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

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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Abatacept

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

• Study Type: Observational
• Enrollment (Actual): 153

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RA patients on Abatacept IV; 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	Drug: Abatacept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2016
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Abatacept
• Other Study ID Numbers: IM101-409