Long Term Experience With Abatacept in Routine Clinical Practice

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Abatacept

• Registration Number: NCT02109666
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2364

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA patients treated with Abatacept	Abatacept	RA patients are treated with Abatacept IV according Summary of Product Characteristics (SmPC) in Europe and Product Monograph in Canada

Primary Outcome Measures

Name	Time	Method
Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice	Up to 24 months

Secondary Outcome Measures

Name	Time	Method
Distribution of time-to-discontinuation of Abatacept therapy for each major determinant of treatment discontinuation, overall and depending on the treatment line	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)	Up to 24 months
Major determinants of treatment discontinuation of RA patients treated with Abatacept	Up to 24 months	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
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	Up to 24 months

Trial Locations

Locations (1)

Local Institution; 🇨🇭 Basel, Switzerland