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

N/ACompletedNCT02037737

Bristol-Myers Squibb153 enrolled

Overview

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

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

153

Conditions

Rheumatoid Arthritis

Interventions

AbataceptDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Up to 2 years of followup

Secondary Outcomes

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

Time frame: 3, 6, and 12 months and every 3 months up to 2 years of followup

Impact of patient and disease characteristics on treatment outcomes