Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
- Registration Number
- NCT02037737
- Lead Sponsor
- Bristol-Myers Squibb
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RA patients on Abatacept IV Abatacept Rheumatoid Arthritis (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
- Primary Outcome Measures
Name Time Method 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 Up to 2 years of followup
- Secondary Outcome Measures
Name Time Method Abatacept effectiveness in the treated population 3, 6, and 12 months and every 3 months up to 2 years of followup Based on simplified disease activity score - 28 joints (DAS28), clinical disease activity index (CDAI), health assessment questionnaire (HAQ), and occurrence of serious adverse events
Impact of patient and disease characteristics on treatment outcomes Every 3 months up to 2 years of followup 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) Every 3 months up to 2 years of followup Conditions of Abatacept IV utilization in first line of biologic agents (indication, dosage, administration schedule, treatment duration, concomitant treatments) Every 3 months up to 2 years of followup Therapeutic strategies over time including change in concomitants treatments Every 3 months up to 2 years of followup The healthcare resource use as assessed by number of visits to any rheumatologists, hospitalizations Every 3 months up to 2 years of followup 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) Every 3 months up to 2 years of followup