Long-term Experience With Abatacept SC in Routine Clinical Practice

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02090556
• Date of registration: 19/02/2014
• Prospective Registration: No
• Primary sponsor: Bristol-Myers Squibb
• Public title: Long-term Experience With Abatacept SC in Routine Clinical Practice ASCORE
• Scientific title: Long-term Experience With Abatacept SC in Routine Clinical Practice
• Date of first enrolment: January 31, 2012
• Target sample size: 2896
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02090556
• Study type: Observational

Countries of recruitment

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

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Abatacept

Primary Outcome(s)

Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort [Time Frame: Up to 24 Months]

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: Acceptability of the pre-filled pen device based on questionnaires [Time Frame: 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]

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]

Secondary Outcome(s)

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]

Secondary ID(s)

IM101-348

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PharmaNet

inVentiv Health Clinical