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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02632890
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-17
• Study Start: 2016-11-29
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCP survey: Mean total score for correct responses	Day 1
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: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment	At patient enrolment
Patient survey: Mean total score for correct responses	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 associated with abatacept treatment	At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives	At patient enrolment	Objectives: distribution, awareness, utility, utilization and knowledge
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
Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization	Approximately 3 months
HCP survey: Mean scores for correct responses for questions grouped by objectives	Day 1	Objectives: distribution, awareness, utility, utilization and knowledge

Secondary Outcome Measures

Name	Time	Method
Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients	At patient enrolment	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
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	Day 1	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
Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients	At patient enrolment	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
Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients	At patient enrolment	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
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

Trial Locations

Locations (25)

Heidelberg; 🇩🇪 Heidelberg, Germany

Local Institution; 🇬🇧 Harlow, United Kingdom

Bad Nauheim; 🇩🇪 Bad Nauheim, Germany

Hospital Coruña; 🇪🇸 A Coruña, Spain

Zwickau; 🇩🇪 Zwickau, Germany

Hospital Elche; 🇪🇸 Elche, Spain

Hospital Ccal. de Barbastro; 🇪🇸 Barbastro, Spain

Hospital Elda; 🇪🇸 Elda, Spain

Hospital Merida; 🇪🇸 Merida, Spain

Hospital Getafe; 🇪🇸 Getafe, Spain

Hospital Virgen del Puerto; 🇪🇸 Plasencia, Spain

Hospital Gregorio Marañon; 🇪🇸 Madrid, Spain

Royal Derby Hospital; 🇬🇧 Derby, United Kingdom

Hospital Mutua de Terrasa; 🇪🇸 Terrasa, Spain

Hospital Virgen Macarena; 🇪🇸 Sevilla, Spain

Nevil Hall Hospital; 🇬🇧 Abergavenny, United Kingdom

Princess Alexandra Hospital; 🇬🇧 Harlow, United Kingdom

Eastbourne District Gen. Hosp.; 🇬🇧 East Sussex, United Kingdom

Arrow Park Hospital; 🇬🇧 Wirral, United Kingdom

St Helens Hospital; 🇬🇧 St. Helens, United Kingdom

Barnsley Hospital NHS Foundation Trust; 🇬🇧 Dewsbury, United Kingdom

APHM - Hopital Sainte-Marguerite, Marseille; 🇫🇷 Paris, France

CHU Limoges - Hopital Dupuytren; 🇫🇷 Limoges, France

Acura Kliniken; 🇩🇪 Bad Kreuznach, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany