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

14 juni 2017 uppdaterad av: Bristol-Myers Squibb

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.

Studieöversikt

Status

Avslutad

Betingelser

Reumatoid artrit

Detaljerad beskrivning

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

Studietyp

Observationell

Inskrivning (Faktisk)

203

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC Tidsram: At patient enrolment		At patient enrolment
Patient survey: Proportion of patients treated with abatacept who have received the PAC Tidsram: At patient enrolment		At patient enrolment
Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use Tidsram: At patient enrolment		At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment Tidsram: At patient enrolment		At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment Tidsram: At patient enrolment		At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives Tidsram: At patient enrolment	Objectives: distribution, awareness, utility, utilization and knowledge	At patient enrolment
Patient survey: Mean total score for correct responses Tidsram: At patient enrolment		At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC Tidsram: Day 1		Day 1
HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use Tidsram: Day 1		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 Tidsram: Day 1		Day 1
HCP survey: Mean total score for correct responses Tidsram: Day 1		Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives Tidsram: Day 1	Objectives: distribution, awareness, utility, utilization and knowledge	Day 1
Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization Tidsram: Approximately 3 months		Approximately 3 months

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients Tidsram: 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	At patient enrolment
Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients Tidsram: 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	At patient enrolment
Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients Tidsram: 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	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 Tidsram: 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	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 Tidsram: Upto 8 years		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 Tidsram: Upto 8 years		Upto 8 years
Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention Tidsram: Upto 8 years		Upto 8 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bristol-Myers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

BMS Clinical Trial Patient Recruiting

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 november 2016

Primärt slutförande (Faktisk)

28 april 2017

Avslutad studie (Faktisk)

28 april 2017

Studieregistreringsdatum

Först inskickad

10 december 2015

Först inskickad som uppfyllde QC-kriterierna

14 december 2015

Första postat (Uppskatta)

17 december 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juni 2017

Senast verifierad

1 juni 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

IM101-537

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .