Rheumatoid ArthritisNCT03696173
Safety Study of Abatacept in Rheumatoid Arthritis Participants
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer 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?
- Non-Interventional
- How many people
- 5,800 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2015to 29 Jun 2018
- 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: Rheumatoid arthritis (RA) participant, population-based cohort study approach within the US-based Truven MarketScan population and Supplemental US Medicare database
Who may be able to join
- Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date
- Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date
- Patient is aged 18 years or older on the entry date
- Patient was enrolled in the database for at least 180 days before the entry date
Who cannot join
- Patient is younger than 18 years on the entry date
- Patients who receive abatacept and another biologic simultaneously
- Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Safety of Biologic Disease-modifying Treatment Initiation With Abatacept in Rheumatoid Arthritis: A Real-world Population-based Observational Study
A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer
- Conditions
- Rheumatoid Arthritis
- Being tested
- Non-Interventional
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Participants taking abatacept | Not described Receives: Other: Non-Interventional | |
| Participants taking abatacept with methotrexate | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of increased risk of serious infection while taking abatacept
With methotrexate
Measured: Approximately 7 years
Incidence of malignancy while taking abatacept
With methotrexate
Measured: Approximately 7 years
Incidence of increased risk of serious infection while taking abatacept
Without methotrexate
Measured: Approximately 7 years
Incidence of malignancy while taking abatacept
Without methotrexate
Measured: Approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start17 Dec 2015
- Primary completion29 Jun 2018
- Study completion29 Jun 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,800 participants (estimated)
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
- NCT03696173
- Sponsor's protocol ID
- IM101-605
- Status last verified
- Sep 2018
- First submitted
- 3 Oct 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Safety of Biologic Disease-modifying Treatment Initiation With Abatacept in Rheumatoid Arthritis: A Real-world Population-based Observational Study
- ClinicalTrials.gov ID
- NCT03696173
- Acronym / sponsor ID
- IM101-605
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,800 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 4 Oct 2018 (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.
A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants taking abatacept | – | Other: Non-Interventional |
| Participants taking abatacept with methotrexate | – | Other: Non-Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis (RA) participant, population-based cohort study approach within the US-based Truven MarketScan population and Supplemental US Medicare database
Key inclusion criteria (4 listed)
- Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date
- Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date
- Patient is aged 18 years or older on the entry date
- Patient was enrolled in the database for at least 180 days before the entry date
Key exclusion criteria (4 listed)
- Patient is younger than 18 years on the entry date
- Patients who receive abatacept and another biologic simultaneously
- Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Participants taking abatacept |
| Non-InterventionalNon-Interventional | Other | Participants taking abatacept with methotrexate |
Primary outcome
Incidence of increased risk of serious infection while taking abatacept
Time frame: Approximately 7 years
With methotrexate
Incidence of malignancy while taking abatacept
Time frame: Approximately 7 years
With methotrexate
Incidence of increased risk of serious infection while taking abatacept
Time frame: Approximately 7 years
Without methotrexate
Incidence of malignancy while taking abatacept
Time frame: Approximately 7 years
Without methotrexate
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 4 Oct 2018.
- BMS Clinical Trial InformationLink 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 United States.
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 4 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 4 Oct 2018. 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 United States. 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?
Incidence of increased risk of serious infection while taking abatacept (time frame: Approximately 7 years). The study lists 4 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 4 Oct 2018.