Clinical trial NCT02109666: Long Term Experience With Abatacept in Routine Clinical Practice
Official title: Long Term Experience With Abatacept in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 2364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Crohn's Disease

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

Eligibility 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

Primary outcomes:
measure: Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice
timeFrame: Up to 24 months
Secondary outcomes:
measure: Major determinants of treatment discontinuation of RA patients treated with Abatacept
timeFrame: Up to 24 months
measure: Distribution of time-to-discontinuation of Abatacept therapy for each major determinant of treatment discontinuation, overall and depending on the treatment line
timeFrame: Up to 24 months
measure: Association of prior RA treatment experience and clinical outcomes during the treatment course with patient reported outcomes (Patient satisfaction, Pain, Patient's Global Assessment)
timeFrame: Up to 24 months
measure: 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
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Local Institution
city: Gent
country: Belgium
facility: Local Institution
city: St. John's
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Prague 2
country: Czech Republic
facility: Local Institution
city: Holbaek
country: Denmark
facility: Local Institution
city: Montpellier
country: France
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Crete
country: Greece
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Basel
country: Switzerland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Alten 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.
citation: Alten 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.
citation: Alten 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.
citation: Alten 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.