Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting

Rheumatoid Arthritis Clinical Trial

— ReACTION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037737
• Other study ID #: IM101-409
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: February 6, 2018
• Start date: September 30, 2016
• Est. completion date: January 31, 2018

Study information

• Verified date: February 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Abatacept effectiveness in the treated population	Based on simplified disease activity score - 28 joints (DAS28), clinical disease activity index (CDAI), health assessment questionnaire (HAQ), and occurrence of serious adverse events	3, 6, and 12 months and every 3 months up to 2 years of followup
Secondary	Impact of patient and disease characteristics on treatment outcomes		Every 3 months up to 2 years of followup
Secondary	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
Secondary	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
Secondary	Therapeutic strategies over time including change in concomitants treatments		Every 3 months up to 2 years of followup
Secondary	The healthcare resource use as assessed by number of visits to any rheumatologists, hospitalizations		Every 3 months up to 2 years of followup
Secondary	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