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

NCT03188081 | Completed

• 1 other identifier: IM101-645
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Change in Medication Adherence Questionnaire (MAQ)

  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)

  12 months and 24 months

• Adherence ratio

  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

  24 months

Secondary Outcomes (21)

• Distribution of socio-demographic data

  24 months

• Patient Rheumatoid Arthritis History

  24 months

• Co-morbidities

  24 months

• Clinical measurements (disease indices and relevant subcomponents)

  24 months

• Erythrocyte Sedimentation Rate

  24 months

Study Arms (2)

Cohort A

Adult RA patients followed up according to local clinical practice only at the hospital wards

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Brescia, 25123, Italy

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 15, 2017
• Study Start: August 2, 2017
• Primary Completion: August 24, 2020
• Study Completion: August 24, 2020
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

IT (1)