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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02109666
Date of registration: 08/04/2014
Prospective Registration: No
Primary sponsor: Bristol-Myers Squibb
Public title: Long Term Experience With Abatacept in Routine Clinical Practice ACTION
Scientific title: Long Term Experience With Abatacept in Routine Clinical Practice
Date of first enrolment: March 2008
Target sample size: 2364
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02109666
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Austria Belgium Canada Czech Republic Denmark France Germany Greece
Ireland Italy Netherlands Spain Switzerland
Contacts
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice [Time Frame: Up to 24 months]
Secondary Outcome(s)
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]
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]
Major determinants of treatment discontinuation of RA patients treated with Abatacept [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]
Secondary ID(s)
IM101-151
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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