Long Term Experience With Abatacept in Routine Clinical Practice
ACTION
1 other identifier
observational
2,364
13 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 8, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 19, 2017
February 1, 2016
7.9 years
April 8, 2014
April 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice
Up to 24 months
Secondary Outcomes (4)
Major determinants of treatment discontinuation of RA patients treated with Abatacept
Up to 24 months
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
Study Arms (1)
RA patients treated with Abatacept
RA patients are treated with Abatacept IV according Summary of Product Characteristics (SmPC) in Europe and Product Monograph in Canada
Interventions
Eligibility Criteria
Crohn's Disease
You may qualify if:
- 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
You may not qualify if:
- Patients who are currently included in any interventional clinical trial in RA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Local Institution
Salzburg, 5020, Austria
Local Institution
Ghent, 9000, Belgium
Local Institution
St. John's, Newfoundland and Labrador, A1B3E1, Canada
Local Institution
Prague, 128 50, Czechia
Local Institution
Holbæk, 4300, Denmark
Local Institution
Montpellier, 34295, France
Local Institution
Heidelberg, 64120, Germany
Local Institution
Crete, 71 201, Greece
Local Institution
Dublin, Dublin, 4, Ireland
Local Institution
Siena, 53100, Italy
Local Institution
Amsterdam, 1056 AB, Netherlands
Local Institution
Seville, 41071, Spain
Local Institution
Basel, 4055, Switzerland
Related Publications (5)
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: 39893489DERIVEDAlten R, Mariette X, Lorenz HM, Nusslein H, Galeazzi M, Navarro F, Chartier M, Heitzmann J, Poncet C, Rauch C, Le Bars M. Predictors of abatacept retention over 2 years in patients with rheumatoid arthritis: results from the real-world ACTION study. Clin Rheumatol. 2019 May;38(5):1413-1424. doi: 10.1007/s10067-019-04449-w. Epub 2019 Feb 21.
PMID: 30790095DERIVEDAlten R, Mariette X, Lorenz HM, Galeazzi M, Cantagrel A, Nusslein HG, Chartier M, Elbez Y, Rauch C, Le Bars M. Real-world predictors of 12-month intravenous abatacept retention in patients with rheumatoid arthritis in the ACTION observational study. RMD Open. 2017 Dec 29;3(2):e000538. doi: 10.1136/rmdopen-2017-000538. eCollection 2017.
PMID: 29435360DERIVEDAlten R, Burkhardt H, Feist E, Kruger K, Rech J, Rubbert-Roth A, Voll RE, Elbez Y, Rauch C. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res Ther. 2018 Jan 2;20(1):1. doi: 10.1186/s13075-017-1488-5.
PMID: 29329602DERIVEDAlten R, Nusslein HG, Mariette X, Galeazzi M, Lorenz HM, Cantagrel A, Chartier M, Poncet C, Rauch C, Le Bars M. Baseline autoantibodies preferentially impact abatacept efficacy in patients with rheumatoid arthritis who are biologic naive: 6-month results from a real-world, international, prospective study. RMD Open. 2017 Feb 13;3(1):e000345. doi: 10.1136/rmdopen-2016-000345. eCollection 2017.
PMID: 28243468DERIVED
Related Links
Biospecimen
Whole blood (Spanish sub study only)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2014
First Posted
April 10, 2014
Study Start
March 1, 2008
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 19, 2017
Record last verified: 2016-02