Rheumatoid ArthritisASCORENCT02090556
Long-term Experience With Abatacept SC in Routine Clinical Practice
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 12 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 2,954 participants
- Where
- 12 sitesin 11 countries
- Study dates
- 26 Mar 2013to 29 Jan 2019
- 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: Corhort 1: RA patients naive of Abatacept and any other biologic agents. Corhort 2: RA patients naïve of Abatacept and who previously failed one or more biologic agents. In Germany, the study will be proposed to patients using syringe or pre-filled pen devices
Who may be able to join
- 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
Who cannot join
- Patients who are currently included in any interventional clinical trial in RA
Trial locations and contacts
12 sites in 11 countries.
12 sites in 11 countries
United Kingdom2 sites
Local Institution
Cambridgeshire, CB2 2QQ
Local Institution
Hull, Yorkshire, HU3 2JZ
About this study
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.
- 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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 24 Months
Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort
Description include concomitant treatments, dosage and adherence to treatment
Measured: Up to 24 Months
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
Measured: Up to 24 Months
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)
Measured: Up to 24 Months
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
Measured: Up to 24 Months
Secondary outcomes (3)
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
Measured: Up to 24 months
Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified
Measured: Up to 24 months
Time to discontinuation of Abatacept (whatever the formulation, SC or IV)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study start26 Mar 2013
- Primary completion29 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,954 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical, PharmaNet
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090556
- Sponsor's protocol ID
- IM101-348
- Acronym
- ASCORE
- Status last verified
- Dec 2021
- First submitted
- 19 Feb 2014
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Alten R, Behar C, Merckaert P, Afari E, Vannier-Moreau V, Ohayon A, Connolly SE, Najm A, Juge PA, Liu G, Rai A, Elbez Y, Lozenski K. Predicting abatacept retention using machine learning. Arthritis Res Ther. 2025 Feb 1;27(1):20. doi: 10.1186/s13075-025-03484-0.
PubMed 39893489Alten R, Tony HP, Bannert B, Nusslein H, Rauch C, Connolly SE, Chartier M, Lozenski K, Hackl R, Forster A, Peichl P. Subcutaneous abatacept for the treatment of rheumatoid arthritis in routine clinical practice in Germany, Austria, and Switzerland: 2-year retention and efficacy by treatment line and serostatus. Clin Rheumatol. 2023 Sep;42(9):2321-2334. doi: 10.1007/s10067-023-06649-x. Epub 2023 Jun 14.
PubMed 37314665Alten R, Mariette X, Flipo RM, Caporali R, Buch MH, Patel Y, Marsal S, Sanmarti R, Nurmohamed MT, Griffiths H, Peichl P, Bannert B, Chartier M, Connolly SE, Lozenski K, Rauch C. Retention of subcutaneous abatacept for the treatment of rheumatoid arthritis: real-world results from the ASCORE study: an international 2-year observational study. Clin Rheumatol. 2022 Aug;41(8):2361-2373. doi: 10.1007/s10067-022-06176-1. Epub 2022 May 10.
PubMed 35536413
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Experience With Abatacept SC in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02090556
- Acronym / sponsor ID
- ASCORE / IM101-348
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,954 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- inVentiv Health Clinical, PharmaNet
- Study start
- 26 Mar 2013 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 18 Mar 2014 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Corhort 1: RA patients naive of Abatacept and any other biologic agents. Corhort 2: RA patients naïve of Abatacept and who previously failed one or more biologic agents. In Germany, the study will be proposed to patients using syringe or pre-filled pen devices
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who are currently included in any interventional clinical trial in RA
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
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
Time frame: Up to 24 Months
Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort
Time frame: Up to 24 Months
Description include concomitant treatments, dosage and adherence to treatment
Co-Primary: Description of the major characteristics of Abatacept SC treated patients (joint population) at treatment initiation
Time frame: Up to 24 Months
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
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
Time frame: Up to 24 Months
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)
Co-Primary: Acceptability of the pre-filled pen device based on questionnaires
Time frame: Up to 24 Months
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
3 secondary outcomes
Major determinants of Abatacept SC retention rate
Time frame: Up to 24 months
Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified
Time frame: Up to 24 months
Time to discontinuation of Abatacept (whatever the formulation, SC or IV)
Time frame: Up to 24 months
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 19 Jan 2022.
- Derived from this study: PubMed 39893489Alten R, Behar C, Merckaert P, Afari E, Vannier-Moreau V, Ohayon A, Connolly SE, Najm A, Juge PA, Liu G, Rai A, Elbez Y, Lozenski K. Predicting abatacept retention using machine learning. Arthritis Res Ther. 2025 Feb 1;27(1):20. doi: 10.1186/s13075-025-03484-0.
- Derived from this study: PubMed 37314665Alten R, Tony HP, Bannert B, Nusslein H, Rauch C, Connolly SE, Chartier M, Lozenski K, Hackl R, Forster A, Peichl P. Subcutaneous abatacept for the treatment of rheumatoid arthritis in routine clinical practice in Germany, Austria, and Switzerland: 2-year retention and efficacy by treatment line and serostatus. Clin Rheumatol. 2023 Sep;42(9):2321-2334. doi: 10.1007/s10067-023-06649-x. Epub 2023 Jun 14.
- Derived from this study: PubMed 35536413Alten R, Mariette X, Flipo RM, Caporali R, Buch MH, Patel Y, Marsal S, Sanmarti R, Nurmohamed MT, Griffiths H, Peichl P, Bannert B, Chartier M, Connolly SE, Lozenski K, Rauch C. Retention of subcutaneous abatacept for the treatment of rheumatoid arthritis: real-world results from the ASCORE study: an international 2-year observational study. Clin Rheumatol. 2022 Aug;41(8):2361-2373. doi: 10.1007/s10067-022-06176-1. Epub 2022 May 10.
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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
12 sites in 11 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 12 sites in 11 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 8 inclusion and 1 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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Australia, Austria, France, Germany and 6 more countries. 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?
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 (time frame: Up to 24 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02090556, which also lists 3 linked publications.
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 19 Jan 2022.