Long-term Experience With Abatacept SC in Routine Clinical Practice

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02090556
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-26
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Primary Completion: 2019-01-29
• Study Completion: 2019-01-29
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2954

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort	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	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	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	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Cambridgeshire, United Kingdom