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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02090556




Registration number
NCT02090556
Ethics application status
Date submitted
19/02/2014
Date registered
18/03/2014
Date last updated
14/11/2018

Titles & IDs
Public title
Long-term Experience With Abatacept SC in Routine Clinical Practice
Scientific title
Long-term Experience With Abatacept SC in Routine Clinical Practice
Secondary ID [1] 0 0
IM101-348
Universal Trial Number (UTN)
Trial acronym
ASCORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept

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


Treatment: Drugs: Abatacept


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 24 Months
Primary outcome [2] 0 0
Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort - Description include concomitant treatments, dosage and adherence to treatment
Timepoint [2] 0 0
Up to 24 Months
Primary outcome [3] 0 0
Co-Primary: Description of the major characteristics of Abatacept SC treated patients (joint population) at treatment initiation - 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
Timepoint [3] 0 0
Up to 24 Months
Primary outcome [4] 0 0
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 - 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)
Timepoint [4] 0 0
Up to 24 Months
Primary outcome [5] 0 0
Co-Primary: Acceptability of the pre-filled pen device based on questionnaires - 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
Timepoint [5] 0 0
Up to 24 Months
Secondary outcome [1] 0 0
Major determinants of Abatacept SC retention rate - 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
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Time to discontinuation of Abatacept (whatever the formulation, SC or IV)
Timepoint [3] 0 0
Up to 24 months

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who are currently included in any interventional clinical trial in RA

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Geelong
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
France
State/province [2] 0 0
Lille Cedex
Country [3] 0 0
Germany
State/province [3] 0 0
Dresden
Country [4] 0 0
Greece
State/province [4] 0 0
Crete
Country [5] 0 0
Italy
State/province [5] 0 0
Pavia
Country [6] 0 0
Monaco
State/province [6] 0 0
Monaco
Country [7] 0 0
Netherlands
State/province [7] 0 0
Amsterdam
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Switzerland
State/province [9] 0 0
Diessenhofen
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Yorkshire
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Cambridgeshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
inVentiv Health Clinical
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
PharmaNet
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02090556
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications