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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632890
• Other study ID #: IM101-537
• Status: Completed
• Phase: N/A
• First received: December 10, 2015
• Last updated: June 14, 2017
• Start date: November 29, 2016
• Est. completion date: April 28, 2017

Study information

• Verified date: June 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
France	CHU Limoges - Hopital Dupuytren	Limoges
France	APHM - Hopital Sainte-Marguerite, Marseille	Paris
Germany	Acura Kliniken	Bad Kreuznach
Germany	Local Institution	Bad Kreuznach
Germany	Bad Nauheim	Bad Nauheim
Germany	Local Institution	Bad Nauheim
Germany	Local Institution	Frankenberg
Germany	Heidelberg	Heidelberg
Germany	Local Institution	Heidelberg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Local Institution	Zwickau
Germany	Zwickau	Zwickau
Spain	Hospital Coruña	A Coruña
Spain	Hospital Ccal. de Barbastro	Barbastro
Spain	Hospital Elche	Elche
Spain	Hospital Elda	Elda
Spain	Local Institution	Elda
Spain	Hospital Getafe	Getafe
Spain	Hospital Gregorio Marañon	Madrid
Spain	Local Institution	Madrid
Spain	Hospital Merida	Merida
Spain	Hospital Virgen del Puerto	Plasencia
Spain	Local Institution	Plasencia
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital Mutua de Terrasa	Terrasa
Sweden	Local Institution	Malmö
Sweden	Local Institution	Solna
United Kingdom	Nevil Hall Hospital	Abergavenny
United Kingdom	Local Institution	Basingstoke
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	Barnsley Hospital NHS Foundation Trust	Dewsbury
United Kingdom	Eastbourne District Gen. Hosp.	East Sussex
United Kingdom	Local Institution	Harlow
United Kingdom	Princess Alexandra Hospital	Harlow
United Kingdom	St Helens Hospital	St. Helens
United Kingdom	Arrow Park Hospital	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

France,  Germany,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC		At patient enrolment
Primary	Patient survey: Proportion of patients treated with abatacept who have received the PAC		At patient enrolment
Primary	Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use		At patient enrolment
Primary	Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment		At patient enrolment
Primary	Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment		At patient enrolment
Primary	Patient survey: Mean scores for correct responses for questions grouped by objectives	Objectives: distribution, awareness, utility, utilization and knowledge	At patient enrolment
Primary	Patient survey: Mean total score for correct responses		At patient enrolment
Primary	HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC		Day 1
Primary	HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use		Day 1
Primary	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
Primary	HCP survey: Mean total score for correct responses		Day 1
Primary	HCP survey: Mean scores for correct responses for questions grouped by objectives	Objectives: distribution, awareness, utility, utilization and knowledge	Day 1
Primary	Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization		Approximately 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention		Upto 8 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
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