Long-term Experience With Abatacept SC in Routine Clinical Practice

Rheumatoid Arthritis Clinical Trial

— ASCORE  

Official title:

Long-term Experience With Abatacept SC in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090556
• Other study ID #: IM101-348
• Status: Completed
• Start date: March 26, 2013
• Est. completion date: January 29, 2019

Study information

• Verified date: December 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2954
• Est. completion date: January 29, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Australia	Local Institution	Geelong	Victoria
Austria	Local Institution	Wien
France	Local Institution	Lille Cedex
Germany	Local Institution	Dresden
Greece	Local Institution	Crete
Italy	Local Institution	Pavia
Monaco	Local Institution	Monaco
Netherlands	Local Institution	Amsterdam
Spain	Local Institution	Barcelona
Switzerland	Local Institution	Diessenhofen
United Kingdom	Local Institution	Cambridgeshire
United Kingdom	Local Institution	Hull	Yorkshire

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	inVentiv Health Clinical, PharmaNet

Countries where clinical trial is conducted

Australia,  Austria,  France,  Germany,  Greece,  Italy,  Monaco,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment experience and outcomes after Abatacept discontinuation and switch to a biologic agent or conventional disease modifying anti-rheumatismal drug (DMARD)		Up to 24 months
Other	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)		Up to 24 months
Other	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)		Up to 24 months
Other	Patient-reported elements which are most likely to lead to change in therapy (in the UK)		Up to 24 months
Primary	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		Up to 24 Months
Primary	Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort	Description include concomitant treatments, dosage and adherence to treatment	Up to 24 Months
Primary	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	Up to 24 Months
Primary	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)	Up to 24 Months
Primary	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	Up to 24 Months
Secondary	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	Up to 24 months
Secondary	Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified		Up to 24 months
Secondary	Time to discontinuation of Abatacept (whatever the formulation, SC or IV)		Up to 24 months

External Links

•   BMS Clinical Trial Patient Recruiting