Clinical trial NCT02037737: Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
Official title: Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-01-16
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RA patients with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV according to routine clinical practice in France

Brief summary: The purpose of this study is to assess Abatacept Intravenous (IV) effectiveness in patients with inadequate response to one or more conventional Disease Modifying Against Rheumatism (DMARDs) including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation

Detailed description: Observational Model:

Other: ReACTION is a study using secondary data originally collected in ACTION study. In ACTION, data were collected prospectively from October 2010 up to 2015 at each clinical visit. In France, data collection started in June 2011

Eligibility criteria: Inclusion Criteria:

- All patients enrolled in ACTION with inadequate response to one or more conventional DMARDs including Methotrexate and treated with Abatacept IV will be included in ReACTION

ACTION inclusion criteria for France were:

* Male or female subjects of more than 18 years old
* Patients with a diagnosis of established moderate to severe active RA
* Patients who at their physician's discretion are treated with Abatacept (initiated or already on treatment within 3 months) according to routine clinical practice
* Patients for whom baseline characteristics are available
* Patients consent for usage of their data in ACTION study
* Patients who were not included in any interventional clinical trial in RA

Primary outcomes:
measure: Abatacept IV effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate in France, through the estimation of Abatacept retention rate over 2 years and reasons of discontinuation
timeFrame: Up to 2 years of followup
Secondary outcomes:
measure: Abatacept effectiveness in the treated population
timeFrame: 3, 6, and 12 months and every 3 months up to 2 years of followup
measure: Impact of patient and disease characteristics on treatment outcomes
timeFrame: Every 3 months up to 2 years of followup
measure: Joint population of French patients with inadequate response to one or more conventional DMARDs including Methotrexate treated with Abatacept IV (demographics, medical history, disease characteristics, previous treatments)
timeFrame: Every 3 months up to 2 years of followup
measure: Conditions of Abatacept IV utilization in first line of biologic agents (indication, dosage, administration schedule, treatment duration, concomitant treatments)
timeFrame: Every 3 months up to 2 years of followup
measure: Therapeutic strategies over time including change in concomitants treatments
timeFrame: Every 3 months up to 2 years of followup
measure: The healthcare resource use as assessed by number of visits to any rheumatologists, hospitalizations
timeFrame: Every 3 months up to 2 years of followup
measure: Abatacept effectiveness in patients with inadequate response to one or more conventional DMARDs including Methotrexate of the patients treated with Abatacept IV according to Summary Product Characteristics (SmPC)
timeFrame: Every 3 months up to 2 years of followup
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: