Long Term Experience With Abatacept in Routine Clinical Practice

Conditions

Rheumatoid Arthritis

Brief summary

The purpose of this study is to estimate the retention rate of Abatacept over 24 months in routine clinical practice in every participating country depending on the treatment line.

Detailed description

Time Perspective: Other: Collection of the baseline data collected at Abatacept IV initiation, prospectively or retrospectively within maximum 3 months following the first administration. Other assessments are collected during the follow up period (maximum of 2 years by patient) Biospecimen Retention: None Retained excepted for a local sub study (in Spain) where sample with DNA was retained

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.

2025-02-012 citations

10.1186/s13075-025-03484-0

Up to 5-year retention of abatacept in Belgian patients with moderate-to-severe rheumatoid arthritis: a sub-analysis of the international, observational ACTION study.

Westhovens R, Connolly SE, Margaux J, Vanden Berghe M, Maertens M, Van den Berghe M, Elbez Y, Chartier M, Baeke F, Robert S, Malaise M.

2020-06-174 citations

10.1007/s00296-020-04619-z

Abatacept retention and clinical outcomes in Austrian patients with rheumatoid arthritis: real-world data from the 2-year ACTION study.

Peichl P, Alten R, Galeazzi M, Lorenz HM, Nüßlein H, Navarro F, Elbez Y, Chartier M, Hackl R, Rauch C, Connolly SE.

2019-10-255 citations

10.1007/s10354-019-00710-8

Abatacept retention and clinical outcomes in rheumatoid arthritis: real-world data from the German cohort of the ACTION study and a comparison with other participating countries.

Alten R, Feist E, Lorenz HM, Nüßlein H, Voll RE, Chartier M, Elbez Y, Rauch C.

2019-07-125 citations

10.1007/s10067-019-04648-5

Comparative Effectiveness of Abatacept Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis Who Are Anti-CCP Positive in the United States Corrona Registry.

Harrold LR, Litman HJ, Connolly SE, Alemao E, Kelly S, Rebello S, Hua W, Kremer JM.

2019-03-1316 citations

10.1007/s40744-019-0149-3

Predictors of abatacept retention over 2 years in patients with rheumatoid arthritis: results from the real-world ACTION study

Rieke Alten, Xavier Mariette, Hanns‐Martin Lorenz, H. Nüßlein, Mauro Galeazzi et al. (11 authors)

Clinical Rheumatology2019-02-2134 citations

10.1007/s10067-019-04449-w

Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting

Rieke Alten, Harald Burkhardt, Eugen Feist, Klaus Krüger, Jürgen Rech et al. (9 authors)

Arthritis Research & Therapy2018-01-0128 citations

10.1186/s13075-017-1488-5

Real-world predictors of 12–month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study

Rieke Alten, Xavier Mariette, Hanns‐Martin Lorenz, Mauro Galeazzi, A. Cantagrel et al. (10 authors)

RMD Open2017-12-0129 citations

10.1136/rmdopen-2017-000538

Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naïve: 6-month results from a real-world, international, prospective study

Rieke Alten, H. Nüßlein, Xavier Mariette, Mauro Galeazzi, Hanns‐Martin Lorenz et al. (10 authors)

RMD Open2017-02-0143 citations

10.1136/rmdopen-2016-000345

Interventions

DRUGAbatacept

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Male or Female subjects of more than 18 years old * Patients with a diagnosis of established moderate to severe active RA (as per the American College of Rheumatology revised criteria, 1987), who at their physician's discretion are treated with Abatacept according to the SmPC in Europe and the Product Monograph in Canada (initiating or already on treatment for maximum 3 months) and for whom baseline characteristics are available

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice	Up to 24 months

Secondary

Measure	Time frame	Description
Major determinants of treatment discontinuation of RA patients treated with Abatacept	Up to 24 months	Major determinants including prior RA treatment experience with biologics and clinical outcomes, such as Disease Activity Score 28 (DAS28), Health Assessment Questionnaire-Disability Index (HAQ-DI), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI) and their derived criteria
Distribution of time-to-discontinuation of Abatacept therapy for each major determinant of treatment discontinuation, overall and depending on the treatment line	Up to 24 months	—
Association of prior RA treatment experience and clinical outcomes during the treatment course with patient reported outcomes (Patient satisfaction, Pain, Patient's Global Assessment)	Up to 24 months	—
Summary of treatment experience and outcomes after switching to a biologic or conventional Disease Modifying Anti-Rheumatic Drugs (DMARD) for patients who discontinue Abatacept therapy	Up to 24 months	—

Countries

Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Spain, Switzerland

Outcome results

None listed