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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02109666
Other study ID # IM101-151
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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