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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02109666
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Abatacept

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
Actual Enrollment : 2364 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Experience With Abatacept in Routine Clinical Practice
Study Start Date : March 2008
Primary Completion Date : February 2016
Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept
U.S. FDA Resources

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 Name: Orencia



Primary Outcome Measures :
  1. Retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept in routine clinical practice [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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 ]
  4. 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 ]

Biospecimen Retention:   None Retained
Whole blood (Spanish sub study only)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Crohn's Disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109666


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02109666     History of Changes
Other Study ID Numbers: IM101-151
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: February 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents