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Completed

NCT Number: 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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Limoges - Hopital Dupuytren, Limoges, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient survey (cohort 1):
  • Patients has taken abatacept within the previous 3 months for rheumatoid arthritis
  • 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):
  • Patient survey questionnaire completed , Informed Consent Form (ICF) signed

Exclusion criteria

  • Patient survey:
  • Patient has participated in a clinical trial for their arthritis in the previous 12 months
  • Currently an employee of BMS
  • HCP survey:
  • Physicians or nurse who have recruited patients for the Patient survey
  • Currently an employee of BMS

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 17, 2015
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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