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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.
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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 |
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Inclusion Criteria:
Patient survey (cohort 1):
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):
Exclusion Criteria:
Patient survey:
HCP survey:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Limoges - Hopital Dupuytren | Limoges | 87042 | France | |||
| APHM - Hopital Sainte-Marguerite, Marseille |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| 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 |
| 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 |
| Paris |
| 75571 |
| France |
| Acura Kliniken | Bad Kreuznach | 55543 | Germany |
| Local Institution | Bad Kreuznach | 55543 | Germany |
| Bad Nauheim | Bad Nauheim | 61231 | Germany |
| Local Institution | Bad Nauheim | 61231 | Germany |
| Local Institution | Frankenberg | 9669 | Germany |
| Local Institution | Heidelberg | 69120 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Heidelberg | Heidelberg | 69121 | Germany |
| Local Institution | Zwickau | 8056 | Germany |
| Zwickau | Zwickau | 8056 | Germany |
| Hospital Coruña | A Coruña | 15006 | Spain |
| Hospital Ccal. de Barbastro | Barbastro | 22300 | Spain |
| Hospital Elche | Elche | 3203 | Spain |
| Hospital Elda | Elda | 3600 | Spain |
| Local Institution | Elda | 3600 | Spain |
| Hospital Getafe | Getafe | 28905 | Spain |
| Hospital Gregorio Marañon | Madrid | 28007 | Spain |
| Local Institution | Madrid | 28007 | Spain |
| Hospital Merida | Mérida | 6800 | Spain |
| Hospital Virgen del Puerto | Plasencia | 10600 | Spain |
| Local Institution | Plasencia | 10600 | Spain |
| Hospital Virgen Macarena | Seville | 41009 | Spain |
| Hospital Mutua de Terrasa | Terrassa | 8221 | Spain |
| Local Institution | Malmö | 20502 | Sweden |
| Local Institution | Solna | 17176 | Sweden |
| Nevil Hall Hospital | Abergavenny | NP7 7EG | United Kingdom |
| Local Institution | Basingstoke | RG24 9NA | United Kingdom |
| Royal Derby Hospital | Derby | DE22 3NE | United Kingdom |
| Barnsley Hospital NHS Foundation Trust | Dewsbury | WF13 4HS | United Kingdom |
| Eastbourne District Gen. Hosp. | East Sussex | BN21 2UD | United Kingdom |
| Local Institution | Harlow | CM20 1QX | United Kingdom |
| Princess Alexandra Hospital | Harlow | CM20 1QX | United Kingdom |
| Arrow Park Hospital | Metropolitan Borough of Wirral | CH49 5PE | United Kingdom |
| St Helens Hospital | St Helens | WA9 3DA | United Kingdom |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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