Long-term Experience With Abatacept SC in Routine Clinical Practice

NCT02090556 | Completed

• 1 other identifier: IM101-348
• Study Type: observational
• Target: 2,954
• Locations: 10 countries
• Sites: 11

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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 Outcomes (3)

• Major determinants of Abatacept SC retention rate

  Up to 24 months

• 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

Other Outcomes (4)

• 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

• 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

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• inVentiv Health Clinical: collaborator
• PharmaNet: collaborator

Study Sites (12)

Local Institution

Geelong, Victoria, 3220, Australia

Location

Local Institution

Vienna, A-1130, Austria

Location

Local Institution

Lille, 59037, France

Location

Local Institution

Dresden, D-01067, Germany

Location

Local Institution

Crete, 71110, Greece

Location

Local Institution

Pavia, 27100, Italy

Location

Local Institution

Monaco, 98012, Monaco

Location

Local Institution

Amsterdam, 1056 AB, Netherlands

Location

Local Institution

Barcelona, 08036, Spain

Location

Local Institution

Diessenhofen, 8253, Switzerland

Location

Local Institution

Hull, Yorkshire, HU3 2JZ, United Kingdom

Location

Local Institution

Cambridgeshire, CB2 2QQ, United Kingdom

Location

Related Publications (3)

• Alten R, Behar C, Merckaert P, Afari E, Vannier-Moreau V, Ohayon A, Connolly SE, Najm A, Juge PA, Liu G, Rai A, Elbez Y, Lozenski K. Predicting abatacept retention using machine learning. Arthritis Res Ther. 2025 Feb 1;27(1):20. doi: 10.1186/s13075-025-03484-0.

  PMID: 39893489 DERIVED

• Alten R, Tony HP, Bannert B, Nusslein H, Rauch C, Connolly SE, Chartier M, Lozenski K, Hackl R, Forster A, Peichl P. Subcutaneous abatacept for the treatment of rheumatoid arthritis in routine clinical practice in Germany, Austria, and Switzerland: 2-year retention and efficacy by treatment line and serostatus. Clin Rheumatol. 2023 Sep;42(9):2321-2334. doi: 10.1007/s10067-023-06649-x. Epub 2023 Jun 14.

  PMID: 37314665 DERIVED

• 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.

  PMID: 35536413 DERIVED

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry form

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: March 18, 2014
• Study Start: March 26, 2013
• Primary Completion: January 29, 2019
• Study Completion: January 29, 2019
• Last Updated: January 19, 2022

Record last verified: 2021-12

Locations

AU (1); GR (1); IT (1); MO (1); DE (1); GB (2); FR (1); NL (1); ES (1); CH (1)