Rheumatoid ArthritisNCT02169544
Post-marketing Study Assessing the Long-Term Safety of Abatacept
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to evaluate the risk of infections and malignancies among Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Abatacept
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2014to 28 Feb 2017
- 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: Patients will be selected from 4 US claims databases
Who may be able to join
- Patient has at least two claims for RA (714.xx) in the 180 days prior to and including the index date (baseline period)
- Patient is aged 18 years or older on the index date
- Patient was enrolled in the database for at least 180 days before the index date
- Patient is newly prescribed Abatacept or another RA treatment and has at least two claims for the treatment
Who cannot join
None listed.
About this study
The purpose of this study is to evaluate the risk of infections and malignancies among Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Abatacept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
| Study group | Role | What they receive |
|---|---|---|
| RA patients who are prescribed Abatacept | Abatacept Receives: Drug: Abatacept | |
| Patients who are prescribed other RA treatments | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Lung Cancer
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Measured: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Risk of lymphoma
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Measured: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Risk of breast cancer
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Measured: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Risk of non-melanoma skin cancer
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Measured: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Risk of all malignancies
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Measured: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Risk of hospitalized infections
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Measured: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
Risk of pneumonia
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Measured: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
Risk of opportunistic infections
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Measured: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
Risk of tuberculosis
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Measured: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
Secondary outcomes (3)
Incidence of lupus
The index date is defined as the date that the patient initiates Abatacept
Measured: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Incidence of multiple sclerosis
The index date is defined as the date that the patient initiates Abatacept
Measured: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Incidence of psoriasis
The index date is defined as the date that the patient initiates Abatacept
Measured: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start31 Jan 2014
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
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
- Retrospective
- Enrolment
- 100,000 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
- NCT02169544
- Sponsor's protocol ID
- IM101-488
- Status last verified
- Apr 2017
- First submitted
- 14 May 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Study Assessing the Long-Term Safety of Abatacept
- ClinicalTrials.gov ID
- NCT02169544
- Acronym / sponsor ID
- IM101-488
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2014 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 23 Jun 2014 (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.
The purpose of this study is to evaluate the risk of infections and malignancies among Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients who are prescribed Abatacept | – | Drug: AbataceptAbatacept |
| Patients who are prescribed other RA treatments | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from 4 US claims databases
Key inclusion criteria (4 listed)
- Patient has at least two claims for RA (714.xx) in the 180 days prior to and including the index date (baseline period)
- Patient is aged 18 years or older on the index date
- Patient was enrolled in the database for at least 180 days before the index date
- Patient is newly prescribed Abatacept or another RA treatment and has at least two claims for the treatment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abatacept | Drug | RA patients who are prescribed Abatacept |
Primary outcome
Risk of Lung Cancer
Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of lymphoma
Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of breast cancer
Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of non-melanoma skin cancer
Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of all malignancies
Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of hospitalized infections
Time frame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of pneumonia
Time frame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of opportunistic infections
Time frame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of tuberculosis
Time frame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
3 secondary outcomes
Incidence of lupus
Time frame: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Incidence of multiple sclerosis
Time frame: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
Incidence of psoriasis
Time frame: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
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 25 Apr 2017.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
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 4 inclusion and 0 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Risk of Lung Cancer (time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)). The study lists 9 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 25 Apr 2017.