Rheumatoid ArthritisNCT02632890
Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 36 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 203 participants
- Where
- 36 sitesin 5 countries
- Study dates
- 29 Nov 2016to 28 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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):
- 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
Who cannot join
- 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
Trial locations and contacts
36 sites in 5 countries.
36 sites in 5 countries
Spain13 sites
Hospital Coruña
A Coruña, 15006
Hospital Ccal. de Barbastro
Barbastro, 22300
Hospital Elche
Elche, 3203
Hospital Elda
Elda, 3600
Local Institution
Elda, 3600
Hospital Getafe
Getafe, 28905
Hospital Gregorio Marañon
Madrid, 28007
Local Institution
Madrid, 28007
Hospital Merida
Mérida, 6800
Hospital Virgen del Puerto
Plasencia, 10600
Local Institution
Plasencia, 10600
Hospital Virgen Macarena
Seville, 41009
Hospital Mutua de Terrasa
Terrassa, 8221
Germany10 sites
Acura Kliniken
Bad Kreuznach, 55543
Local Institution
Bad Kreuznach, 55543
Bad Nauheim
Bad Nauheim, 61231
Local Institution
Bad Nauheim, 61231
Local Institution
Frankenberg, 9669
Local Institution
Heidelberg, 69120
Universitätsklinikum Heidelberg
Heidelberg, 69120
Heidelberg
Heidelberg, 69121
Local Institution
Zwickau, 8056
Zwickau
Zwickau, 8056
United Kingdom9 sites
Nevil Hall Hospital
Abergavenny, NP7 7EG
Local Institution
Basingstoke, RG24 9NA
Royal Derby Hospital
Derby, DE22 3NE
Barnsley Hospital NHS Foundation Trust
Dewsbury, WF13 4HS
Eastbourne District Gen. Hosp.
East Sussex, BN21 2UD
Local Institution
Harlow, CM20 1QX
Princess Alexandra Hospital
Harlow, CM20 1QX
Arrow Park Hospital
Metropolitan Borough of Wirral, CH49 5PE
St Helens Hospital
St Helens, WA9 3DA
France2 sites
CHU Limoges - Hopital Dupuytren
Limoges, 87042
APHM - Hopital Sainte-Marguerite, Marseille
Paris, 75571
About this study
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
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.
Read the detailed description
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC
Measured: At patient enrolment
Patient survey: Proportion of patients treated with abatacept who have received the PAC
Measured: At patient enrolment
Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use
Measured: At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment
Measured: At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment
Measured: At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives
Objectives: distribution, awareness, utility, utilization and knowledge
Measured: At patient enrolment
Patient survey: Mean total score for correct responses
Measured: At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC
Measured: Day 1
HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use
Measured: 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
Measured: Day 1
HCP survey: Mean total score for correct responses
Measured: Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives
Objectives: distribution, awareness, utility, utilization and knowledge
Measured: Day 1
Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization
Measured: 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
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
Measured: At patient enrolment
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Upto 8 years
Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention
Measured: Upto 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start29 Nov 2016
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632890
- Sponsor's protocol ID
- IM101-537
- Status last verified
- Jun 2017
- First submitted
- 10 Dec 2015
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02632890
- Acronym / sponsor ID
- IM101-537
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Patient survey (cohort 1):
- HCP survey (cohort 2):
- Retrospective chart review study (cohort 3):
Key exclusion criteria (6 listed)
- Patient survey:
- HCP survey:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC
Time frame: At patient enrolment
Patient survey: Proportion of patients treated with abatacept who have received the PAC
Time frame: At patient enrolment
Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use
Time frame: At patient enrolment
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
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment
Time frame: At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives
Time frame: At patient enrolment
Objectives: distribution, awareness, utility, utilization and knowledge
Patient survey: Mean total score for correct responses
Time frame: At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC
Time frame: Day 1
HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use
Time frame: 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
Time frame: Day 1
HCP survey: Mean total score for correct responses
Time frame: Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives
Time frame: Day 1
Objectives: distribution, awareness, utility, utilization and knowledge
Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization
Time frame: Approximately 3 months
7 secondary outcomes
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
Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients
Time frame: At patient enrolment
Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Upto 8 years
Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention
Time frame: Upto 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
36 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 36 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Spain, Germany, United Kingdom, France, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC (time frame: At patient enrolment). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.