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Long-term Experience With Abatacept SC in Routine Clinical Practice (ASCORE)

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ClinicalTrials.gov Identifier: NCT02090556
Recruitment Status : Active, not recruiting
First Posted : March 18, 2014
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
inVentiv Health Clinical
PharmaNet
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Abatacept

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Study Type : Observational
Estimated Enrollment : 2896 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Experience With Abatacept SC in Routine Clinical Practice
Actual Study Start Date : January 31, 2012
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Cohort 1:
RA patients naive of Abatacept and any other biologic agents
Drug: Abatacept
Other Name: Orencia

Cohort 2:
RA patients naive of Abatacept and who previously failed one or more biologic agents
Drug: Abatacept
Other Name: Orencia




Primary Outcome Measures :
  1. Key Primary: Median time and estimation of treatment retention rate of Rheumatoid arthritis (RA) patients treated with Abatacept subcutaneous (SC) over 24 months in routine clinical practices [ Time Frame: Up to 24 Months ]
  2. Co-Primary: Description of how Abatacept SC is prescribed in participating countries for each cohort [ Time Frame: Up to 24 Months ]
    Description include concomitant treatments, dosage and adherence to treatment

  3. Co-Primary: Description of the major characteristics of Abatacept SC treated patients (joint population) at treatment initiation [ Time Frame: Up to 24 Months ]
    Major characteristics of population of patients (joint population depending on previous prescriptions) include socio-demographic data, medical history, disease history, co-morbidities and clinical measures

  4. Co-Primary: Impact of the Abatacept SC treatment on health status of each population of patients over time as assessed by morbi-mortality criteria and safety [ Time Frame: Up to 24 Months ]
    Morbi-mortality criteria include clinical measures, Patient Reported Outcomes (PRO) including self-completion quality of life (QoL) questionnaires and healthcare resource use, incidence of local site injection reaction, incidence of long-term adverse events (AE), withdrawal from study due to AE and Serious Adverse Events (SAE)

  5. Co-Primary: Acceptability of the pre-filled pen device based on questionnaires [ Time Frame: Up to 24 Months ]
    Patients using the pre-filled pen will complete questionnaires on overall acceptability of the pre-filled pen device, injection site pain assessment and experience with previous injections


Secondary Outcome Measures :
  1. Major determinants of Abatacept SC retention rate [ Time Frame: Up to 24 months ]
    Major determinants including socio-demographic characteristics at treatment initiation, previous biologic treatments, clinical measurements (i.e. Simplified Disease Activity Score based on 28 joints (DAS28), Clinical Disease Activity Index (CDAI), Simple Disease Activity Index (SDAI) and their derived criteria) and PROs such as Health Assessment Questionnaire Disability Index (HAQ-DI) and according to local clinical practices and/or according to local requirements Work Productivity and Activity Impairment Questionnaire:Rheumatoid Arthritis (WPAI:RA), Rheumatoid Arthritis Disease Activity Index (RADAI) or PRO-CLinical Arthritis Activity (PROCLARA) at treatment initiation and/or at studied drug discontinuation

  2. Distribution of time-to-discontinuation of Abatacept SC therapy for each major determinant identified [ Time Frame: Up to 24 months ]
  3. Time to discontinuation of Abatacept (whatever the formulation, SC or IV) [ Time Frame: Up to 24 months ]

Other Outcome Measures:
  1. Treatment experience and outcomes after Abatacept discontinuation and switch to a biologic agent or conventional disease modifying anti-rheumatismal drug (DMARD) [ Time Frame: Up to 24 months ]
  2. Build and validate a multigenic predictive model of abatacept clinical response in two different populations of abatacept patients (MTX-IR and anti TNF-IR) (in Spain) [ Time Frame: Up to 24 months ]
  3. Examine how patients self-reporting related to main ASCORE study treatment decisions and explore patients'acceptability of self-monitoring using qualitative methods (ART substudy, in the UK) [ Time Frame: Up to 24 months ]
  4. Patient-reported elements which are most likely to lead to change in therapy (in the UK) [ Time Frame: Up to 24 months ]

Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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

Corhort 1: RA patients naive of Abatacept and any other biologic agents.

Corhort 2: RA patients naïve of Abatacept and who previously failed one or more biologic agents.

In Germany, the study will be proposed to patients using syringe or pre-filled pen devices

Criteria

Inclusion Criteria:

  • Patients ≥18 years old at treatment initiation
  • Patients diagnosed with established moderate to severe active RA as per the 1987 ACR criteria/2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Rheumatoid Arthritis Classification Criteria
  • Patients naïve of Abatacept IV and who at their physician's discretion are initiated with Abatacept SC. In countries where required (e.g. Germany and Spain), patients naïve of Abatacept IV and who at their physician's discretion have been initiated with Abatacept SC at least 1 month prior to enrollment visit up to 6 months if baseline and disease characteristics data are available
  • For Spanish pharmacogenomic sub-study:
  • Caucasian patient and from European ancestry
  • Patient for whom a collection of blood sample before the initiation of abatacept is possible or available (blood sample was taken in routine practice before the study enrolment)
  • Patient who agreed to participate in this substudy and provide a specific signed Pharmacogenomic Blood RNA informed consent
  • In the UK, the ART substudy will be proposed to all patients enrolled in ASCORE from amendment approval and application date

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): NCT02090556


Locations
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Australia, Victoria
Local Institution
Geelong, Victoria, Australia, 3220
Austria
Local Institution
Wien, Austria, A-1130
France
Local Institution
Lille Cedex, France, 59037
Germany
Local Institution
Dresden, Germany, D-01067
Greece
Local Institution
Crete, Greece, 71110
Italy
Local Institution
Pavia, Italy, 27100
Monaco
Local Institution
Monaco, Monaco, 98012
Netherlands
Local Institution
Amsterdam, Netherlands, 1056 AB
Spain
Local Institution
Barcelona, Spain, 08036
Switzerland
Local Institution
Diessenhofen, Switzerland, 8253
United Kingdom
Local Institution
Hull, Yorkshire, United Kingdom, HU3 2JZ
Local Institution
Cambridgeshire, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Bristol-Myers Squibb
inVentiv Health Clinical
PharmaNet
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02090556     History of Changes
Other Study ID Numbers: IM101-348
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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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