Rheumatoid ArthritisNCT02335606
Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in Taiwan.
Trial summary
Abatacept Registry in Taiwan Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- Type of treatment
- Injection or infusion
- How many people
- 213 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Aug 2014to 31 Dec 2018
- How long will I take part?
- 2 Years
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital : Research based hospital centers, Teaching hospitals affiliated with medical schools, National/Regional medical centers and/or in which thought leaders are employed
Who may be able to join
- ≥ 20 years of age
- Who give informed consent
- Confirmed diagnosis of RA (as defined by American College of Rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment
- Who self-pay or who are reimbursed by BNHI for abatacept treatment
- With latent TB or who are receiving anti-TB treatment (INH 300 mg, QD) 1 month prior to using abatacept and continuously up to a total of 9 months Willing to follow Taiwan Risk Management Plan guidelines as required by Taiwan health authorities
- Are being treated with abatacept or are abatacept treatment naïve and are initiating abatacept therapy
Who cannot join
- Pregnant or breast feeding
- With active TB
- HBsAg (+)and/or Anti-HCV(+) and/or HBV DNA(+)
- Have cancer (patients who were treated and have no sign of cancer for > 10 years can be included)
- Are allergic to abatacept
- Enrolled in other RA clinical studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan
Abatacept Registry in Taiwan
- 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 |
|---|---|---|
| Patients treating with Abatacept | Patients who are abatacept naive and are initiating abatacept treatment (either IV or SC) including those that are switching from another bDMARD, as well as, patients currently being treated with IV or SC abatacept some of which may have switched from IV abatacept to SC abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.
Treatment retention rate is defined as the proportion of subjects who use abatacept for 24 months
Measured: approximately 24 months
Secondary outcomes (5)
The retention rate (%) of abatacept therapy at 6, 9, 12, and 18 months in RA patients
Measured: at 6, 9, 12, 18, and 24months after study participation
The time to treatment discontinuation in RA patients treated with abatacept
Treatment discontinuation is defined as patients who cease treatment for > 8 weeks
Measured: at 6, 9, 12, 18, and 24months after study participation
The proportion of patients achieving DAS28 ≤ 2.6, 2.6 < DAS28 ≤ 3.2, 3.2 < DAS28 ≤ 5.1, DAS> 5.1 at 6, 9, 12, 18, and 24months
Measured: at 6, 9, 12, 18, and 24months after study participation
The major reason for treatment discontinuation (eg, lack of efficacy, severe adverse drug reactions, switch from abatacept to another RA medication, financial issues, etc) at 6, 9, 12, 18, and 24 months
Measured: at 6, 9, 12, 18, and 24months after study participation
The demographic, clinical presentation, and disease management a composite measure of RA patients who are using abatacept (either formulation) or are abatacept naïve at Month 6, 9, 12, 18, and 24
Measured: at 6, 9, 12, 18, and 24months after study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study start6 Aug 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
- Target duration
- 2 Years
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
- NCT02335606
- Sponsor's protocol ID
- IM101-440
- Status last verified
- Jan 2022
- First submitted
- 7 Jan 2015
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan
- ClinicalTrials.gov ID
- NCT02335606
- Acronym / sponsor ID
- IM101-440
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Jan 2015 (estimated)
- 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.
Abatacept Registry in Taiwan
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treating with Abatacept | – | –Patients who are abatacept naive and are initiating abatacept treatment (either IV or SC) including those that are switching from another bDMARD, as well as, patients currently being treated with IV or SC abatacept some of which may have switched from IV abatacept to SC abatacept |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital : Research based hospital centers, Teaching hospitals affiliated with medical schools, National/Regional medical centers and/or in which thought leaders are employed
Key inclusion criteria (6 listed)
- ≥ 20 years of age
- Who give informed consent
- Confirmed diagnosis of RA (as defined by American College of Rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment
- Who self-pay or who are reimbursed by BNHI for abatacept treatment
- With latent TB or who are receiving anti-TB treatment (INH 300 mg, QD) 1 month prior to using abatacept and continuously up to a total of 9 months Willing to follow Taiwan Risk Management Plan guidelines as required by Taiwan health authorities
Key exclusion criteria (6 listed)
- Pregnant or breast feeding
- With active TB
- HBsAg (+)and/or Anti-HCV(+) and/or HBV DNA(+)
- Have cancer (patients who were treated and have no sign of cancer for > 10 years can be included)
- Are allergic to abatacept
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
The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.
Time frame: approximately 24 months
Treatment retention rate is defined as the proportion of subjects who use abatacept for 24 months
5 secondary outcomes
The retention rate (%) of abatacept therapy at 6, 9, 12, and 18 months in RA patients
Time frame: at 6, 9, 12, 18, and 24months after study participation
The time to treatment discontinuation in RA patients treated with abatacept
Time frame: at 6, 9, 12, 18, and 24months after study participation
The proportion of patients achieving DAS28 ≤ 2.6, 2.6 < DAS28 ≤ 3.2, 3.2 < DAS28 ≤ 5.1, DAS> 5.1 at 6, 9, 12, 18, and 24months
Time frame: at 6, 9, 12, 18, and 24months after study participation
The major reason for treatment discontinuation (eg, lack of efficacy, severe adverse drug reactions, switch from abatacept to another RA medication, financial issues, etc) at 6, 9, 12, 18, and 24 months
Time frame: at 6, 9, 12, 18, and 24months after study participation
The demographic, clinical presentation, and disease management a composite measure of RA patients who are using abatacept (either formulation) or are abatacept naïve at Month 6, 9, 12, 18, and 24
Time frame: at 6, 9, 12, 18, and 24months after study participation
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 21 Jan 2022.
- 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 Taiwan.
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 6 inclusion and 6 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 21 Jan 2022. 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 Taiwan. 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?
The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan. (time frame: approximately 24 months). 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 21 Jan 2022.