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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02090556
Registration number
NCT02090556
Ethics application status
Date submitted
19/02/2014
Date registered
18/03/2014
Date last updated
19/01/2022
Titles & IDs
Public title
Long-term Experience With Abatacept SC in Routine Clinical Practice
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Scientific title
Long-term Experience With Abatacept SC in Routine Clinical Practice
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Secondary ID [1]
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IM101-348
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Universal Trial Number (UTN)
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Trial acronym
ASCORE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Cohort 1: - RA patients naive of Abatacept and any other biologic agents
Cohort 2: - RA patients naive of Abatacept and who previously failed one or more biologic agents
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Key Primary: Median time and estimation of treatment retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept subcutaneous (SC) over 24 months in routine clinical practices
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Assessment method [1]
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Timepoint [1]
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Up to 24 Months
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Primary outcome [2]
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Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort
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Assessment method [2]
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Description include concomitant treatments, dosage and adherence to treatment
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Timepoint [2]
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Up to 24 Months
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Primary outcome [3]
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Co-Primary: Description of the major characteristics of Abatacept SC treated patients (joint population) at treatment initiation
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Assessment method [3]
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Major characteristics of population of patients (joint population depending on previous prescriptions) include socio-demographic data, medical history, disease history, co-morbidities and clinical measures
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Timepoint [3]
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Up to 24 Months
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Primary outcome [4]
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Co-Primary: Impact of the Abatacept SC treatment on health status of each population of patients over time as assessed by morbi-mortality criteria and safety
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Assessment method [4]
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Morbi-mortality criteria include clinical measures, Patient Reported Outcomes (PRO) including self-completion quality of life (QoL) questionnaires and healthcare resource use, incidence of local site injection reaction, incidence of long-term adverse events (AE), withdrawal from study due to AE and Serious Adverse Events (SAE)
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Timepoint [4]
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Up to 24 Months
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Primary outcome [5]
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Co-Primary: Acceptability of the pre-filled pen device based on questionnaires
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Assessment method [5]
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Patients using the pre-filled pen will complete questionnaires on overall acceptability of the pre-filled pen device, injection site pain assessment and experience with previous injections
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Timepoint [5]
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Up to 24 Months
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Secondary outcome [1]
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Major determinants of Abatacept SC retention rate
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Assessment method [1]
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Major determinants including socio-demographic characteristics at treatment initiation, previous biologic treatments, clinical measurements (i.e. Simplified Disease Activity Score based on 28 joints (DAS28), Clinical Disease Activity Index (CDAI), Simple Disease Activity Index (SDAI) and their derived criteria) and PROs such as Health Assessment Questionnaire Disability Index (HAQ-DI) and according to local clinical practices and/or according to local requirements Work Productivity and Activity Impairment Questionnaire:Rheumatoid Arthritis (WPAI:RA), Rheumatoid Arthritis Disease Activity Index (RADAI) or PRO-CLinical Arthritis Activity (PROCLARA) at treatment initiation and/or at studied drug discontinuation
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Timepoint [1]
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Up to 24 months
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Secondary outcome [2]
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Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified
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Assessment method [2]
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Timepoint [2]
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Up to 24 months
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Secondary outcome [3]
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Time to discontinuation of Abatacept (whatever the formulation, SC or IV)
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Assessment method [3]
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Timepoint [3]
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Up to 24 months
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Eligibility
Key inclusion criteria
- Patients =18 years old at treatment initiation
- Patients diagnosed with established moderate to severe active RA as per the 1987 ACR
criteria/2010 American College of Rheumatology (ACR)/European League Against
Rheumatism (EULAR) Rheumatoid Arthritis Classification Criteria
- Patients naïve of Abatacept IV and who at their physician's discretion are initiated
with Abatacept SC. In countries where required (e.g. Germany and Spain), patients
naïve of Abatacept IV and who at their physician's discretion have been initiated with
Abatacept SC at least 1 month prior to enrollment visit up to 6 months if baseline and
disease characteristics data are available
- For Spanish pharmacogenomic sub-study:
- Caucasian patient and from European ancestry
- Patient for whom a collection of blood sample before the initiation of abatacept is
possible or available (blood sample was taken in routine practice before the study
enrolment)
- Patient who agreed to participate in this substudy and provide a specific signed
Pharmacogenomic Blood RNA informed consent
- In the UK, the ART substudy will be proposed to all patients enrolled in ASCORE from
amendment approval and application date
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who are currently included in any interventional clinical trial in RA
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/03/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/01/2019
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Sample size
Target
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Accrual to date
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Final
2954
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Local Institution - Geelong
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Recruitment postcode(s) [1]
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3220 - Geelong
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Wien
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Country [2]
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France
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State/province [2]
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Lille Cedex
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Country [3]
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Germany
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State/province [3]
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Dresden
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Country [4]
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Greece
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State/province [4]
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Crete
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Country [5]
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Italy
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State/province [5]
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Pavia
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Country [6]
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Monaco
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State/province [6]
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Monaco
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Country [7]
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Netherlands
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State/province [7]
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Amsterdam
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Country [8]
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Spain
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State/province [8]
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Barcelona
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Country [9]
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Switzerland
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State/province [9]
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Diessenhofen
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Country [10]
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United Kingdom
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State/province [10]
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Yorkshire
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Country [11]
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United Kingdom
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State/province [11]
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Cambridgeshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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inVentiv Health Clinical
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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PharmaNet
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in
routine clinical practice, in rheumatoid arthritis patients, in each country involved in the
study. The purpose of the UK substudy is to explore whether integrating self-assessment into
routine care could maintain tight control (of inflammation/disease activity) and at
potentially lower cost resulting in improved health outcomes and cost-effectiveness.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02090556
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02090556
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