Rheumatoid ArthritisTIGHTNCT03188081
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
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 171 participants
- Where
- 1 siteItaly
- Study dates
- 2 Aug 2017to 24 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 24 months
Secondary outcomes (21)
Distribution of socio-demographic data
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Measured: 24 months
Patient Rheumatoid Arthritis History
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Measured: 24 months
Co-morbidities
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Measured: 24 months
Clinical measurements (disease indices and relevant subcomponents)
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Measured: 24 months
Erythrocyte Sedimentation Rate
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Measured: 24 months
Rheumatoid Factor
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Measured: 24 months
Anti Citrullinated Peptide Antibody
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Measured: 24 months
Prior RA treatments
To describe the major characteristics of population of patients in real life conditions at abatacept SC initiation
Measured: 24 months
Patient's reported assessment of health measured by HAQ-DI
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
Measured: 24 months
Health related quality of life measured by EQ-5D
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
Measured: 24 months
Remission rate measured by MAQ
To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population
Measured: 24 months
Low disease activity rate measured by MAQ
To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population
Measured: 24 months
DAS28 score measured by MAQ
To investigate whether a better adherence to the abatacept SC therapy is associated to a better clinical outcome of the patient population
Measured: 24 months
Concomitant medication for RA (Synthetic DMARDs and corticosteroids)
To describe the use of concomitant medication for RA (Synthetic DMARDs and corticosteroids) over the study observation period
Measured: 24 months
Adverse Events
To describe the incidence of Adverse Events, by seriousness and relationship with abatacept SC
Measured: 24 months
Reason for Withdrawal, where applicable
To describe the incidence of the reasons for withdrawal from the treatment and the study
Measured: 24 months
Retention rate
To evaluate the retention rate calculated as the time-to-discontinuation of abatacept SC treatment over the study observation period
Measured: 24 months
Cost-utility analysis (CUA)
To perform a cost-utility analysis (CUA) from the National Health System
Measured: 24 months
Societal perspective comparing health consequences
Societal perspective comparing health consequences Quality Adjusted Life Years (QALYs)
Measured: 24 months
Cost of alternative follow-up strategies
Two alternative follow-up strategies: ESP versus standard control
Measured: 24 months
Patient's reported assessment of health measured by Pain VAS
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start2 Aug 2017
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188081
- Sponsor's protocol ID
- IM101-645
- Acronym
- TIGHT
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2017
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03188081
- Acronym / sponsor ID
- TIGHT / IM101-645
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
21 secondary outcomes
Distribution of socio-demographic data
Time frame: 24 months
Patient Rheumatoid Arthritis History
Time frame: 24 months
Co-morbidities
Time frame: 24 months
Clinical measurements (disease indices and relevant subcomponents)
Time frame: 24 months
Erythrocyte Sedimentation Rate
Time frame: 24 months
Rheumatoid Factor
Time frame: 24 months
Anti Citrullinated Peptide Antibody
Time frame: 24 months
Prior RA treatments
Time frame: 24 months
Patient's reported assessment of health measured by HAQ-DI
Time frame: 24 months
Health related quality of life measured by EQ-5D
Time frame: 24 months
Remission rate measured by MAQ
Time frame: 24 months
Low disease activity rate measured by MAQ
Time frame: 24 months
DAS28 score measured by MAQ
Time frame: 24 months
Concomitant medication for RA (Synthetic DMARDs and corticosteroids)
Time frame: 24 months
Adverse Events
Time frame: 24 months
Reason for Withdrawal, where applicable
Time frame: 24 months
Retention rate
Time frame: 24 months
Cost-utility analysis (CUA)
Time frame: 24 months
Societal perspective comparing health consequences
Time frame: 24 months
Cost of alternative follow-up strategies
Time frame: 24 months
Patient's reported assessment of health measured by Pain VAS
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Medication Adherence Questionnaire (MAQ) (time frame: 12 months and 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.