Long Term Experience With Abatacept in Routine Clinical Practice

Bristol-Myers Squibb2,364 enrolled

Overview

The purpose of this study is to estimate the retention rate of Abatacept over 24 months in routine clinical practice in every participating country depending on the treatment line.

Time Perspective: Other: Collection of the baseline data collected at Abatacept IV initiation, prospectively or retrospectively within maximum 3 months following the first administration. Other assessments are collected during the follow up period (maximum of 2 years by patient) Biospecimen Retention: None Retained excepted for a local sub study (in Spain) where sample with DNA was retained

Study Type

OBSERVATIONAL

Enrollment

2,364

Conditions

Rheumatoid Arthritis

Interventions

AbataceptDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Male or Female subjects of more than 18 years old * Patients with a diagnosis of established moderate to severe active RA (as per the American College of Rheumatology revised criteria, 1987), who at their physician's discretion are treated with Abatacept according to the SmPC in Europe and the Product Monograph in Canada (initiating or already on treatment for maximum 3 months) and for whom baseline characteristics are available Exclusion Criteria: * Patients who are currently included in any interventional clinical trial in RA

Locations (13)

Local Institution

Salzburg, Austria

Local Institution

Ghent, Belgium

Local Institution

St. John's, Newfoundland and Labrador, Canada

Outcomes

Primary Outcomes

Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice

Time frame: Up to 24 months

Secondary Outcomes

Major determinants of treatment discontinuation of RA patients treated with Abatacept

Major determinants including prior RA treatment experience with biologics and clinical outcomes, such as Disease Activity Score 28 (DAS28), Health Assessment Questionnaire-Disability Index (HAQ-DI), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI) and their derived criteria

Time frame: Up to 24 months

Distribution of time-to-discontinuation of Abatacept therapy for each major determinant of treatment discontinuation, overall and depending on the treatment line

Time frame: Up to 24 months

Association of prior RA treatment experience and clinical outcomes during the treatment course with patient reported outcomes (Patient satisfaction, Pain, Patient's Global Assessment)

Time frame: Up to 24 months

Summary of treatment experience and outcomes after switching to a biologic or conventional Disease Modifying Anti-Rheumatic Drugs (DMARD) for patients who discontinue Abatacept therapy

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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