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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 (TIGHT)

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ClinicalTrials.gov Identifier: NCT03188081
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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).

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Abatacept

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : August 4, 2019
Estimated Study Completion Date : August 4, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Cohort A
Adult RA patients followed up according to local clinical practice only at the hospital wards
Drug: Abatacept
Subcutaneous

Cohort B
Adult RA patients followed up according to local clinical practice at the Hospital wards and additionally at their home through a support program
Drug: Abatacept
Subcutaneous




Primary Outcome Measures :
  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 Outcome Measures :
  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



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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:   Probability Sample
Study Population
Adult RA patients, 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 Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Criteria

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)

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): NCT03188081


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Italy
Local Institution Recruiting
Brescia, Italy, 25123
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
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: NCT03188081     History of Changes
Other Study ID Numbers: IM101-645
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Connective Tissue Diseases
Abatacept
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents