Clinical trial NCT02090556: Long-term Experience With Abatacept SC in Routine Clinical Practice
Official title: Long-term Experience With Abatacept SC in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: inVentiv Health Clinical
name: PharmaNet
First posted: 2014-03-18
Enrollment: 2954
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Up to 24 Months
measure: Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort
timeFrame: Up to 24 Months
measure: Co-Primary: Description of the major characteristics of Abatacept SC treated patients (joint population) at treatment initiation
timeFrame: Up to 24 Months
measure: 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
timeFrame: Up to 24 Months
measure: Co-Primary: Acceptability of the pre-filled pen device based on questionnaires
timeFrame: Up to 24 Months
Secondary outcomes:
measure: Major determinants of Abatacept SC retention rate
timeFrame: Up to 24 months
measure: Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified
timeFrame: Up to 24 months
measure: Time to discontinuation of Abatacept (whatever the formulation, SC or IV)
timeFrame: Up to 24 months
Other outcomes:
measure: Treatment experience and outcomes after Abatacept discontinuation and switch to a biologic agent or conventional disease modifying anti-rheumatismal drug (DMARD)
timeFrame: Up to 24 months
measure: 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)
timeFrame: Up to 24 months
measure: 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)
timeFrame: Up to 24 months
measure: Patient-reported elements which are most likely to lead to change in therapy (in the UK)
timeFrame: Up to 24 months
Locations:
city: Geelong
country: Australia
facility: Local Institution
state: Victoria
city: Wien
country: Austria
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Crete
country: Greece
facility: Local Institution
city: Pavia
country: Italy
facility: Local Institution
city: Monaco
country: Monaco
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Diessenhofen
country: Switzerland
facility: Local Institution
city: Hull
country: United Kingdom
facility: Local Institution
state: Yorkshire
city: Cambridgeshire
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Alten 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.