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Completed

NCT Number: NCT03188081

A Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous (SC) Abatacept

The primary objective of this study is to investigate whether an Educational Supported Program (ESP), including tight control procedures implemented through patient home care, has positive impact in terms of better adherence to the therapy with abatacept SC at 12 months after treatment start (1st injection). In the scope of this objective the adherence is measured by the Medication Adherence Questionnaire (MAQ).

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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

Brescia, 25123, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent to participate in the study signed by the patient
  • Age ≥ 18 years at the date of consent subscription
  • Diagnosis of active Rheumatoid Arthritis moderate to severe as per the 1987 American College of Rheumatology (ACR) criteria/2010 ACR/ European League Against Rheumatism (EULAR) RA Classification Criteria
  • Naïve of abatacept
  • Initiated with abatacept SC either as 1st or 2nd line biologic treatment after inadequate response to previous therapy with one or more DMARDs according to Summary of Product Characteristics (SmPC) locally approved

Exclusion criteria

  • Participating in clinical trial or other non-interventional studies, excluding registries
  • Inability to read and write
  • Any condition that in the investigator's opinion might jeopardize the follow-up and the data collection for the entire study observation period (24 months)

Treatment and study plan

Primary outcomes

  1. Change in Medication Adherence Questionnaire (MAQ)

    Time frame: 12 months and 24 months

    To investigate whether an Educational Support Program (ESP), including tight control procedures implemented through patient home care, has positive impact in terms of better adherence to the therapy with abatacept SC at 12 months and 24 months after treatment start (1st injection)

  2. Adherence ratio

    Time frame: 24 months

    Percentage ratio between the total number of injections taken in a treatment period and the total number of injections expected to be taken in the same treatment period according to rheumatologist prescription

Secondary outcomes

  1. Distribution of socio-demographic data

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation

  2. Patient Rheumatoid Arthritis History

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation

  3. Co-morbidities

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation

  4. Clinical measurements (disease indices and relevant subcomponents)

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation

  5. Erythrocyte Sedimentation Rate

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation

  6. Rheumatoid Factor

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation

  7. Anti Citrullinated Peptide Antibody

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation

  8. Prior RA treatments

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation

  9. Patient's reported assessment of health measured by HAQ-DI

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation and to investigate whether a better adherence to the abatacept SC therapy is associated to a better health status of the patient population

  10. Health related quality of life measured by EQ-5D

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation and to investigate whether a better adherence to the abatacept SC therapy is associated to a better health status of the patient population

  11. Remission rate measured by MAQ

    Time frame: 24 months

    To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population

  12. Low disease activity rate measured by MAQ

    Time frame: 24 months

    To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population

  13. DAS28 score measured by MAQ

    Time frame: 24 months

    To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population

  14. Concomitant medication for RA (Synthetic DMARDs and corticosteroids)

    Time frame: 24 months

    To describe the use of concomitant medication for RA (Synthetic DMARDs and corticosteroids) over the study observation period

  15. Adverse Events

    Time frame: 24 months

    To describe the incidence of Adverse Events, by seriousness and relationship with abatacept SC

  16. Reason for Withdrawal, where applicable

    Time frame: 24 months

    To describe the incidence of the reasons for withdrawal from the treatment and the study

  17. Retention rate

    Time frame: 24 months

    To evaluate the retention rate calculated as the time-to-discontinuation of abatacept SC treatment over the study observation period

  18. Cost-utility analysis (CUA)

    Time frame: 24 months

    To perform a cost-utility analysis (CUA) from the National Health System

  19. Societal perspective comparing health consequences

    Time frame: 24 months

    Societal perspective comparing health consequences Quality Adjusted Life Years (QALYs)

  20. Cost of alternative follow-up strategies

    Time frame: 24 months

    Two alternative follow-up strategies: ESP versus standard control

  21. Patient's reported assessment of health measured by Pain VAS

    Time frame: 24 months

    To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation and to investigate whether a better adherence to the abatacept SC therapy is associated to a better health status of the patient population

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Prospective, Multicentric, Observational Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life RA Patients Treated With Abatacept SC

Acronym: TIGHT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 15, 2017
Registry last updated
Jun 18, 2023

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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