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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03188081
Date of registration: 12/06/2017
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb
Public title: 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
Scientific 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
Date of first enrolment: August 4, 2017
Target sample size: 300
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03188081
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Italy
Contacts
Name:     Site 0001
Address: 
Telephone:
Email:
Affiliation: 
Name:     Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address: 
Telephone: please email:
Email: Clinical.Trials@bms.com
Affiliation: 
Name:     Bristol-Myers Squibb
Address: 
Telephone:
Email:
Affiliation:  Bristol-Myers Squibb
Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
Adherence ratio [Time Frame: 24 months]
Change in Medication Adherence Questionnaire (MAQ) [Time Frame: 12 months and 24 months]
Secondary Outcome(s)
Adverse Events [Time Frame: 24 months]
Anti Citrullinated Peptide Antibody [Time Frame: 24 months]
Clinical measurements (disease indices and relevant subcomponents) [Time Frame: 24 months]
Co-morbidities [Time Frame: 24 months]
Concomitant medication for RA (Synthetic DMARDs and corticosteroids) [Time Frame: 24 months]
Cost of alternative follow-up strategies [Time Frame: 24 months]
Cost-utility analysis (CUA) [Time Frame: 24 months]
DAS28 score measured by MAQ [Time Frame: 24 months]
Distribution of socio-demographic data [Time Frame: 24 months]
Erythrocyte Sedimentation Rate [Time Frame: 24 months]
Health related quality of life measured by EQ-5D [Time Frame: 24 months]
Low disease activity rate measured by MAQ [Time Frame: 24 months]
Patient Rheumatoid Arthritis History [Time Frame: 24 months]
Patient's reported assessment of health measured by HAQ-DI [Time Frame: 24 months]
Patient's reported assessment of health measured by Pain VAS [Time Frame: 24 months]
Prior RA treatments [Time Frame: 24 months]
Reason for Withdrawal, where applicable [Time Frame: 24 months]
Remission rate measured by MAQ [Time Frame: 24 months]
Retention rate [Time Frame: 24 months]
Rheumatoid Factor [Time Frame: 24 months]
Societal perspective comparing health consequences [Time Frame: 24 months]
Secondary ID(s)
IM101-645
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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