>HCP with at least 1 patient taking abatacept | |
| Retrospective chart review study<br>Adult patients treated with abatacept for rheumatoid arthritis | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC |  | At patient enrolment | 
| Patient survey: Proportion of patients treated with abatacept who have received the PAC |  | At patient enrolment | 
| Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use |  | At patient enrolment | 
| Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment |  | At patient enrolment | 
| Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment |  | At patient enrolment | 
| Patient survey: Mean scores for correct responses for questions grouped by objectives | Objectives: distribution, awareness, utility, utilization and knowledge | At patient enrolment | 
| Patient survey: Mean total score for correct responses |  | At patient enrolment | 
| HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC |  | Day 1 | 
| HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use |  | Day 1 | 
| HCP survey: Levels of HCPs' knowledge and comprehension related to the important identified risks of infections and the need to screen for specific infection prior to initiating or administering abatacept |  | Day 1 | 
| HCP survey: Mean total score for correct responses |  | Day 1 | 
| HCP survey: Mean scores for correct responses for questions grouped by objectives | Objectives: distribution, awareness, utility, utilization and knowledge | Day 1 | 
| Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization |  | Approximately 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients | Determinants: Formulation of abatacept administered, country, age, gender, educational level, duration of arthritis, number of prescription medications, duration of therapy with abatacept, HCP guided or self-administration | At patient enrolment | 
| Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients | Determinants: Formulation of abatacept administered, country, age, gender, educational level, duration of arthritis, number of prescription medications, duration of therapy with abatacept, HCP guided or self-administration | At patient enrolment | 
| Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients | Determinants: Formulation of abatacept administered, country, age, gender, educational level, duration of arthritis, number of prescription medications, duration of therapy with abatacept, HCP guided or self-administration | At patient enrolment | 
| Determinants of Health Care Professional (HCP) understanding, Implementation regarding key messages contained in the PAC based on data collected in the abatacept IV and SC formulation PACs among HCPs | Determinants: type of HCP, role of the HCP, country, age and sex of the HCP, years in the specialty, number of HCPs in the unit, annual number of patients managed by the unit, number of patients for whom abatacept was prescribed in the previous 12 months, type of practice, type of institution (academic or non-academic), size of town | Day 1 | 
| Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for Tuberculosis (TB) prior to administration of therapy of abatacept |  | Upto 8 years | 
| Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for viral hepatitis before administration of therapy with abatacept |  | Upto 8 years | 
| Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention |  | Upto 8 years |