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Completed

NCT Number: NCT02090556

Long-term Experience With Abatacept SC in Routine Clinical Practice

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Geelong, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • PharmaNet
  • inVentiv Health Clinical

Registry information

Acronym: ASCORE

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2014
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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