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Trial record 62 of 69 for:    response | "Connective Tissue Disease" | "Abatacept"

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

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ClinicalTrials.gov Identifier: NCT02632890
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Rheumatoid Arthritis

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

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Study Type : Observational
Actual Enrollment : 203 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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
Actual Study Start Date : November 29, 2016
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

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



Primary Outcome Measures :
  1. Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC [ Time Frame: At patient enrolment ]
  2. Patient survey: Proportion of patients treated with abatacept who have received the PAC [ Time Frame: At patient enrolment ]
  3. Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use [ Time Frame: At patient enrolment ]
  4. Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment [ Time Frame: At patient enrolment ]
  5. Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment [ Time Frame: At patient enrolment ]
  6. Patient survey: Mean scores for correct responses for questions grouped by objectives [ Time Frame: At patient enrolment ]
    Objectives: distribution, awareness, utility, utilization and knowledge

  7. Patient survey: Mean total score for correct responses [ Time Frame: At patient enrolment ]
  8. HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC [ Time Frame: Day 1 ]
  9. HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use [ Time Frame: Day 1 ]
  10. 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 [ Time Frame: Day 1 ]
  11. HCP survey: Mean total score for correct responses [ Time Frame: Day 1 ]
  12. HCP survey: Mean scores for correct responses for questions grouped by objectives [ Time Frame: Day 1 ]
    Objectives: distribution, awareness, utility, utilization and knowledge

  13. Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization [ Time Frame: Approximately 3 months ]

Secondary Outcome Measures :
  1. Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients [ Time Frame: 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


  2. Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients [ Time Frame: 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


  3. Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients [ Time Frame: 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


  4. 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 [ Time Frame: 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

  5. 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 [ Time Frame: Upto 8 years ]
  6. 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 [ Time Frame: Upto 8 years ]
  7. Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention [ Time Frame: Upto 8 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632890


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

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02632890     History of Changes
Other Study ID Numbers: IM101-537
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents