Long-term Experience With Abatacept SC in Routine Clinical Practice (ASCORE)

January 4, 2022 updated by: Bristol-Myers Squibb
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2954

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Local Institution
  • Austria
      • Wien, Austria, A-1130
        • Local Institution
  • France
      • Lille Cedex, France, 59037
        • Local Institution
  • Germany
      • Dresden, Germany, D-01067
        • Local Institution
  • Greece
      • Crete, Greece, 71110
        • Local Institution
  • Italy
      • Pavia, Italy, 27100
        • Local Institution
  • Monaco
      • Monaco, Monaco, 98012
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1056 AB
        • Local Institution
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution
  • Switzerland
      • Diessenhofen, Switzerland, 8253
        • Local Institution
  • United Kingdom
      • Cambridgeshire, United Kingdom, CB2 2QQ
        • Local Institution
    • Yorkshire
      • Hull, Yorkshire, United Kingdom, HU3 2JZ
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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

Exclusion Criteria:

- Patients who are currently included in any interventional clinical trial in RA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Up to 24 Months
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
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
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)
Up to 24 Months
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
Up to 24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major determinants of Abatacept SC retention rate
Time Frame: Up to 24 months
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
Up to 24 months
Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified
Time Frame: Up to 24 months
Up to 24 months
Time to discontinuation of Abatacept (whatever the formulation, SC or IV)
Time Frame: Up to 24 months
Up to 24 months

Other Outcome Measures

Outcome Measure
Time Frame
Treatment experience and outcomes after Abatacept discontinuation and switch to a biologic agent or conventional disease modifying anti-rheumatismal drug (DMARD)
Time Frame: Up to 24 months
Up to 24 months
Build and validate a multigenic predictive model of abatacept clinical response in two different populations of abatacept patients (MTX-IR and anti TNF-IR) (in Spain)
Time Frame: Up to 24 months
Up to 24 months
Examine how patients self-reporting related to main ASCORE study treatment decisions and explore patients'acceptability of self-monitoring using qualitative methods (ART substudy, in the UK)
Time Frame: Up to 24 months
Up to 24 months
Patient-reported elements which are most likely to lead to change in therapy (in the UK)
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

inVentiv Health Clinical
PharmaNet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2013

Primary Completion (Actual)

January 29, 2019

Study Completion (Actual)

January 29, 2019

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-348

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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