Long Term Experience With Abatacept in Routine Clinical Practice

Rheumatoid Arthritis Clinical Trial

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Official title:

Long Term Experience With Abatacept in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109666
• Other study ID #: IM101-151
• Status: Completed
• Phase: N/A
• First received: April 8, 2014
• Last updated: April 17, 2017
• Start date: March 2008
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2364
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept

Locations

Country	Name	City	State
Austria	Local Institution	Salzburg
Belgium	Local Institution	Gent
Canada	Local Institution	St. John's	Newfoundland and Labrador
Czech Republic	Local Institution	Prague 2
Denmark	Local Institution	Holbaek
France	Local Institution	Montpellier
Germany	Local Institution	Heidelberg
Greece	Local Institution	Crete
Ireland	Local Institution	Dublin
Italy	Local Institution	Siena
Netherlands	Local Institution	Amsterdam
Spain	Local Institution	Sevilla
Switzerland	Local Institution	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Ireland,  Italy,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice		Up to 24 months
Secondary	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	Up to 24 months
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form