Clinical trial NCT02632890: Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC
timeFrame: At patient enrolment
measure: Patient survey: Proportion of patients treated with abatacept who have received the PAC
timeFrame: At patient enrolment
measure: Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use
timeFrame: At patient enrolment
measure: Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment
timeFrame: At patient enrolment
measure: Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment
timeFrame: At patient enrolment
measure: Patient survey: Mean scores for correct responses for questions grouped by objectives
timeFrame: At patient enrolment
measure: Patient survey: Mean total score for correct responses
timeFrame: At patient enrolment
measure: HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC
timeFrame: Day 1
measure: HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: HCP survey: Mean total score for correct responses
timeFrame: Day 1
measure: HCP survey: Mean scores for correct responses for questions grouped by objectives
timeFrame: Day 1
measure: Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization
timeFrame: Approximately 3 months
Secondary outcomes:
measure: Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients
timeFrame: At patient enrolment
measure: Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients
timeFrame: At patient enrolment
measure: Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients
timeFrame: At patient enrolment
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Upto 8 years
measure: 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
timeFrame: Upto 8 years
measure: Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention
timeFrame: Upto 8 years
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU Limoges - Hopital Dupuytren
city: Paris
country: France
facility: APHM - Hopital Sainte-Marguerite, Marseille
city: Bad Kreuznach
country: Germany
facility: Acura Kliniken
city: Bad Kreuznach
country: Germany
facility: Local Institution
city: Bad Nauheim
country: Germany
facility: Bad Nauheim
city: Bad Nauheim
country: Germany
facility: Local Institution
city: Frankenberg
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Heidelberg
country: Germany
facility: Heidelberg
city: Zwickau
country: Germany
facility: Local Institution
city: Zwickau
country: Germany
facility: Zwickau
city: A Coruña
country: Spain
facility: Hospital Coruña
city: Barbastro
country: Spain
facility: Hospital Ccal. de Barbastro
city: Elche
country: Spain
facility: Hospital Elche
city: Elda
country: Spain
facility: Hospital Elda
city: Elda
country: Spain
facility: Local Institution
city: Getafe
country: Spain
facility: Hospital Getafe
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Local Institution
city: Merida
country: Spain
facility: Hospital Merida
city: Plasencia
country: Spain
facility: Hospital Virgen del Puerto
city: Plasencia
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Terrasa
country: Spain
facility: Hospital Mutua de Terrasa
city: Malmö
country: Sweden
facility: Local Institution
city: Solna
country: Sweden
facility: Local Institution
city: Abergavenny
country: United Kingdom
facility: Nevil Hall Hospital
city: Basingstoke
country: United Kingdom
facility: Local Institution
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Dewsbury
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
city: East Sussex
country: United Kingdom
facility: Eastbourne District Gen. Hosp.
city: Harlow
country: United Kingdom
facility: Local Institution
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
city: St. Helens
country: United Kingdom
facility: St Helens Hospital
city: Wirral
country: United Kingdom
facility: Arrow Park Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: