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

NCT02632890 | Completed

• 1 other identifier: IM101-537
• Study Type: observational
• Target: 203
• Locations: 5 countries
• Sites: 36

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (13)

• 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

  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

Secondary Outcomes (7)

• Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients

  At patient enrolment

• Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients

  At patient enrolment

• Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients

  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

  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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (36)

CHU Limoges - Hopital Dupuytren

Limoges, 87042, France

Location

APHM - Hopital Sainte-Marguerite, Marseille

Paris, 75571, France

Location

Acura Kliniken

Bad Kreuznach, 55543, Germany

Location

Local Institution

Bad Kreuznach, 55543, Germany

Location

Bad Nauheim

Bad Nauheim, 61231, Germany

Location

Local Institution

Bad Nauheim, 61231, Germany

Location

Local Institution

Frankenberg, 9669, Germany

Location

Local Institution

Heidelberg, 69120, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Heidelberg

Heidelberg, 69121, Germany

Location

Local Institution

Zwickau, 8056, Germany

Location

Zwickau

Zwickau, 8056, Germany

Location

Hospital Coruña

A Coruña, 15006, Spain

Location

Hospital Ccal. de Barbastro

Barbastro, 22300, Spain

Location

Hospital Elche

Elche, 3203, Spain

Location

Hospital Elda

Elda, 3600, Spain

Location

Local Institution

Elda, 3600, Spain

Location

Hospital Getafe

Getafe, 28905, Spain

Location

Hospital Gregorio Marañon

Madrid, 28007, Spain

Location

Local Institution

Madrid, 28007, Spain

Location

Hospital Merida

Mérida, 6800, Spain

Location

Hospital Virgen del Puerto

Plasencia, 10600, Spain

Location

Local Institution

Plasencia, 10600, Spain

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

Hospital Mutua de Terrasa

Terrassa, 8221, Spain

Location

Local Institution

Malmo, 20502, Sweden

Location

Local Institution

Solna, 17176, Sweden

Location

Nevil Hall Hospital

Abergavenny, NP7 7EG, United Kingdom

Location

Local Institution

Basingstoke, RG24 9NA, United Kingdom

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

Barnsley Hospital NHS Foundation Trust

Dewsbury, WF13 4HS, United Kingdom

Location

Eastbourne District Gen. Hosp.

East Sussex, BN21 2UD, United Kingdom

Location

Local Institution

Harlow, CM20 1QX, United Kingdom

Location

Princess Alexandra Hospital

Harlow, CM20 1QX, United Kingdom

Location

Arrow Park Hospital

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Location

St Helens Hospital

St Helens, WA9 3DA, United Kingdom

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: November 29, 2016
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

GB (9); FR (2); ES (13); SE (2); DE (10)