Rheumatoid ArthritisNCT01094795
Safety Study of Abatacept in Sweden
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
Trial summary
The primary purpose of this study is to assess incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 92,635 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2011to 24 Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents of Sweden
Who may be able to join
- Resident of Sweden
Who cannot join
- None
About this study
Official title: A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Sweden Using the ARTIS Register
The primary purpose of this study is to assess incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept.
- 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 initiating abatacept | Not described | |
| Patients receiving other biologic disease-modifying drugs | Not described | |
| Patients with early rheumatoid arthritis (RA) | Not described | |
| Patients with prevalent RA identified by hospitalization | Not described | |
| General population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalized infection
Measured: Every 6 months throughout the study
Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer)
Measured: Every 6 months throughout the study
Total mortality
Measured: Every 6 months throughout the study
Secondary outcomes (1)
Autoimmune disorders (lupus, psoriasis, multiple sclerosis)
Measured: Every 6 months throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study start31 Mar 2011
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
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
- 92,635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094795
- Sponsor's protocol ID
- IM101-125
- Status last verified
- Jun 2022
- First submitted
- 24 Mar 2010
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Sweden Using the ARTIS Register
- ClinicalTrials.gov ID
- NCT01094795
- Acronym / sponsor ID
- IM101-125
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92,635 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet
- Study start
- 31 Mar 2011 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 29 Mar 2010 (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 primary purpose of this study is to assess incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients initiating abatacept | – | – |
| Patients receiving other biologic disease-modifying drugs | – | – |
| Patients with early rheumatoid arthritis (RA) | – | – |
| Patients with prevalent RA identified by hospitalization | – | – |
| General population | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of Sweden
Key inclusion criteria (1 listed)
- Resident of Sweden
Key exclusion criteria (1 listed)
- None
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
Hospitalized infection
Time frame: Every 6 months throughout the study
Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer)
Time frame: Every 6 months throughout the study
Total mortality
Time frame: Every 6 months throughout the study
1 secondary outcome
Autoimmune disorders (lupus, psoriasis, multiple sclerosis)
Time frame: Every 6 months throughout the study
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 16 Jun 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
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 1 inclusion and 1 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 16 Jun 2022. 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?
Hospitalized infection (time frame: Every 6 months throughout the study). The study lists 3 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 16 Jun 2022.