Long Term Experience With Abatacept in Routine Clinical Practice (ACTION)

April 17, 2017 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Local Institution
  • Belgium
      • Gent, Belgium, 9000
        • Local Institution
  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B3E1
        • Local Institution
  • Czech Republic
      • Prague 2, Czech Republic, 128 50
        • Local Institution
  • Denmark
      • Holbaek, Denmark, 4300
        • Local Institution
  • France
      • Montpellier, France, 34295
        • Local Institution
  • Germany
      • Heidelberg, Germany, 64120
        • Local Institution
  • Greece
      • Crete, Greece, 71 201
        • Local Institution
  • Ireland
      • Dublin, Ireland, 4
        • Local Institution
  • Italy
      • Siena, Italy, 53100
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1056 AB
        • Local Institution
  • Spain
      • Sevilla, Spain, 41071
        • Local Institution
  • Switzerland
      • Basel, Switzerland, 4055
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Crohn's Disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RA patients treated with Abatacept
RA patients are treated with Abatacept IV according Summary of Product Characteristics (SmPC) in Europe and Product Monograph in Canada
Drug: Abatacept
Other Names:
  • Orencia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice
Time Frame: Up to 24 months
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major determinants of treatment discontinuation of RA patients treated with Abatacept
Time Frame: 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
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
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
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
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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