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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • CHU Limoges - Hopital Dupuytren
  • Paris, France, 75571
    • APHM - Hopital Sainte-Marguerite, Marseille
• Germany
  • Bad Kreuznach, Germany, 55543
    • Acura Kliniken
  • Bad Kreuznach, Germany, 55543
    • Local Institution
  • Bad Nauheim, Germany, 61231
    • Local Institution
  • Bad Nauheim, Germany, 61231
    • Bad Nauheim
  • Frankenberg, Germany, 9669
    • Local Institution
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Heidelberg, Germany, 69120
    • Local Institution
  • Heidelberg, Germany, 69121
    • Heidelberg
  • Zwickau, Germany, 8056
    • Local Institution
  • Zwickau, Germany, 8056
    • Zwickau
• Spain
  • A Coruña, Spain, 15006
    • Hospital Coruña
  • Barbastro, Spain, 22300
    • Hospital Ccal. de Barbastro
  • Elche, Spain, 3203
    • Hospital Elche
  • Elda, Spain, 3600
    • Hospital Elda
  • Elda, Spain, 3600
    • Local Institution
  • Getafe, Spain, 28905
    • Hospital Getafe
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañón
  • Madrid, Spain, 28007
    • Local Institution
  • Merida, Spain, 6800
    • Hospital Merida
  • Plasencia, Spain, 10600
    • Hospital Virgen del Puerto
  • Plasencia, Spain, 10600
    • Local Institution
  • Sevilla, Spain, 41009
    • Hospital Virgen Macarena
  • Terrasa, Spain, 8221
    • Hospital Mutua de Terrasa
• Sweden
  • Malmö, Sweden, 20502
    • Local Institution
  • Solna, Sweden, 17176
    • Local Institution
• United Kingdom
  • Abergavenny, United Kingdom, NP7 7EG
    • Nevil Hall Hospital
  • Basingstoke, United Kingdom, RG24 9NA
    • Local Institution
  • Derby, United Kingdom, DE22 3NE
    • Royal Derby Hospital
  • Dewsbury, United Kingdom, WF13 4HS
    • Barnsley Hospital NHS Foundation Trust
  • East Sussex, United Kingdom, BN21 2UD
    • Eastbourne District Gen. Hosp.
  • Harlow, United Kingdom, CM20 1QX
    • Princess Alexandra Hospital
  • Harlow, United Kingdom, CM20 1QX
    • Local Institution
  • St. Helens, United Kingdom, WA9 3DA
    • St Helens Hospital
  • Wirral, United Kingdom, CH49 5PE
    • Arrow Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cohort 1: Patients enrolled by physician or nurse based in hospital rheumatology departments and physician clinics and offices

Cohort 2: Physician or nurse based in hospital RA department and physician clinics and offices

Cohort 3: Patients enrolled by physician or nurse based in hospital rheumatology departments and physician clinics and offices

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients survey; Adult patients treated with abatacept for rheumatoid arthritis
HCP survey; HCP with at least 1 patient taking abatacept
Retrospective chart review study; 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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: IM101-537