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

Bristol-Myers Squibb203 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

203

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient survey (cohort 1): 1. Patients has taken abatacept within the previous 3 months for rheumatoid arthritis 2. 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): 1. Patient survey questionnaire completed , Informed Consent Form (ICF) signed Exclusion Criteria: * Patient survey: 1. Patient has participated in a clinical trial for their arthritis in the previous 12 months 2. Currently an employee of BMS * HCP survey: 1. Physicians or nurse who have recruited patients for the Patient survey 2. Currently an employee of BMS

Locations (36)

Outcomes

Primary Outcomes

Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC

Time frame: At patient enrolment

Patient survey: Proportion of patients treated with abatacept who have received the PAC

Time frame: At patient enrolment

Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use

Time frame: At patient enrolment

Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment

Time frame: At patient enrolment

Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment

Time frame: At patient enrolment

Patient survey: Mean scores for correct responses for questions grouped by objectives

Objectives: distribution, awareness, utility, utilization and knowledge

Time frame: At patient enrolment

Patient survey: Mean total score for correct responses

Time frame: At patient enrolment

HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC

Time frame: Day 1

HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use

Time frame: 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

Data from ClinicalTrials.gov

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CHU Limoges - Hopital Dupuytren

Limoges, France

APHM - Hopital Sainte-Marguerite, Marseille

Paris, France

Acura Kliniken

Bad Kreuznach, Germany

Local Institution

Bad Kreuznach, Germany

Bad Nauheim

Bad Nauheim, Germany

Local Institution

Bad Nauheim, Germany

Local Institution

Frankenberg, Germany

Local Institution

Heidelberg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Heidelberg

Heidelberg, Germany

...and 26 more locations

Secondary Outcomes

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

Time frame: At patient enrolment

Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients

Time frame: At patient enrolment

Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Upto 8 years

Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention

Time frame: Upto 8 years